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)

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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

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Department of Medical Devices① Division of Standardization

② Division of Product Registration

③ Division of Safety & Supervision

Department of Drug Market Compliance

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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

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MD Regulatory System in China

1．Regulation (issued by the State Council)

2. SFDA Orders

3．SFDA Documents

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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.

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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)

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(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)

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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)

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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

………

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Medical Device Registration

(presented by Mr. Chang Yongheng)

Medical Device Standardization

Supervision over Medical Device Manufacturing

Medical Device Vigilance

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2. Medical Device Standardization

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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) ………

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"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.

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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.

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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)

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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

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• 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

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• Qualification certification for testing centers

2004: 27 testing centers certified;

other 7 inspections completed

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3. Supervision over Medical Device Manufacturing

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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) ………

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Medical Device Manufacturing

Enterprise Licensing & Informing

Manufacturer of Class II, III product;

Manufacturer of Class I II III product

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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)

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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

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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

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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

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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

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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

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Framework of GMP Regulation

General rules

Implementation guidelines (by category)

Detailed implementation rules on product

manufacturing (by product)

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Working Progress◊ Sterile device◊ Implantable device

Working Plan

Responsibility for GMPSFDA

Local agencies in provincial and below

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4. Medical Device Vigilance

----Monitoring and Reevaluation

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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) ………

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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

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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)

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• Technical Supporting Organizations

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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)

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Participants: Beijing, Shanghai, Guangdong province

plus other 5 hospitals and 8 manufactures

Totally：50 manufactures; 232 distributors;

268 hospitals were involved

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• Adverse Events Reporting (2004.07- )

until December 31, 2004

suspected case-reports: 817 (451 in 2004);

summary reports from manufacturer:

241 (143 in 2004)

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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

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Manufacturers

Provincial Center for MD Adverse Events Monitoring

National Center for ADR Monitoring

20 days

Quarterly

Summary Report for Manufacturers

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Examples

Polyacrylamide Hydrogel

Cornea Contact Lens (OK Lens)

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Principle on the establishment of MDV system

Go around one destination

Pay attention to two points for reference

Establish three systems

Practice four integrations

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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

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Main Contents

Issued bySFDA & MOH

Definitions adverse event, reportable adverse

event, adverse event monitoring, re-evaluationOrganizations and Responsibility

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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

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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

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Main Contents

Re-evaluation of ProductManufacturersRegulatory Agencies and

their Technical Organizations

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Main Contents

Control of Serious Adverse EventsDistributor, User FacilityManufacturerRegulatory Agency

PenaltiesManufacturer, Distributor, User FacilityMedical Institution (Hospital, Clinic etc)

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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”

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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

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For more information

http://www.sfda.gov.cnhttp://www.cmdi.gov.cn

My Email: sfdawlm@126.com wlanming@sina.com

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