RESOLUTION - RDC No 59, JUNE 27, 2000

The Collegiate Directory of the National Sanitary Surveillance Agency, within its

attributions, granted to it by the art. 11, subparagraph IV, of the ANVISA Regulation, approved

by the Decree No. 3.029, from April 16, 1999 in a meeting called on June 20, 2000,

whereas Law No. 6.360, from September 23, 1976; and its regulation Decree No. 79.094, from

January 5, 1977;

whereas the need to establish and implement requirements for Good Manufacturing Practices

of establishments that manufacture or market medical devices, to ensure the process quality

and control of risk factors to consumer health, based on harmonized instruments in Mercosur;.

whereas the need for standards for audit and inspection of Good Manufacturing Practices for

medical devices;

whereas the need to internalize the resolution Mercosur/GMC/Res. No 04/95 and Resolution

MERCOSUR/GMC/Res. No 131/96,

adopts the following Collegiate Directory Resolution and I, CEO, determine its publication:

Article. 1 To determine to all manufacturing sites of medical devices, the fulfillment of the

guidelines established in the Technical Regulation of Good Manufacturing Practice of Medical

Devices, according to Annex I of this Resolution.

Paragraph 1 Establishments that store distribute or market medical devices should also comply

with the provisions of Annex I to this resolution, as applicable.

Paragraph 2 Other devices of interest for the public health risk control, achieved by the

National Health Surveillance System - SNVS and designated by the National Sanitary

Surveillance Agency ANVISA, equate to medical devices referred in this Article, being subject to

the provisions of this Resolution.

Article 2 The inspection of providers of medical devices will be performed by inspectors from

National Health Surveillance System SNVS, who will use the requirements for "Verifying

Compliance with Good Manufacturing Practices of Medical Devices” according to Annex II of

this Resolution.

Article 3 The non-accomplishment to the Good Manufacturing Practices for Medical Devices

will subject the suppliers of these devices to sanctions and penalties foreseen in the current

legislation.

Article 4 This resolution comes into force on the date of its publication.

GONZALO VECINA NETO

Establish and implement requirements

for Good Manufacturing Practices of

establishments that manufacture or

market medical devices

ANNEX I

GOOD MANUFACTURING PRACTICES FOR MEDICAL DEVICES

TABLE OF CONTENTS

Part A – General Provisions

1. Scope

2. Definitions

3. Quality Systems

Part B – Quality System Requirements

1. Management Responsibility

2. Quality Audit

3. Personnel

Part C – Project Control

Part D – Documents and Records Control

Part E – Purchasing Control

Parte F – Identification and Traceability

1. Identification and Traceability

2. High risk devices (class III or IV) traceability

Part G In-process and Production Control

1. In-process and Production Control

2. Special procedures

Part H Inspection and Tests

1. Inspection and tests

2. Inspection, measuring, and test equipment

3. Results of inspection and tests

Part I Nonconforming Components and Products

Part J Corrective Action

Part K Handling, Storage, Distribution and Installation

1. Handling

2. Storage

3. Distribution

4. Installation

Parte L Packaging and Labeling Control

1. Device Packaging

2. Device Labeling

3. Critical Device Labeling

Parte M Records

1. General Requirements

2. Device Master Record (DMR)

3. Device History Record

4. Complaint Files

Part N Servicing

Part O Statistical Techniques

Part A General Provisions

1. Scope

(a) Applicability. This standard establishes applicable requirements for the manufacture of

medical devices. Those requirements describe the Good Manufacturing Practices (GMP) for

methods and controls applicable in design, purchase, manufacturing, labeling, packing,

storage, installation and servicing for medical devices. The requirements of this standard are

intended to ensure that medical devices are safe and effective.

(2) The requirements of this rule are applicable to any medical devices that are manufactured

or imported to me marketed in Brazil.

(b) Consequences of non-compliance. (1) The failure to comply with any applicable

requirements of this regulation regarding the design, manufacture, packaging, labeling,

storage, installation, and servicing renders a device adulterated. Such a device, as well as any

person responsible for the failure to comply, is subject to regulatory action from Surveillance

Agency.

(2) In the case a manufacturer who sells devices in the country refuses to schedule an

inspection at its facilities to check compliance hereof, it shall mean, for the purposes of the

law, that the methods and controls used in the design, purchase, manufacturing, packaging,

labeling, storage, installation and servicing of any device manufactured at its facilities are not

in compliance with the requirements hereof.

2. Definitions

(a) Servicing: maintenance or repair of a finished device in order to return it to its

specifications.

(b) Quality audit means an established, systematic and independent examination of a

manufacturer’s quality system that is performed at defined intervals and at sufficient

frequency to ensure that both quality system activities and the results of such activities comply

with quality system procedures, that these procedures are implemented effectively, and that

these procedures are suitable to achieve quality system objectives.

(c) Component: raw material, substance, piece, part, software, hardware, packaging and labels

used during the manufacture of a medical device which is intended to be included as part of

the finished, packaged and labeled device.

(d) Design input data: physical and performance requirements of a medical device that are

used as a basis for device design.

(e) Design output data: results of a design effort at each design phase and at the end of total

design effort. The finished design output consists of the device, its packaging and labeling,

related specifications, drawings, production and specifications of the quality system which are

added to the product master record (PMR).

(f)Specification: documents prescribing any requirement with which a product, process,

service, or quality system must conform.

(g) To establish: define, document and implement.

(h) Manufacturer: any person who designs, manufacturers, assembles, or processes a finished

device Including other persons authorized or qualified to sterilize, label and/or pack, as well as

importers.

(i) Management with executive responsibility: those senior employees of a manufacturer who

have the authority to establish or make changes to the manufacturer's quality policy, quality

system requirements or make changes in the product design procedures or its production,

distribution, technical assistance, maintenance or installation.

(j) Law: a country’s regulation to be prepared based on this rule.

(k) Lot or batch: amount of a product prepared in a manufacturing or sterilization procedure,

the basic characteristic of which is homogeneity.

(l) Manufacturing material: material or substance, not including the finished product, used in

the manufacturing process or in order to facilitate said process, including cleaning products,

mold release agents, lubricant oils, sterilizing agents, such as ethylene oxide and others, or

other byproducts produced during the manufacturing process.

(m) Nonconformity: component, manufacturing material or finishing device out of the

specifications, before or after its distribution.

(n) Control number: distinctive combination of letters or numbers, or both, from which the

history of the purchase, manufacturing, packaging, labeling, and distribution of a lot or batch

of other finished devices can be determined.

(o) Quality policy: the overall intentions and directions of an organization with respect to

quality, as formally established by management with executive responsibility.

(p) Special process: any process, which results may not be completely checked by means of

tests and subsequent inspections.

(q) Production: all activities performed after the design transference to the point of

distribution.

(r) Finished device: any device or accessory to any device that is suitable for use, packaged or

labeled, only requiring the final approval for commercial distribution.

