The Regulation Of Medical Device In China
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Transcript of The Regulation Of Medical Device In China
State Food and Drug Administration,China 1
The Regulation of Medical Devices in China
Wang LanmingDepartment of Medical Devices
State Food and Drug Administration, ChinaApril 13-14, 2005
in Washington & Boston, U.S.A
State Food and Drug Administration,China 2
OVERVIEW
Administrative Organizations and Regulations
Medical Device Standardization
Supervision over Medical Device Manufacturing
Medical Device Vigilance
State Food and Drug Administration,China 3
1. Administrative Organizations and Regulations
State Food and Drug Administration,China 4
About SFDA
State Food and Drug Administration (SFDA)
founded in 2003, directly led by the State Council of P. R. China;
Local Agencies: 31 provincial-, 433 municipality-,1,936 county- level agencies (2,401 total);
Technical Organizations: 16 state-, 122 provincial-, 373 municipality-, 436 county- level organizations (947 total)
State Food and Drug Administration,China 5
State Council
SFDA
General Office
Dept. of Drug Registration
Dept. of Drug Market Compliance
Dept. of Drug Safety &Inspection
Dept. of Medical Devices
Dept. of Personnel & Education
Dept. of International Cooperation
Dept. of Policy & Regulation
Dept. of Food Safety Supervision
Dept. of Food Safety Coordination
Organizational Structure of SFDA
State Food and Drug Administration,China 6
Department of Medical Devices① Division of Standardization
② Division of Product Registration
③ Division of Safety & Supervision
Department of Drug Market Compliance
State Food and Drug Administration,China 7
SFDA Technical OrganizationsMedical Device Technical Evaluation Center;
National Center for Adverse Drug Reactions
Monitoring;
Medical Device Quality Testing Centers;
The Technical Committee for Medical Device
Standardization
State Food and Drug Administration,China 8
MD Regulatory System in China
1.Regulation (issued by the State Council)
2. SFDA Orders
3.SFDA Documents
State Food and Drug Administration,China 9
MD Regulations
1.RegulationRegulation for the Supervision and Administration of Medical Devices
State Council Order No.276 (Jan 4, 2000)
come into force as of April 1, 2000.
State Food and Drug Administration,China 10
2. SFDA Orders
(1) Provisions on Classification of Medical Devices (No.15)
(2) Provisions on Medical Device Registration (No.16)
(3) Provisions on New Medical Device Approval (Interim) (No.17)
(4) Provisions on Medical Device Manufacturing Supervision &
Administration (No.12)
(5) Provisions on Medical Device Distributor Licensure
Administration (No.15)
State Food and Drug Administration,China 11
(6) Provisions on Medical Device Manufacturing Enterprise Quality
System Inspection (No.22)
(7) Provisions on Single Use Sterile Medical Device Supervision &
Administration (Interim) (No.24)
(8) Provisions on Instruction for Use and Labeling of Medical
Devices (No.10)
(9) Provisions on Medical Device Standardization (No.31)
(10) Provisions on Clinical Trial of Medical Devices (No.5)
State Food and Drug Administration,China 12
3.SFDA Documents (Examples)
Product Classification Catalog of Medical Devices
Provisions on Cornea Contact Lens Distribution Supervision &
Administration
Detailed rules on Single Use Sterile Medical Device (syringe,
infusion) Manufacturing
Provisions on the Daily Supervision for Medical Device
Manufacturing Enterprises (Interim)
State Food and Drug Administration,China 13
Provisions on Qualification Certification of Medical Device Testing
Center (Interim)
Detailed Rules on Medical Device Manufacturer Licensing Practice
Detailed Rules on Class I Medical Device Registration Licensing
Practice
Detailed Rules on Class II Medical Device Registration Licensing
Practice
Detailed Rules on Class III & Imported Medical Device Registration
Licensing Practice
………
State Food and Drug Administration,China 14
Medical Device Registration
(presented by Mr. Chang Yongheng)
Medical Device Standardization
Supervision over Medical Device Manufacturing
Medical Device Vigilance
State Food and Drug Administration,China 15
2. Medical Device Standardization
State Food and Drug Administration,China 16
Current Regulations
Regulation for the Supervision and Administration of
Medical Devices (State Council Order No. 276)
Provisions on Medical Device Standardization
Provisions on Classification of Medical Devices
Product Classification Catalog of Medical Devices
Provisions on Qualification Certification of Medical Device
Testing Centers (Interim) ………
State Food and Drug Administration,China 17
"Medical device" Definition
Any instrument, apparatus, appliance, material, or other article whether used alone or in combination, including the software necessary for its proper application. It does not achieve its principal action in or on the human body by means of pharmacology, immunology or metabolism, but which may be assisted in its function by such means; the use of which is to achieve the following intended objectives:
1. Diagnosis, prevention, monitoring, treatment or alleviation of disease;
2. Diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap conditions;
3. Investigation, replacement or modification for anatomy or a physiological process;
4. Control of conception.
State Food and Drug Administration,China 18
MD Classification
Class I Medical Devices: safety and effectiveness can
be ensured through routine administration;
Class II Medical Devices: further control is required to
ensure their safety and effectiveness;
Class III Medical Devices: implanted into the human
body, or used for life support or sustenance, or pose
potential risk to the human body and thus must be strictly
controlled in respect to safety and effectiveness.
