MEDICAL DEVICES

DEFINATION

D & C Act: Instrument intended for internal or external use in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals, as may be specified from time to time by the Central Government by notification in the Official Gazette, after consultation with the Board.

As per USFDA - “An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them, intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of it's primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes."

• By MDD 93/42Medical device means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, with or without software to be used specifically for diagnostic and/or therapeutic purposes, to be used for human beings for the purpose of:

– Diagnosis, prevention, monitoring, treatment or alleviation of disease, ( e.g. Urinary catheter)

– Diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap, ( e.g. Bone cement)

– Investigation, replacement or modification of the anatomy or of a physiological process ( e.g. Hip replacement)

– Control of conception ( e.g. Condoms) 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.

DEFINATION Cont….

By USFDAClass-I (Low Risk):Elastic bandages , Examination Glove, Adult Incontinence Pad

Class –II (Medium Risk): Catheter Cannula, Dialyzer , Piston syringe , Needle, Infusion Pumps, Bone fixation screw, Blood pressure Kit

Class-III (High risk): Pacemakers, Dental Lasers, Heart Valves.

CLASSIFICTIONMedical Devices are classified as per their risk level and intended use.

By CDSCO (IMRDA) & MDD- Risk Based classification

Class A (Class-I)– Devices involving low risk levels (Thermometer)

Class B (Class-II a)– devices involving low to medium risk (Hypodermic Needle)

Class C (Class-II b)– Devices involving moderate to high risk (Lung ventilator)

Class D (Class-III)– Devices involving high risk. (Heart valve, implantable device)

Registration of Medical Devices – UNITED STATES

FDA ‘Approval Process’ by Class of Device

Class-1 Class-2 Class-3

No FDA approval needed*Must register device &

company on FDA website.

FDA clearance required.Typically via 510 (K)

Premarket notification submission.

FDA approval required.Typically via Premarket (PMA) approval process

Approval of Class-3 Devices is complicated and involves clinical trials.Less than 10% of devices are considered Class-3 by the FDA.

* Most Class-1 devices are 510 (K) Exempt

How to determine classification?

Go to www.fd.gov./medicaldevices and search for “product classification” using their search box. This will lead you to the product classification Database.

Note: You will also see a link to device classification near the bottom of this page.

Research devices using FDA websiteUse the database to search for devices similar to your device, called

predicted device

TIP: Use the most basic description of your devices to start your search. The FDA data base uses exact searched so try both singular and plural searches. Use the search button & not go to quick search.

Review the various product description

TIP: Click on the name of devices that seems similar to your product and start reading about them

Determining your path to Compliance

TIP: The regulation number contains a link to a detailed description of the device.

Regulation number is very important

TIP: Read product description very carefully. Find the product most similar to yours.

Once you have determine classification…

Class-1 Class-2 Class-3

Register product using the FDA .Gov website.

Proper product code will be required.

Prepare a 510 (k) application. Some products

require clinical data or product testing.

Develop clinical trials protocols, get approved by

FDA, then prepare & submit premarket approval (PMA )to

FDA.

Length of the approval process

Less than one month.You self registered product& company online. Pay fee

FDA reviews most 510 (k) application with in 90 days. Entire process requires 4-10

months, depends on how closely your product

matches the predicate device

36 months or more, depending o n extent of

clinical trials and additional FDA information request.

FDA takes 180 days to review PMA submission.

Length for FDA review often depends on the quality of your submission! Don’t forget…..

 Premarket Notification - also called PMN or 510(k).

• Class I, II, and III device intended for human use, for which a Premarket Approval

(PMA) is not required, must submit a 510(k) to FDA unless the device is exempt from

510(k) requirements .

•Device manufacturers must notify FDA of their intent to market a medical device at

least 90 days in advance.

•Submitters must compare their device to one or more similar legally marketed

devices and make and support their substantial equivalency claims.

•This allows FDA to determine whether the device is equivalent to a device already

placed into one of the three classification categories

•Before marketing a device, each submitter must receive an order, in the form of a

letter, from FDA which finds the device to be substantially equivalent (SE) and states

that the device can be marketed in the U.S. This order "clears" the device for

commercial distribution.