(s) Medical device: equipment, apparatus, material, article or system for medical,

odontological or laboratory use or application, aimed at the prevention, diagnosis, treatment,

rehabilitation or contraception, and which does not achieve its principal intended action in or

on the human body by pharmacological, immunological or metabolic means, but which may be

assisted in its function by such means.

(t) Quality: the totality of features and characteristics that bear on the ability of a device to

satisfy fitness-for-use, including safety and performance.

(u) Complaint: any written, oral, or electronic, communication related to the refusal to the

identity, quality, durability, reliability, safety, effectiveness, or performance of a device.

(v) Record: written or automated document, including specifications, procedures, protocols,

standards, methods, instructions, plans, files, notes, reviews, analyses and reports.

(w) Device history record (DHR) means a compilation of records containing the production

history of a finished device.

(x) Design history file (DHF): a compilation of records which describes the design history of a

finished device.

(y) Device master record (DMR): compilation of

records containing the complete drawings of the product, its formulation and specifications,

manufacturing and purchase procedures and specifications, quality system procedures and

requirements and finished product procedures related to packaging, labeling, servicing,

maintenance and installation.

(z) Rework: part or the entire manufacturing operation intended to correct nonconformity of a

component or a finished device.

(aa) Design review: systematic and complete examination of a design to evaluate the adequacy

of the design requirements, to evaluate the capability of the design to meet these

requirements, to identify problems and to provide solution for such problems.

(bb) Quality system: organizational structure, responsibilities, procedures, specifications,

processes and resources required for implementing quality management.

(cc) Device Validation: to establish and document evidences that device specifications are

conform to the intended use. Concerning a process, it means to establish and document

evidences that a process consistently produces a result meeting its predetermined

specifications and quality attributes.

(dd) Verification: confirmation and documentation, when valid, of the objective evidence that

the specified requirements have been fulfilled. Verification includes the process of evaluating

activity results in order to determine its compliance with defined specifications for that activity

and to ensure the device is suitable for the intended use.

3. Quality System

Each manufacturer shall establish and maintain a quality system in order to ensure the

requirements set forth in this rule are fulfilled and that manufactured devices are safe,

effective and, in general, adequate for the intended use. As part of its activities in the quality

system, each manufacturer shall:

(a) Establish effective instructions and procedures of the quality system according to the

requirements hereof; and

(b) Effectively maintain the instructions and procedures set for the quality system.

Part B – Quality System Requirements

1. Management responsibility

(a) Quality Policy. Management with executive responsibility shall establish its policy and

objectives for, and commitment to, quality. Management with executive responsibility shall

maintain the policy at all levels of the organization. Management with executive responsibility

shall ensure that the quality policy is understood, at all employees who may affect or influence

the quality of a product.

(b) Organization. Each manufacturer shall establish and maintain an adequate organizational

structure with enough personnel to ensure that devices are produced in accordance with the

requirements of this part.

(1) Responsibility and Authority: Respectively to each section hereof, each manufacturer shall

establish the appropriate responsibility, authority and interrelation of all personnel that

manage, perform, and assess work affecting quality, particularly the personnel requiring

organizational independence and authority to:

(i) Start or implement measures in order to avoid the occurrence or use of nonconforming

components, manufacturing materials or finished devices;

(ii) Identify or document quality problems with

devices, production or the quality system;

(iii) Start, recommend, provide or implement solutions or corrective measures to quality

problems;

(iv) Verify the compliance and implementation of solutions or corrective measures to quality

problems; and

(v) Manage or control additional processing, distribution or installation of nonconforming

components, manufacturing materials or finished devices.

(2) Resources and personnel for verification. Each manufacturer shall establish verification

functions and shall provide adequate resources and assign adequately trained personnel to

perform verification activities.

(3) Management representative. Management with executive responsibility shall appoint a

member of management who, irrespective of other responsibilities, shall have established

authority over and responsibility for:

(i) Ensuring that quality system requirements are effectively established and effectively

maintained in accordance with this part; and

(ii) Reporting on the performance of the quality system to management with executive

responsibility for review and provide information on the quality system improvement.

Appointment of this employee shall be documented.

(c) Management review: Management with executive responsibility shall review the suitability

and effectiveness of the quality system at defined intervals and with sufficient frequency

according to established procedures to ensure that the quality system satisfies the

requirements of this part and the manufacturer's established quality policy and objectives.

Management review shall be performed according to the established review procedures and

results of quality system reviews shall be documented.

2. Quality audit

(a) Each manufacturer shall conduct quality audits to ensure that the quality system is in

compliance with the established requirements. Quality audits shall be conducted by duly

trained persons, according to the audit procedures defined, who do not have direct

responsibility for the matters being audited. A report of the results of each quality audit shall

be made and such reports shall be reviewed by management having responsibility for the

matters audited. Corrective action(s), including a reaudit of deficient matters, shall be taken

when necessary and documented in the audit report.

3. Personnel

(a) General Instructions. Each manufacturer shall have sufficient personnel with the necessary

education, background, training, and experience to ensure that all activities required by this

part are correctly performed.

(b) Training. Each manufacturer shall ensure that all personnel is trained to appropriately

perform the tasks assigned to them. Training shall be conducted according to the procedures

established by duly qualified persons to ensure the employees perfectly understand their

regular functions and requirements of this part applicable to their functions. As part of their

training, personnel shall be made aware of device defects, which may occur from the improper

performance of their specific jobs. Personnel who perform verification activities shall be made

aware of defects and errors that may be encountered as part of their job functions. Personnel

training shall be documented.

(c) Consultants: (1) Each manufacturer shall ensure that any consultant advising on the

methods used in, or controls used for design, purchasing, manufacture, packaging, labeling,

storage, installation or servicing of devices has

sufficient qualifications (education, training, and experience) to advise on the subjects the

consultant will advise.

(2) Each manufacturer shall maintain records pertaining to each consultant. Such records shall

include the consultant’s name, address and qualifications, including a copy of the curriculum

vitae and a list of previous jobs, as well as a specific description of the subjects the consultant

advised.

Part C – Design Controls

(a) General Instructions: (1) Each manufacturer of medical devices belonging to class II or III

(medium risk) or IV (high risk), shall establish and maintain procedures to control and verify

the design of the device in order to ensure that specified requirements for are met.

(b) Design and development planning. Each manufacturer shall establish and maintain plans

that identify the development activities and personnel responsible for each activity. The plans

shall describe or reference the design and development activities including any interaction

among the several organizational and technical groups. The plans shall be updated, as design

and development evolves.

(c)Design input. Each manufacturer shall establish design input data requirements related to

the device. Requirements shall completely refer to the intended use of the device, including

the needs of the user (patient or operator) and shall be reviewed and approved by a

designated individual(s). The approval, including the date and signature of the individual(s)

approving the requirements, shall be documented.