State Food and Drug Administration,China 19
Medical Device Standards
Classification:
Basic standard, Safety standard, Product standard;
Compulsory standard (GB, YY) , Recommended standard
(GB/T, YY/T);
National standard (GB, GB/T), SFDA standard (YY, YY/T),
Registration product standard (ZCB)
State Food and Drug Administration,China 20
EXAMPLESGB9706.1-1995 idt IEC60601.1:1988
Medical Electrical Equipment Part 1. General requirements for safety
GB/T16886-2001 idt ISO10993:1997
Biological evaluation of medical devices
YY/T0316-2003 idt ISO14971:2000
Medical devices-Application of risk management to medical devices
YY/T0287-2003 idt ISO13485:2003
Medical devices-Quality Management Systems-Requirements for
Regulatory Purposes
State Food and Drug Administration,China 21
• Formulation of National & SFDA standardsnational standards: 134;
SFDA standards: 560
2004: national standards: 23;
SFDA standards: 68
(including NEW & REVISED)
Progress in Medical Device Standardization
State Food and Drug Administration,China 22
• Qualification certification for testing centers
2004: 27 testing centers certified;
other 7 inspections completed
State Food and Drug Administration,China 23
3. Supervision over Medical Device Manufacturing
State Food and Drug Administration,China 24
Current Regulations
Regulation for the Supervision and Administration of
Medical Devices (State Council Order No.276)
Provisions on Medical Device Manufacturing Supervision
& Administration
Provisions on Medical Device Manufacturing Enterprise
Quality System Inspection
Provisions on the Daily Supervision for MD Manufacturing
Enterprises (Interim) ………
State Food and Drug Administration,China 25
Medical Device Manufacturing
Enterprise Licensing & Informing
Manufacturer of Class II, III product;
Manufacturer of Class I II III product
State Food and Drug Administration,China 26
General Conditions for MD Enterprise Operation
(1) Qualified technical staff;
(2) Manufacturing location and environment;
(3) Manufacturing equipment;
(4) Product quality testing capability (personnel,
equipment)
State Food and Drug Administration,China 27
Special Requirements for Enterprises of Class II & III Products(1) Qualification of the heads responsible for production, quality and technology;
(2) Percentage of the technical staff in the all employees;
(3) Suitable production equipments, locations & environments for production and storage;
(4) Suitable quality testing laboratory and capability;
(5) Keep all related regulations and technical standards
State Food and Drug Administration,China 28
Additional Requirements for Enterprises of Class III Products
(1) No less than 2 internal auditors of Quality System;
(2) No less than 2 technical staff with medium-graded
technical rank and above
State Food and Drug Administration,China 29
Daily Supervision for Manufacturers
Provisions on the Daily Supervision for MD
Manufacturing Enterprises (Interim)
Key-Supervised Products and Manufacturers
country level-: 607 (30 products)
provincial level-: 997
State Food and Drug Administration,China 30
Requirements for Quality System
Detailed Rules on Medical Device Manufacturer
Licensing Practice
Provisions on Medical Device Manufacturing Enterprise
Quality System Inspection
Detailed Rules on the Production of some KEY Products
YY/T 0287 idt ISO 13485 Quality System Certification
State Food and Drug Administration,China 31
Principles on drafting GMP regulation
1.Reference to the Standard YY/T0287- 2003 idtISO 13485: 2003;
2.Integrated with the requirements in Chinese MD regulations and relevant standards;
3.Cover all the processes including design, production, installation, sales and service, for the Class II & III manufacturer;
4. As regulatory requirements --- compulsory
State Food and Drug Administration,China 32
Framework of GMP Regulation
General rules
Implementation guidelines (by category)
Detailed implementation rules on product
manufacturing (by product)
State Food and Drug Administration,China 33
Working Progress◊ Sterile device◊ Implantable device
Working Plan
Responsibility for GMPSFDA
Local agencies in provincial and below
State Food and Drug Administration,China 34
4. Medical Device Vigilance
----Monitoring and Reevaluation
State Food and Drug Administration,China 35
Current Regulations
Regulation for the Supervision and Administration of Medical Devices (State Council Order No. 276)
Provisions on Medical Device Registration
Provisions on Medical Device Manufacturing Supervision & Administration
Provisions on Medical Device Distributor Licensure Administration
Provisions on Single Use Sterile Medical Device Supervision & Administration (Interim) ………
State Food and Drug Administration,China 36