Device must be registered on FDA. Gov website

Class-1 Class-2 Class-3

To registered you will need:Proof of Payment.

Correct FDA product Code

To registered you will need:Proof of Payment

510 (K) number issued by FDA

To registered you will need:Proof of Payment

PMA number issued by FDA

FDA will issue a 510 (k) number or PMA number. These numbers are required to proceed with final registration step on FDA website.

Class-1 Class-2 Class-3

Most Manufacturers must comply with the FDAQuality System Regulation (21 CFR part 820).

This is also known as good manufacturing practice (GMP).

Companies that outsource manufacturing must still comply. Supplier too!

FDA does not recognize ISO 13485 or ISO 9001 and does not certify quality system.Instead FDA conducts Random Inspection for compliance with 21 CFR 820.

They do inspect class-3 device Manufacturer prior to PMA approval

FDA inspection can happen any time after online registration .

Manufacturers requires a quality system comply with 21 CFR part 820

•The Quality System Regulation (QS Reg)Effective on June 1, 1997 for medical devices.•ISO 13485: 2003 and 21 CFR Part 820 are harmonized; Each may have additional requirements but they do not conflict with one another.

It contains:•Subpart A—General Provisions•Subpart B—Quality System Requirements•Subpart C—Design Controls•Subpart D—Document Controls•Subpart E—Purchasing Controls•Subpart F—Identification and Traceability•Subpart G—Production and Process Controls•Subpart H—Acceptance Activities•Subpart I—Nonconforming Product•Subpart J—Corrective and Preventive Action•Subpart K—Labeling and Packaging Control•Subpart L—Handling, Storage, Distribution, and Installation•Subpart M—Records•Subpart N—Servicing•Subpart O—Statistical Techniques

21 CFR Part 820

Medical Device Approval In Europe (CE Certification)

Medical Devices (MDD) 93/42/EECCovers the bulk of medical devices marketed in the EU

Examples: orthopedic implants, heart valves, medical software

In Vitro Diagnostics (IVDD) 98/79/EC Covers devices used for the examination of specimens taken from the human body

Examples: pregnancy self-testing strips, blood glucose self-testing strips

Active Implantable Medical Devices (AIMDD) 90/385/EEC Covers devices that require external power sources in order to function properly

Examples: pacemakers, implantable defibrillators

EU Directives Impacting Medical Devices

•Manufacturers and Subcontractors

•Competent Authorities

•Notified Bodies

•Authorized Representatives

•Distributors

Key Players in the CE Marking Process

Competent Authorities

Competent Authorities are entities enforcing Medical Device Directives at the national level in each EU member state.

EU member states and their Competent Authorities each have their own interpretations of how Directives should be carried out. Manufacturers seeking to sell in more than one EU member state should take this into account

Overview of the European Union

•27 member states plus European Free Trade Association members (Norway, Switzerland, Iceland and Liechtenstein) •Population of more than 500 million people •23 languages

Notified Bodies

Notified Bodies are authorized to audit manufacturers’ quality systems and test /review devices for compliance with applicable EU Directives and standards.

Notified Body responsibilities include:

•Advising on device classification and Conformity Assessment routes

•Pre-assessment of devices

•Product and quality system evaluation

•Concluding and evaluating manufacturers’ Corrective Actions

•Issuance of certifications

•Maintaining programmed surveillance of devices in the EU

Authorized Representative

Required for any firm without a location in the EU.

Authorized Representatives’ responsibilities may include: •Liaising between manufacturers and Competent Authorities

•Listing their names on clients’ device labels and packaging

•Notifying Competent Authorities of manufacturers’ and devices’ names

•Keeping Technical Files/Design Dossiers available for review by Competent Authorities

•Participating in vigilance/post-market surveillance procedures

Basic Steps to Compliance in the EU

1. Identify Directives and Regulations appropriate for your device.

2. Classify your device according to MDD Annex IX

3. Implement Quality System in compliance with ISO 13485

4. Prepare Technical File or Design Dossier demonstrating compliance with MDD 93/42/EEC.

5. Appoint your Authorized Representative.

6. Have Notified Body audit your Quality System and Technical File or Design Dossier

7. Register your device with Competent Authorities if necessary.

8. Prepare Declaration of Conformity and affix CE Marking to your device

Step One: Classification/MDD Determination First, determine which Medical Device Directive (MDD, AIMDD or IVDD) applies to

your device. Then determine device classification using Annex IX of MDD 93/42/EEC.