(d) Design review. Each manufacturer shall establish and maintain procedures to verify devices

design and assign such function to designated individual. Design verification shall be timely

performed and shall confirm that the design output data fulfills the input data requirements

and that it is adequate for the intended use. The results of a design review, including

identification of the design, methods, the date, and the individual(s) performing the review,

shall be documented in the design history file (the DHF). Where applicable, design verification

shall include software validation and risk analysis.

(e) Design verification. Each manufacturer shall formally review design output data according

to the established requirements. Each manufacturer shall assign the design review

responsibility to qualified persons directly responsible for the design development.

Appointments shall be documented. The results of the design verification shall be documented

in the DHF.

(f) Design output. Each manufacturer shall establish and documenting design output in terms

that allow an adequate evaluation of conformance to design input requirements. Design

output procedures shall fulfill the input data requirements and include design characteristics

essential for the device intended use.

(g) Design transfer. Each manufacturer shall establish and maintain procedures to ensure that

the design basis for a device and its components are correctly translated into production

specifications. Production specifications shall be approved by an individual designated by the

manufacturer. The approval, including identification of the design, the date, and the person

approving the specifications, shall be documented. Each manufacturer shall select a

representative sample of a device from the first three production lots or batches and test such

sample under actual or simulated use conditions. Each manufacturer shall conduct such testing

according to the established procedures and shall maintain record of all results of the testing.

Each manufacturer shall also conduct such testing when changes are made in the device or

manufacturing process.

(h) Design release. Each manufacturer shall ensure

that the design is not released for production until the design is approved by the individuals

designated by the manufacturer. The designated individuals shall review all records required

for the design history record to ensure that the design history file is complete and that the

final design is consistent with the approved design plan before releasing the design. The

release, including date and signature of the individual approving release, shall be documented.

(i) Design changes. Each manufacturer shall establish and maintain procedures for the

identification, documentation, validation, review and approval of design changes.

(j)Design history file. Each manufacturer shall establish and maintain a DHF for each type of

device. The DHF shall contain or reference the records necessary to demonstrate that the

design was developed in accordance with the approved design plan and the requirements of

this part.

Part D – Documents and Record Controls

Each manufacturer shall establish and maintain document control procedures to ensure that

all documents that must be established and maintained, under this part and are accurate and

adequate for their intended use.

(a) Documents approval and issue: Each manufacturer shall designate individuals to review and

approve all documents established under this part for adequacy prior to issuance. The

approval, including date and signature of the individual approving the document, shall be

documented.

(b) Documents distribution. Each manufacturer shall ensure that all documents are current and

available at all locations for which they are designated, and all obsolete documents shall be

promptly removed from all points of use in a timely manner.

(c) Documents change. Changes in specifications, methods or procedures for components,

finished devices, manufacturing materials, production, installation, servicing or related to

quality systems shall be documented, reviewed and approved by the individuals in the same

function or organization that performed the original review and approval, unless specifically

designated otherwise. Approved changes shall be communicated to the appropriate personnel

in a timely manner. When specifications, methods or procedures are changed, each

manufacturer shall evaluate changes according to the established procedures. Evaluation and

results shall be recorded.

(d) Records of document changes. Each manufacturer shall maintain records of changes to

documents. Change records shall include a description of the change, identification of affected

documents, the signature of the approving individual, the approval date, and when the change

becomes effective. A list, index or equivalent procedures for the control of documents shall be

established and maintained to identify the current situation in order to ensure the used of

current and approved documents only.

Part E – Purchasing Controls

Each manufacturer shall establish and maintain procedures to ensure that all components,

manufacturing materials and finished devices manufactured, processed, labeled or packaged

by third part or maintained by them under an agreement, are in compliance with their

specifications. Each manufacturer shall also ensure that services provided by others are in

compliance with the specifications.

(a) Evaluation of suppliers and contractors. Each manufacturer shall establish and maintain

evaluation criteria for suppliers and contractors specifying the requirements, including quality

requirements that suppliers and contractors shall

met. Each manufacturer shall evaluate and select potential suppliers and contractors on the

basis of their ability to meet specified requirements, including quality requirements, and shall

establish and maintain a list of suppliers and contractors meeting the manufacturer evaluation

documented criteria. Evaluation and results shall be recorded.

(b) Purchase forms. Each manufacturer shall establish and maintain purchase forms that

clearly describe or reference the specified requirements, including quality requirements,

components, manufacturing materials, finished devices or requested or contracted services.

Purchasing documents shall include, where possible, an agreement that the suppliers agree to

notify the manufacturer of changes in the product or service so that manufacturers may

determine whether the changes may affect the quality of a finished device. Each manufacturer

shall review and approve purchase documents before their release. The approval of the

documents, including the date and signature of the designated individual, shall be

documented.

Part F – Identification and Traceability

1. Identification and traceability

Each manufacturer shall establish and maintain procedures for identifying components,

manufacturing materials and finished devices during all stages of production, distribution and

installation to prevent mixups and ensuring appropriate supply of orders. For certain products,

additional traceability requirements are applicable according to parts F-2 and L-3 of this part.

2. High risk devices (class III or IV) – traceability

Each manufacturer shall identify every unit, lot or batch of high risk devices (class III or IV) by

means of a control number. Such identification shall be registered in the Device master record.

Part G – Process and Production Controls

1. Process and production controls

(a) General instructions. Each manufacturer shall develop, conduct, and control, all production

processes to ensure that a device conforms to its specifications. Where deviations from device

specifications could occur as a result of the manufacturing process, the manufacturer shall

establish and maintain process control procedures that describe any process controls

necessary to ensure conformance to specifications. Where process controls are needed they

shall include:

(1) Documented instructions, standard operating procedures, and methods that define and

control the manner of production, installation and servicing;

(2) Monitoring and control of process parameters and component and device characteristics

during production, installation and servicing;

(3) Compliance with specified reference rules, standards or codes and process control

procedures;

(4) The approval of processes and process equipment; and

(5) Criteria for workmanship which shall be expressed in documented standards or by means

of identified and approved representative samples.

(b) Environmental control. Each manufacturer shall establish and maintain a control system to

avoid contamination or other adverse effects on the product and provide appropriate working

conditions for all operations. Conditions to be regarded for such control include: illumination,

ventilation, space, temperature, humidity,

barometric pressure, aerial contamination, static electricity and other environmental

conditions. Each manufacturer shall inspect its facilities and review its control system

periodically in order to check whether the system is appropriate and works correctly. The

results of such inspections shall be recorded and reviewed.

(c) Cleaning and sanitation. Each manufacturer shall establish and maintain adequate cleaning

procedures, and a schedule complying with the requirements of the manufacturing process

specifications. Each manufacturer shall ensure that all personnel involved understand such

procedures.