Regulatory System
Regulation for the Supervision and Administration of Medical Devices (State Council Order No.276)
Provisions on Medical Device Registration (SFDA Order No.16)
Progress in Medical Device Vigilance
State Food and Drug Administration,China 37
Provisions on Medical Device Manufacturing Supervision &
Administration (SFDA Order No.12)
Provisions on Medical Device Distributor Licensure
Administration (SFDA Order No.15)
Provisions on Single Use Sterile Medical Device Supervision &
Administration (Interim) (SDA Order No.24)
State Food and Drug Administration,China 38
• Technical Supporting Organizations
State Food and Drug Administration,China 39
Time: Dec 1, 2002 to June 30, 2004Medical Devices:
Cardiovascular stent;Cornea contact len (Orthokeratology len);Cardiac value;Polyacrylamide hydrogel; Orthopaedic implant
• Pilot Program (2002.12-2004.06)
State Food and Drug Administration,China 40
Participants: Beijing, Shanghai, Guangdong province
plus other 5 hospitals and 8 manufactures
Totally:50 manufactures; 232 distributors;
268 hospitals were involved
State Food and Drug Administration,China 41
• Adverse Events Reporting (2004.07- )
until December 31, 2004
suspected case-reports: 817 (451 in 2004);
summary reports from manufacturer:
241 (143 in 2004)
State Food and Drug Administration,China 42
Manufacturers, distributors, user facilities
Provincial Center for MD Adverse Events monitoring
National Center for ADR Monitoring
Serious injury,10 days
Serious injury,10 days
Death, at once
Death, at once
Suspect Adverse Events Case Report
State Food and Drug Administration,China 43
Manufacturers
Provincial Center for MD Adverse Events Monitoring
National Center for ADR Monitoring
20 days
Quarterly
Summary Report for Manufacturers
State Food and Drug Administration,China 44
Examples
Polyacrylamide Hydrogel
Cornea Contact Lens (OK Lens)
State Food and Drug Administration,China 45
Principle on the establishment of MDV system
Go around one destination
Pay attention to two points for reference
Establish three systems
Practice four integrations
State Food and Drug Administration,China 46
Provisions on the Adverse Events Monitoring and Re-evaluation of Medical Devices (Draft)
7 chapters, 41 ArticlesChapter 1 General ProvisionsChapter 2 Organizations and ResponsibilityChapter 3 Reporting and AssessmentChapter 4 Re-evaluation of the ProductChapter 5 Control of Serious EventsChapter 6 PenaltiesChapter 7 Supplementary Provisions
State Food and Drug Administration,China 47
Main Contents
Issued bySFDA & MOH
Definitions adverse event, reportable adverse
event, adverse event monitoring, re-evaluationOrganizations and Responsibility
State Food and Drug Administration,China 48
Main Contents
Reporting and Assessment of Adverse EventsInitial Report --- for manufacturer, distributor and user facility;Follow Report --- for manufacturer; Summary Report --- only for manufacturer of Class II & III products
State Food and Drug Administration,China 49
Manufacturer
Provincial Technical Center for Medical Device Adverse Events
Monitoring
National Center for Adverse Drug Reactions Monitoring
MOH
Distributor User Facility
SFDA
IR-5,15dFR-20dSR-each yr(ClassⅡ,Ⅲ)
IR-5,15d IR-5,15d
IR-5,15dFR-15dSR-30d
PSR PSR
State Food and Drug Administration,China 50
Main Contents
Re-evaluation of ProductManufacturersRegulatory Agencies and
their Technical Organizations
State Food and Drug Administration,China 51
Main Contents
Control of Serious Adverse EventsDistributor, User FacilityManufacturerRegulatory Agency
PenaltiesManufacturer, Distributor, User FacilityMedical Institution (Hospital, Clinic etc)
State Food and Drug Administration,China 52
Work Plan in 2005
Formulate “Provisions on the Reconditioned Medical Device
Administration
Formulate “Provisions on IVD (Medical Device) Registration”
Formulate “Detailed Rules on the Technical Review for Specific
Registration Products ” (by category)
Revise “Provisions on Medical Device Standardization”
Revise “Provisions on the Qualification Certification of Medical
Device Testing Centers”
State Food and Drug Administration,China 53
Formulate “Working Procedure for Drafting the SFDA Standards”
Formulate “Good Manufacturing Practices for Medical Devices” (QSR)
Formulate “Provisions on MD Adverse Events Monitoring &
Reevaluation” (MDV)
Formulate “Provisions on Medical Device Recall”
Reinforce and improve the daily supervision, in combination with the
establishment of the credibility system
State Food and Drug Administration,China 54
For more information
http://www.sfda.gov.cnhttp://www.cmdi.gov.cn
My Email: [email protected] [email protected]
State Food and Drug Administration,China 55