How Classification is Determined

Classification Considerations MDD 93/42/EEC Annex IX contains 18 rules for medical device classification based on factors including the following:

•Device’s intended use

•Active versus non-active functionality

•Device’s duration of contact with patient

•Degree of invasiveness

•Part of body contacted by device

•Special situations

Degree of Invasiveness Criteria•Application to body surface versus an orifice •Surgically invasive or non-invasive •Implantable

Duration of Contact Criteria •Less than 60 minutes = Transient •Less than 30 days = Short-term

•More than 30 days = Long-term Determining your device’s duration of contact and degree of invasiveness will help determine how to classify the device

Step Two

Quality System Manufacturers of Class I sterile/measuring, IIa, IIb and III devices must implement quality management systems (QMS) (in compliance with Annex II or V of the MDD).

Most manufacturers meet this requirement using ISO 13485.

Requirement of ISO 13485 (Quality System Requirements)

Phase I: Quality system preparation and development

Phase II: ImplementationTraining, internal audit, CAPA

Phase III: RegistrationRegistration audit by notified bodyFinal ISO 13485 certification

Step ThreeTechnical File/Design Dossier Preparation

Technical File Components

Technical File Components

Clinical Data Requirements

EU regulators have increased their requirements for clinical data even for Class I medical devices in recent years. •In many cases, manufacturers must submit Clinical Evaluation Summary Reports that verify the safety and performance of their products along with Technical Files or Design Dossiers

Manufacturers with no offices in the EU must appoint Authorized Representatives (EC REPs) to interact with regulators on their behalf.

EC REP Responsibilities•Registering your device with Competent Authorities before commercialization •Serving as primary point of contact with all EU Competent Authorities •Keeping a current copy of your Technical File/Design Dossier available for inspections by Competent Authorities •Authorizing you to place EC REP name and address on your device labels, packaging and instructions for use •Handling Incident and Field Safety Corrective Action (FSCA) reporting to Competent Authorities .•Representing you before the European Commission in the event that your product is withdrawn in a member state •Protecting the confidentiality of your product information •Maintaining reports on clinical evaluation data for review by Competent Authorities •Communicating with Competent Authorities on serious device incidents .

Step Four Authorized Representation

Device manufacturers must register with the Competent Authority of the country where their EC REPs are based.

Step Five Notified Body Audit

Step Six:Registration with Competent Authorities

Step Seven:Declaration of Conformity and CE Marking

In order to complete the CE

Marking process, all

manufacturers must prepare a

Declaration of Conformity stating

their device is in compliance with

all applicable Directives. Upon

completion of your Declaration of

Conformity, you may affix CE

Marking to your product.

Labeling and Language Requirements

EU member states MAY REQUIRE labeling information be made available in their local languages or another European Community language to patients and users in accordance with Annex I, point 13 of the MDD.

Post-Market Surveillance (PMS) and Vigilance •PMS required for all medical devices sold in the EU •Manufacturers are required to develop proactive plans for PMS •PMS plans should include reviews of market and field data, complaints and corrective actions •Systematic records of PMS findings must be kept

Import Registration of Medical devices in India under the provisions of the Drugs & Cosmetic Act 1940 & Rules 1945.

India currently imports 70 per cent of its medical devices

At the federal (central or union) government level in India, medical device are

regulated by the Central Drug Standards Control Organization (CDSCO) under the

Ministry of Health and Family Welfare.

No regulations for medical devices in place prior to 2005.

The registration process for medical devices in India remains fluid, but regulators are

taking steps to develop a more formalized over sight policy.