(d) Personal health and care. Each manufacturer shall ensure that personnel in contact with a

certain product or environment are clean, healthy and appropriately dressed; otherwise,

absence of personal care, health and appropriate clothes may cause adverse effects on

product quality. Any person that does not seem to be clean or wearing appropriate clothes

shall be excluded from operations until they are clean and appropriately dressed. Any person

that, by means of a medical examination or observation of supervisors, seem to be in a

condition that may affect the product quality, shall be excluded from the operations until such

conditions are fixed. Each manufacturer shall instruct personnel to report such conditions to

supervisors.

(1) Clothes. When special clothes are required to ensure a product is appropriate for the

intended use, each manufacturer shall provide clean clothes for the personnel.

(2) Hygiene. Each manufacturer shall provide appropriate sanitary installations.

(3) Personal habits. When drinking, smoking and other activities of personnel may have

adverse effects on the product quality, each manufacturer shall limit such habits to

appropriate locations. Each manufacturer shall ensure the personnel understand such limits.

Each manufacturer shall designate selected areas in order to avoid any adverse effect on the

products.

(e) Contamination control. Each manufacturer shall establish and maintain procedures to

prevent contamination of equipment, manufacturing materials and product being processed

or finished due to the use of rat poisons, insecticides, fungicides, fumigants, cleaning and

disinfecting materials and hazardous substances, including hazardous substances or

contaminants resulting from the manufacturing process.

(f) Removal of trash and chemical sewage. Each manufacturer shall safely, timely and cleanly

remove trash, chemical effluents and byproducts.

(g) Equipment. Each manufacturer shall ensure that all equipment used in the manufacturing

process meets specified requirements and is appropriately designed, constructed, placed and

installed to facilitate maintenance, adjustments, cleaning, and use.

(1) Maintenance schedule. Each manufacturer shall establish and maintain schedules for the

maintenance, adjustments and, when necessary, equipment cleaning to ensure that

manufacturing specifications are met. Maintenance activities posted on or near equipment, or

further handed over to the individual performing the maintenance. Maintenance activities,

including the date and individual(s) performing the maintenance activities, shall be

documented.

(2) Each manufacturer shall conduct periodic inspections in accordance with established

procedures to ensure adherence to applicable equipment maintenance schedules. The

inspections, including the date and signature of individual(s) conducting the inspections, shall

be documented.

(3) Adjustments. Each manufacturer shall ensure

that any allowable tolerances or inherent limitations are visibly posted on or near equipment

requiring periodic adjustments or are readily available to personnel performing these

adjustments.

(4) Manufacturing material. Each manufacturer shall establish and maintain procedures for use

and removal of manufacturing material to ensure that it is removed from the device or limited

to an amount that does not adversely affect device’s quality. The removal of such

manufacturing material shall be documented.

(h) Automated processes. When computers are used in the production, quality system or data

processing systems, designed personnel shall validate the software according to an established

protocol. The results shall be documented. All software changes shall be made by designated

personnel by means of validation established and approved procedures according to part D(c)

of this part.

2. Special processes

(a) Each manufacturer shall ensure that special processes are:

(1) Validated according to the established protocol, and records shall be made of the results of

validation, including the date of and individual responsible for the validation.

(2) Conducted according to established procedures that describes all processing controls

necessary to ensure conformance to specifications;

(3) Monitored according to established procedures to ensure process parameters are met; and

(4) Performed by qualified, designated individuals.

(b) The individual(s) responsible for the performance of a special process shall record the

completion of the process in the device history record. The record shall include identification

of the process, the date performed, each individual that performed the special process, and

the equipment used.

Part H – Inspection and Testing

1. Inspection and testing

(a) General instructions. Each manufacturer shall establish and maintain the inspection and

testing activities necessary to ensure that specified requirements are met. The results of all

inspections and testing shall be documented.

(b) Receiving inspection and testing. Each manufacturer shall establish and maintain

procedures for the acceptance of components, manufacturing materials and finished devices.

Components, manufacturing materials and finished devices shall not be used or processed

until they have been verified as conforming to specified requirements. Individual designated

by the manufacturer shall accept or refuse incoming components, finished devices and

manufacturing materials. Acceptance and rejection shall be documented.

(c) In-process inspection and testing. Each manufacturer shall establish and maintain

procedures for the inspecting and testing in-process components, finished devices, and

manufacturing materials. Each manufacturer shall establish and maintain procedures for

holding in-process components, finished devices, and manufacturing materials until the

required inspections and tests have been completed or necessary reports have been received

and verified.

(d) Final inspection and testing. Each manufacturer shall establish and maintain procedures for

finished device inspection to ensure each lot or batch meets device specifications. Finished

devices shall be held in quarantine or otherwise

adequately controlled until released by an individual designated by the manufacturer. Finished

devices shall not be released until all the required activities specified in the DMR have been

completed and the associated data and documentation are reviewed to ensure all acceptance

criteria have been met. Release, including the date and signature of the designated individual

responsible for release, shall be documented.

(e) Inspections and test records. Each manufacturer shall and maintain a record of the results

of all tests and inspections required by this part. These records shall include acceptance

criteria, inspections checks performed, results, equipment used and the date and signature of

the individuals conducting the inspection and testing. This record shall be part of the device

history record.

2. Inspection, measuring and test equipment

Each manufacturer shall ensure that all measurement and test equipment, including

mechanical, automated or electronic equipment is suitable for its intended purposes and is

capable of producing valid results. Each manufacturer shall establish and maintain procedures

to ensure that the equipment is routinely calibrated, inspected and checked. Records

documenting these activities shall be maintained.

(a) Calibration. Each manufacturer shall establish and maintain calibration procedures that

include specific directions and limits for accuracy and precision and provisions for remedial

actions when accuracy and precision limits are not met. Calibration shall be performed by

personnel who have the necessary education, training, background, and experience.

(b) Calibration standards. Each manufacturer shall establish and maintain calibration standards

for measurement equipment that are traceable to the National standards. If National

standards are not practical or available, the manufacturer shall use an independent

reproducible standard. If no applicable standard exists, the manufacturer shall establish and

maintain an in-house standard.

(c) Calibration records. Each manufacturer shall ensure that records of calibration dates, the

individual performing each calibration, and the next calibration date are maintained. These

records shall be maintained by individuals designated by the manufacturer and displayed on or

near each piece of equipment or shall be readily available to the personnel using such

equipment and the individuals responsible for calibrating the equipment.

(d) Maintenance. Each manufacturer shall establish and maintain procedures to ensure that

the handling, preservation, and storage of test, inspection, and measuring equipment is such

that their accuracy and fitness-for-use are maintained.

(e) Facilities. Each manufacturer shall protect facilities and inspection, test and measuring

equipment, including both test hardware and test software, from adjustments that would

invalidate calibration.

3. Inspection and tests results

(a) Each manufacturer shall identify inspection and test results of all components,

manufacturing materials, and finished devices. The identification shall be visible, shall indicate

the conformance or nonconformance of these items with respect to acceptance,

manufacturing, packaging, labeling, installation and servicing criteria to ensure that only

components, finished devices and manufacturing materials which have passed the required

inspection and tests are distributed, used and installed.

(b) Each manufacturer shall ensure that records shall identify the individuals responsible for

the release of components, manufacturing materials and finished devices.

Part I – Nonconforming Components and Devices

(a) Control of nonconforming product. Each manufacturer shall establish and maintain

procedures to ensure that components, manufacturing materials, finished devices, and

returned devices that do not conform to specified requirements are not inadvertently used or

installed. The procedures shall provide for the identification, documentation investigation,

segregation and disposition of nonconforming components, manufacturing materials, finished

devices, and returned devices, and for notification of the persons of organizations responsible

for the nonconformance.

(b) Nonconformity review and disposition.

(1) The responsibility for review and the authority for the disposition of nonconforming

components, manufacturing materials, finished devices and returned devices shall be defined.

(2) Each manufacturer shall establish and maintain procedures for the reprocessing, retesting

and renewal of tests for nonconforming components and finished devices, to ensure they

meet their original, or subsequently modified and approved specifications. The procedures

shall be contained or referenced in the device master record. Reprocessed devices or

components shall be clearly identified as reprocessed, and the reprocessing and reinspection

results shall be recorded din the device history record. Reprocessed devices and components

shall be subject to another complete reinspection for any characteristic of the device which

may be adversely affected by such reprocessing. When there is repeated reprocessing of a

device or component a determination of the effect of the reprocessing upon the device or

component shall be made and documented.

Part J – Corrective Action

(a) Each manufacturer shall establish and maintain procedures for:

(1) Analyzing all processes, working operations, concessions, quality audit reports, quality

records, service records, complaints, returned products and other sources of quality data to

identify existing and potential causes of nonconforming components and finished devices or

other quality problems (analysis shall include trend analysis to detect recurring quality

problems);

(2) Investigating the nonconforming with the specifications of any distributed device;

(3) Identifying the actions needed to correct and prevent recurrence of nonconforming

product and other quality problems;

(4) Verifying or validating the adequacy of corrective action to ensure that the corrective

action does not adversely affect the finished device and that the corrective action is effective;

(5) Implementing and recording changes in methods and procedures needed as a result of the

identification of quality problems and corrective action; and

(6) Ensuring that quality problem information is disseminated to those directly responsible for

ensuring quality and is reviewed by the management.

(b) All activities required under this section, and their results, shall be documented.

Part K – Handling, Storage, Distribution, and Installation

1. Handling

Each manufacturer shall establish and maintain procedures to ensure that mixups (changes),

damages, deterioration, or other adverse effects to components, finished devices and

manufacturing materials do not occur during any stage of handling.

2. Storage

(a) Each manufacturer shall establish and maintain procedures for the control of storage areas

of components, manufacturing materials and finished devices, to prevent mixups (changes),

damages, deterioration or other adverse effects prior to distribution or use.

(b) Each manufacturer shall establish and maintain procedures for authorizing receipt from

and dispatch to such designated areas. Any control number or other identification used shall

be legible and clearly visible. When the quality of components or finished devices deteriorates

over time, such devices shall be stored in a manner to facilitate proper stock rotation and their

condition shall be assessed at appropriated intervals. Each manufacturer shall establish and

maintain procedures to ensure that all manufacturing materials, components and obsolete,

rejected, or stored devices are not inadvertently distributed or used.

3. Distribution

(a) Each manufacturer shall establish and maintain procedures to control the distribution of

finished devices to ensure that only those devices approved for release are distributed. When

the device fitness-for-use or quality deteriorates over time, the procedures shall ensure that

the oldest approved devices are distributed first and that expired devices are not distributed.

(b) Each manufacturer shall maintain distribution records which include or make reference to

the location of:

(1) Name and address of consignee;

(2) The identification and quantity of devices shipped, the date shipped; and

(3) Any control number used for traceability.

4. Installation

Each manufacturer shall establish and maintain adequate instructions and procedures for

proper device installation. Instructions and procedures shall include directions for verifying

proper performance of the installation. When the manufacturer or its authorized

representative installs a device, the manufacturer or representative shall verify that the

device( s) will perform as installation. The results of verification shall be recorded. When a

person other than manufacturer or its authorized representative installs a device, the

manufacturer shall ensure that the installation instructions and procedures are distributed

with the devise or otherwise available to the person installing the device.

Part L – Packaging and Labeling Control

1. Device packaging

Each manufacturer shall design and construct device packing and shipping containers to

protect the device from alteration or damage during the customary conditions of processing,

storage, handling and distribution conditions.

2. Device labeling

Each manufacturer shall establish and maintain procedures to maintain labeling integrity and

to prevent labeling mixups.

(a) Labels integrity. Each manufacturer shall ensure that the labels are designed, printed and,

where applicable, applied so as to remain legible and affixed during the customary conditions

of processing, storage, handling, distribution, and use.

(b) Labeling shall not be released for storage or use until a designated individual(s) has

examined the labeling for accuracy including, where applicable, the correct expiration date,

control number, storage instructions, handling instructions, and any additional processing

instructions. The release, including the date and

signature of the individual(s) performing the examination, shall be documented in the DHR.

(c) Labels storage. Each manufacturer shall store and maintain labels in a manner that provides

proper identification and is designed to prevent mixups (changes).

(d) Labels control. Each manufacturer shall control labels and packaging operations to prevent

mixups (change).

3. High risk devices labeling (class III or IV)

Labeling of high risk devices, (class III or IV) shall include a control number.

Part M – Records

1. General requirements

All records shall be legible and shall be stored to minimize deterioration, to prevent loss and

allow easy access. Those records stored in automated data processing systems shall be backed

up. All records required by this part shall be maintained at the manufacturing establishment or

other location that is reasonably accessible to responsible officials of the manufacturer and to

employees appointed by the competent health authority. Such records, including those not

stored at the inspected establishment, shall be made readily available for review and copying

by health authority employees. Unless otherwise specifically indicated, the following general

instructions shall apply to all records required by this part.

(a) Confidentiality. Records deemed confidential by the manufacturer may be marked to

advise competent health authority.

(b) Records retention period. All records required concerning a device shall be retained for a

period of time equivalent to the expected life of the device, but, in no case, for less than two

years from the date of release for commercial distribution by the manufacturer. Photocopies

or any other reproduction of the records required by this part may be used. When reduction

techniques as microfilms are used, reading equipment shall be available.

2. Device master record (DMR)

Each manufacturer shall maintain device master records (DMR’s). Each manufacturer shall

ensure that each DMR is prepared, dated and signed by a responsible individual (s) appointed.

Any alterations in a DMR shall comply with the applicable requirements of part D. DMR for

each kind of product shall include or refer to the following information:

(a) Device specifications including appropriate drawings, composition, formulation, component

specifications, software specifications, and source codes;

(b) Production process specification, production methods, production procedures and

production environmental specifications;

(c) Quality system documents, including comparisons used and results of the validation

protocols;

(d) Packaging and labeling specifications, including methods and processes used; and

(e) Installation, maintenance, and servicing methods and procedures.