The import, manufacturing ,distribution and sale of medical devices in India are

overseen by the Drugs and Cosmetics Act(1940) and Rules(1945).

22 Nos. medical devices are currently “notified” under the Drugs & Cosmetics Act.

Controls and inspections are carried out by the CDSCO, state drug controllers and

central/state laboratories.

Non notified devices do not require CDSCO registration, and may be imported into

India according to formal customs rules.

Regulation for import medical devices•Foreign and Indian companies will have to apply for permission to import medical devices in India.•Both manufacturer and third party(agent) will have to register with CDSCO.•Indian importer or agent –obtain ‘no objection certificate’.•If the medical device is already approved by USFDA or CE -> Device registration in India will be trouble free.

For the import of medical devices in India, Registration Certificate in Form 41 and Import License in Form 10 are required as per provisions of the Drugs & Cosmetic Act & Rules.Requirements of Import License (Form 10): (2-3 months)Covering LetterSelf-attested copy of authorization letterForm-8Form-9Notarized copy of Wholesale Licence or Manufacturing Licence of the Indian AgentCopy of Registration Certificate in form-41Documents as stated in Registration Certificate (In case of conditional certificate)Notarized Labels of the device as per Rule 109 A of Drugs & Cosmetics Rules).

Indian FDA: http://www.cdsco.nic.in/forms/Default.aspxMedical Device: http://cdsco.nic.in/Medical_div/medical_device_division.htm

Registration of Medical Devices in IndiaRequirements of Registration (Form 41):I. From ManufacturerA. Legal Documents1. Power of attorney2. Schedule D-I3. Schedule D-II (Device Master file)B. Regulatory Certificates1. Plant Registration Certificate2. Manufacturing & Marketing License3. Free Sale Certificate/ Certificate of Foreign Govt. from the country of origin4. Free Sale Certificate from anyone of the GHTF countries5. US FDA clearance/approval6. Certificate of Foreign Government7. EU medical device directive (CE Certificate)8. CE Declaration of Conformity9. CE Design Certificate10. CE full quality Assurance11. Approval Certificates in any other country12. ISO/EN-13485 Certification if any for the manufacturing facility13. List of countries where the device is being sold14. Domestic Price List15. List of Quantities Sold of Products Sold in Various Countries for last 3 yrs (approximate)

E. PMS -DOSSIER1. Post Market Surveillance files containing the following details2. Procedures for distribution of records3. Complaint handling4. Adverse incident reporting5. Procedure for product recall6. PMS Data & Corrective Actions TakenF. Labels as per Rule 109 A of D&C actG. Product Insert/IFUH. Printed Company Profile & Catalogues

•A Registration Certificate, unless, it is sooner suspended or cancelled, shall be valid for a period of three years from the date of its issue.

•The requirements for Re-registration of Devices are remains same as fresh Registration requirements except requirement of hard copy of Plant Master File (PMF) and Device Master File (DMF) provided there are no changes in the PMF and DMF, However soft copy of PMF and DMF in the form of compact disc shall be provided along with the application.

Changes happening to regulation of medical devices in India

The Indian health ministry is planning significant changes to its regulatory approach for medical devices. Revisions will include:

• Defining and regulating medical devices separately from drugs• Bringing all medical devices under regulation in India ( more than 3000 nos.)• Establishing a risk-based device classification system• Establishing clinical trial protocols/ methodologies • Setting up conformity assessment procedures• Increasing staff and resources at the CDSCO• Setting up medical device testing labs (Near Gandhinagar, Ahmedabad)• Commencement of materovigilance program• Self certification of medical devices (ISO 13485 Certification)• The State Drug Licensing Authority called as Food and Drug Administration (“FDA”), recently

issued a letter to the DCGI and the National Pharmaceutical Pricing Authority making a case for bringing medical devices under price control. The Drug Price Control Order, 2013 (“DPCO”) which provides a framework for controlling the prices of drugs .

• Medical Devices manufacturing hubs/ parks are planned with huge tax benefits & single window clearance Medical park is inaugurated at Gujarat & second one in Tamilnadu.

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