3. Device history record.

Each manufacturer shall maintain device history records (DHR's). Each manufacturer shall

establish and maintain procedures to ensure that DHR's for each lot or unit are maintained to

demonstrate that the device is manufactured in accordance with the DMR and the

requirements of this part. The DHR shall be

accessible and maintained by designated individuals. The DHR shall include, or refer to the

following information:

(a) The dates of manufacture;

(b) The quantity manufactured;

(c) The quantity released for distribution;

(d) Labeling;

(f) Any device identification(s) and control number(s) used.

4. Complaint files.

(a) Each manufacturer shall maintain complaint files. Each manufacturer shall establish and

maintain procedures for receiving, reviewing, evaluating, and file complaints. Such procedures

shall ensure that:

(1) All complaints are received, reviewed, evaluated, investigated and filed by a duly assigned

unit;

(2) Oral complaints are documented upon receipt; and

(3) Complaints are evaluated to verify whether an investigation is required. When no

investigation is made, the unit shall maintain a record that includes the reasons no

investigation was made, and the name of the individual responsible for the decision not to

investigate.

(b) Each manufacturer shall review, evaluate and investigate all complaints involving a possible

nonconforming device, labeling or packaging to meet its specifications. Any complaint related

to the death, injury or any safety risk shall be immediately analyzed, evaluated and

investigated by a designated individual, and shall be maintained in a separate portion of the

complaint files. Investigations shall include verification of an actual failure in the performance

or specifications; whether the device was being used for therapy or diagnosis; whether death,

injury or severe diseases were involved; and the relationship, if any, of the device to the

reported incident or adverse event.

(c) When an investigation is made, a record of the investigation shall be maintained by the

formally designated unit identified in paragraph (a) of this section. The record of investigation

shall include:

(1) The name of the device;

(2) The date the complaint was received;

(3) Any device control number(s) used;

(4) The name, address, and phone number of the complainant;

(5) The nature of the complaint;

(6) The results of the investigation;

(d) The results of the investigation shall include:

(1) Any corrective action taken;

(2) The dates of the investigation;

(3) Details of the complaint;

(4) Any reply to the complainant.

(e) When no reply is made to the complaint, the

reason shall be reported.

(f) When the manufacturer's formally designated complaint unit is located at a site separate

from the manufacturing establishment, a copy of the investigated complaint(s) and the

record(s) of investigation shall be forwarded and filed at the manufacturing establishment, on

a specific file for product complaints.

(g) When the formally designated complaint unit is located outside of the country, a copy of all

of each records required under this section shall be maintained in the country. If the

manufacturer has a location in the country where records are regularly kept, the copies

required in this paragraph may be maintained at such location. Otherwise, the copies required

under this paragraph shall be provided to and kept by the agent designated or distributor.

(h) Each manufacturer shall establish and maintain procedures for processing complaints to

ensure that all complaints are processed in a uniform and timely manner. Such procedures

shall include provisions for determining whether the complaint represents an event which is

required to be reported to competent health authority.

Part N – Servicing

Each manufacturer shall establish and maintain procedures to ensure that the finished devices

that are serviced by the manufacturer or its representatives meet specifications. Procedures

for servicing shall include provisions for determining if service requests represent an event

which must be reported to the competent health authority.

(a) Service records. Each manufacturer shall establish and maintain procedures to ensure that

service records are maintained that identify the object to be serviced, including any control

numbers used, the date of service, the service performed, and individual (s) servicing the

device.

(b) Service records evaluation. Each manufacturer shall analyze servicing records according to

Part J of this part; except that when a service report records involve death, serious injury or

safety hazard. In such circumstances, the report shall be considered a complaint and shall be

investigated in accordance with the requirements of Part M-4, of this part.

Part O – Statistic Techniques

(a) Where appropriate, each manufacturer shall establish and maintain procedures for

identifying valid statistical techniques required for verifying the acceptability of process

capability and product characteristics.

(b) Sampling plans shall be written and based on a valid statistical rationale. Each

manufacturer shall establish and maintain procedures to ensure that sampling methods are

adequate for their intended use and regularly reviewed, especially in case of events, such as

nonconforming devices, adverse quality audit reports or complaints.

ANNEX II

VERIFICATION OF COMPLIANCE WITH THE GOOD MANUFACTURING PRACTICES FOR MEDICAL

DEVICES

TABLE OF CONTENTS

1. Application of the Verification Items

2. Verification Items Applicable to Manufacturers

3. Verification Items Applicable to Importers

Attachment A – Verification of Classification’s Items

Attachment B – Inspection Guide

1. APPLICATION OF THE VERIFICATION ITEMS

1. This Inspection Guideline aims at assisting the compliance verification of Good

Manufacturing Practices – GMP of Medical Devices by manufacturers or importers of such

devices.

2. Answers to the requirements (items 2 and 3) in this document will serve as the basis for the

Inspection Guide elaboration (Attachment B), which will provide information so that the

competent health authority may resolve on the issue of constancy/compliance certificate of

the GMP.

3. No submission of the documentation required by the inspector or omission of the required

information shall means the manufacturer or importer does not comply with the GMP

requirements for medical devices.

2. VERIFICATION ITEMS APPLICABLE TO MANUFACTURERS

Part A – GENERAL PROVISIONS: Nonconforming (NC).

Part B – QUALITY SYSTEM REQUIREMENTS

Question Device Class

I II III, IV

B.1 Management Responsibility

B.1.1 Is there a quality policy in the company? RQ RQ RQ

B.1.2 Were employees informed about the goals of this policy?

Are the goals comprehended?

RQ RQ RQ

B.1.3 Is there an organization chart showing the company’s

organizational structure?

R R R

B.1.4 Are there descriptions of functions that define the

authority and responsibility for the design, purchase,

manufacturing, packaging, labeling, storage, installation

and servicing functions?

RQ RQ RQ

B.1.5 Is there a formally appointed administration

representative with authority and responsibility to ensure

that the quality system requirements are established and

maintained according to the requirements of the good

manufacturing practices for medical devices?

R R RQ

B.1.6 Is the quality system performance periodically evaluated

by the executive management?

R RQ RQ

B.1.7 Is evaluation documented? R RQ RQ

B.1.8 Is there a procedure establishing periodicity of such

evaluation?

R RQ RQ

B.1.9 Is the quality system described in a properly disclosed

manual or equivalent document?

R RQ RQ

B.2. Quality Audit

B.2.1 Does the company have internal audit procedures to verify

whether the quality system complies with the

requirements established in the good manufacturing

practices for medical devices?

I R RQ

B.2.2 Are there training records of the quality system internal

auditors?

I R RQ

B.2.3 Are there internal quality audit reports indicating the

nonconformity found out?

I R R

B.2.4 Is the report signed by the responsible individuals of the

audited area?

I R R

B.2.5 Is personnel carrying out internal quality audits

independent of the audited areas?

I R RQ

B.2.6 Are there implementation records of corrective measures

recommended in the internal audit reports?

I R R

B.3. Personnel

B.3.1 Does the company have personnel recruitment and

selection procedures?

R R R

B.3.2 Are individuals trained to appropriately perform tasks

assigned to them?

R R R

B.3.3 Are these trainings recorded? R R R

B.3.4 Are there evidences that individuals were informed about

the nonconformity resulting from the incorrect

performance of their tasks?

R R R

Part C – PROJECT CONTROL

Question Product Class

I II III, IV

C.1 Are there procedures for design development and control? I R RQ

C.2 Are the procedures approved by a responsible individual? R R R

C.3 Is there a declared approval for the design specific

characteristics?

I R RQ

C.4 Are there evidences that the design was evaluated by an

appointed and responsible individual and that

performance is in accordance with the input data?

I R RQ

C.5 Is there a testing certification to verify whether the design

output data is in accordance with the specifications?

I R RQ

C.6 Does the manufacturer maintain procedures to ensure

that the design will be approved by a responsible

individual before being released to production?

I R RQ

C.7 Does the manufacturer maintain a design history record to

confirm it was developed in accordance with approved

I R RQ

requirements?

Part D – DOCUMENTS AND RECORDS CONTROLD

Question Product Class

I II III, IV

D.1 Is there a procedure for documents control? I R R

D.2 Are documents approved by appointed individuals? I R R

D.3 Are documents available in appropriate locations? I R R

D.4 Are documents updated according to the review

procedures?

I R R

D.5 Is there a procedure to remove old documents? I R R

D.6 Does the company maintain documents change and

review procedures?

I R R

D.7 Are there procedures for the distribution and records of

documents identified as controlled documents?

I R R

Part E – PURCHASING CONTROLS

Question Product Class

I II III, IV

E.1 Is there a procedure for the evaluation of suppliers? R RQ RQ

E.2 Are there purchase specifications clearly defining the

requirements to be fulfilled by the supplier?

R RQ RQ

E.3 Does the company maintain a record of approved

suppliers?

I R R

E.4 Are purchase orders approved by responsible individual

(s)?

I R R

E.5 Is such authorization formalized? I R R

Part F – IDENTIFICATION AND TRACEABILITY

Question Product Class

I II III, IV

F.1 Does the company have a procedure to identify the

received manufacturing materials?

R RQ RQ

F.2 Are components and manufacturing materials identified? R RQ RQ

F.3 Is component or manufacturing material identified with a

lot or batch number which allows traceability?

R RQ RQ

F.4 Is the lot or batch number, associated with the finished

product, correspondingly recorded?

I RQ RQ

Part G – IN-PROCESS AND PRODUCTION CONTROL

Question Product Class

I II III, IV

G.1 In-process and Production Controls

G.1.1 Is there a procedure for the release of finished devices? R RQ RQ

G.1.2 Are production procedures available at the usage or

assigned locations?

R R R

G.1.3 Are there controls to prevent mixing lots or batches of

components, manufacturing materials or finished devices?

R RQ ID

G.1.4 Is there a production specification? R RQ ID

G.1.5 Was this specification prepared and reviewed by

designated individual(s)?

R R R

G.1.6 Is there a procedure to modify specifications with a

declared responsibility indication?

R R RQ

G.1.7 Are there procedures for cleaning production areas? I R RQ

G.1.8 Is cleaning of the production areas compatible with the

type of product manufactured?

R RQ RQ

G.1.9 Are there evidences that employees do not eat, drink or

smoke in areas that may affect the product?

I R RQ

G.1.10 Is there a documented program to kill insects and rodents? R R RQ

G.1.11 Are there evidences that such program is in force? R R RQ

G.1.12 Do employees wear appropriate uniform and shoes for the

work performed?

R RQ RQ

G.1.13 Are there adequate restrooms and dressing rooms for

employees?

RQ RQ RQ

G.1.14 Are adequate restrooms and dressing rooms acceptably

neat and clean?

RQ RQ RQ

G.1.15 Is there a clear definition of the allowed pesticides and the

areas in which they can be applied?

R R RQ

G.1.16 Are there evidences of regular garbage collection in the

production areas?

R R RQ

G.1.17 Is there a documented program for the cleaning and

maintenance of machines and equipment?

I R RQ

Part G – IN-PROCESS AND PRODUCTION CONTROLS

Question Product Class

I II III, IV

G.2 Special Processes

G.2.1 Are there established validation protocols for special

processes?

R RQ RQ

G.2.2 Are there records referring to the performance of special

manufacturing processes?

R RQ RQ

G.2.3 Are there evidences that such records are evaluated by a

responsible and qualified individual?

R RQ RQ

Part H – INSPECTION AND TESTS

Question Product Class

I II III, IV

H.1 Inspection and Tests

H.1.1 Are there inspection procedures and, when applicable,

tests of received components and manufacturing materials

in order to ensure specified requirements were fulfilled?

R RQ RQ

H.1.2 Are there inspection reports confirming that the received

components and manufacturing materials were inspected

before being transferred to production and that they

comply with the specifications?

R RQ RQ

H.1.3 When applicable, are tests made during the manufacturing

process in order to ensure compliance with the

specifications?

R RQ RQ

H.1.4 Are results of such tests recorded? R RQ RQ

H.1.5 Are results of such tests evaluated and approved

designated and qualified individuals?

R RQ RQ

H.1.6 Are there procedures to retain components and

manufacturing materials during the process until the

required inspections, tests and approvals have been

completed?

R RQ RQ

H.1.7 Are there evidences that such procedures are met? R RQ RQ

H.1.8 Does the company maintain procedures for the inspection

and test of finished devices assuring that a lot or batch

complies with the specifications?

R RQ ID

H.1.9 Are finished devices identified and stored in a certain area

until the approval final tests are completed?

R RQ ID

H.1.10 Are there evidences that the finished devices transferred

to the shipment department meet final tests, that

transference is made by responsible individual and that

they comply with the requirements provided for in the

device master record (DMR)?

R RQ ID

H.1.11 Is transference of finished devices associated with the

corresponding lots or batches numbers?

R RQ ID

Part H – INSPECTION AND TESTS

Question Product Class

I II III, IV

H.2 Inspection, Measuring and Testing Equipment

H.2.1 Is there a documented program for instruments calibration

and gauging?

R RQ ID

H.2.2 Are inspection, measuring and testing instruments

identified, indicating they are gauged or calibrated?

R RQ ID

H.2.3 Are there procedures to ensure that non-calibrated or

gauged instruments are not installed and used?

R RQ ID

H.2.4 In case no domestic standards are provided, do gauging

and calibration refer to in-house, reliable and reproducible

standards?

R RQ RQ

H.2.5 Are there records confirming reliability of such standards? R RQ RQ

H.3 Result of the Inspection and Tests

H.3.1 Is the result of components, manufacturing materials and

finished devices inspection and tests identified?

R RQ RQ

H.3.2 Are there procedures to ensure that only components,

manufacturing materials and finished devices which meet

inspections and tests are released?

R RQ RQ

H.3.3 Do inspections and tests records identify the individuals

responsible for such release?

R RQ RQ

Part I – NONCONFORMING COMPONENTS AND PRODUCTS

Question Product Class

I II III, IV

I.1 Are there procedures to ensure that nonconforming

components, manufacturing materials, finished or

returned devices are not in use?

R RQ ID

I.2 Are nonconforming manufacturing materials, components,

finished or returned devices clearly identified and

separated?

R RQ ID

I.3 Are there individuals responsible for deciding about

separation and release of materials, components and

finished or returned devices?

R RQ RQ

Part J – CORRECTIVE ACTION

Question Product Class

I II III, IV

J.1 Are there procedures to investigate the reasons of the I R RQ

quality system nonconformity?

J.2 Are corrective measures resulting from nonconformity

investigations documented and implemented?

I R RQ

J.3 Is responsibility and authority to decide about the

evaluation, implementation and monitoring of approved

corrective measures clearly defined?

I R RQ

Part K – HANDLING, STORAGE, DISTRIBUTION AND INSTALLATION

Question Product Class

I II III, IV

K.1 Handling, Storage and Distribution

K.1.1 Does the company maintain procedures for handling

finished devices?

R RQ ID

K.1.2 Are finished devices stored as defined in the procedures? R RQ ID

K.1.3 Are damaged or expired products separated to prevent

inadvertent distribution in the market?

RQ ID ID

K.1.4 Is such separation recorded? RQ RQ RQ

K.1.5 Does the company maintain procedures to withdraw such

devices from the storage area?

RQ RQ RQ

K.1.6 Are devices distributed to market recorded permitting to

identify the addressee name and address, distributed

amounts and control number or manufacturing lot or

batch number, thus allowing traceability?

I RQ ID

K.1.7 Is the storage area under proper hygiene and cleaning

conditions to prevent finished device being damaged and

contaminated?

RQ RQ RQ

K.2 Equipment Installation

K.2.1 Are there instructions and procedures for the products

correct installation?

RQ RQ RQ

K.2.2 Does the company warrant the properly installed product

works in accordance with the specifications?

RQ RQ RQ

K.2.3 When applicable, is installation of each product recorded? RQ RQ RQ

Part L – PACKAGING AND LABELING CONTROL

Question Product Class

I II III, IV

L.1 Are there controls confirming the packages and labels

comply with the specifications?

R R R

L.2 When applicable, are there procedures for products

labeling?

R R R

L.3 When applicable, are labels inspected, approved and

released for stock or use by a designated and qualified

individual?

R R R

L.4 When applicable, does the company provide an area

intended to store labels?

R R R

Part M – QUALITY SYSTEM RECORDS

Question Product Class

I II III, IV

M.1 General Requirements

M.1.1 Are there procedures for filing document records related

to the quality system?

R RQ RQ

M.1.2 Are records retained for the term established by the good

manufacturing practices for medical devices?

R RQ RQ

M.2 Device Master Record and Device History Record

M.2.1 Does the manufacturer maintain a device master record

(DMR) with the requirements defined by the good

manufacturing practices for medical products?

R RQ RQ

M.2.2 Does the manufacturer maintain a device history record to

confirm that the lot or batch was manufactured in

accordance with the DMR provisions?

R RQ RQ

M.3 Complaints File

M.3.1 Are there procedures for managing customer complaints? R RQ RQ

M.3.2 Are complaints recorded in accordance with the good

manufacturing practices requirements for medical

devices?

R RQ RQ

M.3.3 When applicable, are customer complaints evaluated and

investigated? Are corrective measures taken to prevent

recurrences?

R RQ RQ

M.3.4 Are investigations documented? R RQ RQ

M.3.5 Are there records confirming that the approved corrective

measures were implemented?

R RQ RQ

Part N – SERVICING

Question Product Class

I II III, IV

N.1 Does the manufacturer establish and maintain servicing

procedures?

R R RQ

N.2 Are there records of servicing provided to each product? R R RQ

N.3 Are such records in compliance with the good R R RQ

manufacturing practices requirements for medical

devices?

Part O – STATISTIC TECHNIQUES

Question Product Class

I II III, IV

O.1 Are sampling plans adopted by manufacturer formally

written?

R RQ RQ

O.2 Are there procedures for the periodical review of sampling

plans aiming at verifying statistic techniques compliance

with the intended result?

I R RQ

O.3 Is there responsible and qualified individual(s) to review

and suggest appropriate statistic techniques?

I R R

ANNEX A

Classification of the Inspection Guide Items

1. The inspection guide items shall be classified as follows:

- INDISPENSABLE

- REQUIRED

- RECOMMENDABLE

- INFORMATIVE

- NONCONFORMING

2. Corresponding definitions and symbology are:

- INDISPENSABLE (ID)

Means the indispensable item that, for being part of the Good Manufacturing Practices – GMP

requirements, may critically affect the quality of a device and/or safety of employees, as well

as the items corresponding to legal-administrative requirements.

- REQUIRED (RQ)

Means a required item, the noncompliance of which may significantly affect the quality of a

device and/or employees safety.

- RECOMMENDABLE (R)

Means a recommendable item, the noncompliance of which may insignificantly affect the

quality of a device and/or employees safety.

- INFORMATIVE (I)

Means an informative item that expresses descriptive and/or supplementary information.

- NONCONFORMING (NC)

Not considered means an item that shall not be considered in the inspection arranged.

3. Classification of the verification items is applicable to:

- medical devices manufacturers; and

- medical devices importers.

4. Classification of verification items shall be the base on which the inspector will inform to the

competent health authority, in the Inspection Guide (Attachment B), the manufacturer or

importer compliance with the GMP requirements and necessary corrective measures.

5. Symbology of the items Classification Tables hereof adopts the classification of devices in

risk classes defined by the Sanitary Surveillance National Department – “ANIVSA” regulation:

- Class I – Low risk;

- Class II – Medium low risk;

- Class III – Medium high risk;

- Class IV – High risk.

ANNEX B

Inspection Report

The Inspection Report shall contain:

1. corporate name;

2. inspector(s) name(s);

3. inspection reason and/or inspection order number;

4. name, title and professional background of interviewed persons;

5. instructions or recommendations of the inspector(s) to the company;

6. remarks made during the inspection and operational procedures description;

7. deadline recommended by the inspector to the competent health authority to implement

corrective measures, if required;

8. comments of the person in charge of the company concerning inspector(s) remarks;

9. original Report conclusion and corresponding copies, one copy being retained by the

company.