Brief Introduction of Medical Device Regulations in China

1
Brief Introduction of Medical Device Regulations
in China Zhang Gao-tong Department of
Policies and Regulations SFDA,P.R.China Novembe
r 2008
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The Agency

• The State Food and Drug Administration (SFDA ) is
  a state agency within the Ministry of Health.
• It is the competent authority in charge of
  supervising food, drug, and medical devices. Its
  mission is to protect and promote the public
  health by assuring the safety, efficacy, and
  security of food and medical products
• SFDA consists of ten departments/offices, which
  are listed below.

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Organizational Structure

• General Office (Department of Financial Planning)
• Department Of Policy Regulations
• Department of Food Safety Coordination
• Department of Food Safety Supervision
• Department of Drug Registration
• Department of Medical Devices
• Department of Drug Safety Inspection
• Department of Drug Market Compliance
• Department of Personnel Education
• Department of International Cooperation

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MD related Departments in SFDA and Main
Responsibilities

• Department of Medical Devices
• To organize and draft national medical device
  standards, supervise their implementation
  formulate the list of classified medical devices
  be in charge of registration and regulation of
  medical devices draw up GCP /GMP/GSP rules and
  supervise their implementation supervise the
  licensing of manufacturers and distributors for
  medical devices monitor adverse events and
  organize re-evaluation of medical devices.

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MD related Departments in SFDA and Main
Responsibilities

• Department of Drug Market Compliance
• To draw up supervision and enforcement
  requirements regarding marketed drugs and medical
  devices direct and give guidance to local drug
  regulatory bodies with respect to
  law-enforcement, emergency response management,
  advertisement reviewing, products recall
  organize investigation and prosecution of
  relevant illegal activities.

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MD related Departments in SFDA and Main
Responsibilities

• Department of Policy Regulations
• To participate in drafting and revising
  administration laws, regulations and agency
  provisions concerning food, drug and medical
  devices supervise administrative law-enforcement
  and take charge of the work of hearing, undertake
  administrative reconsideration.

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CURRENT MD RULES

• 2 Regulations promulgated by State Council
• Agency Provisions, issued by SFDA/SDA Orders
  (Relevant agencies may join), implementing NPC
  laws and State Council regulations
• Relevant agency requirements, issued by SFDA/SDA
  Notices and Documents, implementing laws,
  regulations and SFDA/SDA orders

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• Regulations for the Supervision and
  Administration of Medical Devices
• Decree 276 of the State Council,
• issued on January 4, 2000,
• effective since April 1, 2000.
• 5 chapters, 48 articles, primary and highest
  medical device regulations.

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OUTLINES OF MD REG.

• 1. Aim
• Strengthening the supervision and
  administration of medical devices, ensuring their
  safety and effectiveness and protecting human
  health and life safety
• 2. Who should Observe?
• Any institution or individual engaged in
  research, manufacturing, distribution, use and
  administration of medical devices.

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OUTLINES OF MD REG.

• 3.Definition of Medical Devices ( Similar as
  most countries )
• 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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OUTLINES OF MD REG.

• 4. Product Classification 3 classes.
• Class I Medical Devices are those for which
  safety and effectiveness can be ensured through
  routine administration
• Class II Medical Devices are those for which
  further control is required to ensure their
  safety and effectiveness
• Class III Medical Devices are those which are
  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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OUTLINES OF MD REG.

• 5. Product Registration
• 6. Licensing of Manufacturers and Distributors
• 7. Post Marketing Surveillance
• 8. Advertisements Review and Approval

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Agency ORDERS

• Provisions for Medical Device Registration (SFDA
  Order No. 16, Aug 2004)
• Rules for Medical Device Classification (SDA
  Order No. 15, Apr 2000)
• Provisions for Medical Device Standards (SDA
  Order No. 31, Jan 2002)
• Provisions for Clinical Trails of Medical Devices
  (SFDA Order No. 5, Jan 2004)
• Provisions for Supervision on Medical Devices
  Manufacturing (SFDA Order No.12, July 2004)

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Agency Provisions

• Provisions for Evaluation of the Quality System
  of Medical Devices (SDA Order No.22, July 2000)
• Provisions for Indications, Labels and Parking
  Marks of Medical Devices (SFDA Order No.10, July
  2004)
• Provisions for Supervision on Medical Devices
  Distributors (SFDA Order No.15, Aug 2004)
• Provisions for the Examination of Medical Devices
  Advertisements (Joint Order with The State
  Administration for Industry Commerce, SAIC
  No.15, March 1995)

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• 2.Special Rules on Strengthening the Supervision
  and Management of the Safety of Food and Other
  Products
• Decree 503 of the State Council
• July 26, 2007,
• 20 articles, mainly targeted food safety,
  applicable to medical devices.

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• The Special Rules aims to further enhance the
  product supervision and management capability of
  agencies clearly define the liability of
  enterprises for the product quality, and the
  responsibility of the Local governments for
  oversighting locally produced product.
• Explicitly provide the voluntary recall
  responsibility for manufacturers,
• and mandatory recall authority for the regulatory
  bodies.

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REVISING MD REG.

• Start 2nd half of 2006
• SFDA departments involved Department of Policy
  and Regulations, Department of Medical Devices,
  Department of Drug Market Surveillance
• SFDA s Affiliated organizations involved
  National Institute for the Control of
  Pharmaceutical and Biological Products, Drug
  Certification Center of SFDA, National Center for
  ADR Monitoring, Center of Medical Device
  Evaluation, SFDA
• Provincial Level Food and Drug Bureaus, Experts,
  China Association for Medical Devices Industry,
  etc. also participating in the process.

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Why to Revise?

• First set of medical device regulations issued by
  State Council
• Has played an import role in strengthening and
  standardizing the supervision and administration
  of MD in China
• Considerably good results have been achieved in
  the 8 years However,
• Development of the national economy, deepening of
  reform, heightening of lawful administration
  requirements
• Formulated and issued 8 years ago and not fully
  adaptable to current need.
• Not systematic enough and not detailed enough
• Not enough penalties

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Process

• Beginning 2007 Task study doneEnd of March
  2007 Basic ideas formedEnd of July 2007 First
  draft completedAug. and early Sep. Discussion
  and revision of FDSep. 21, 2007 Put on internet
  for publicly solicits opinions.
• March 2008SFDA Proposed Revision Submited to
  the State Council
• Now under the Reviewing of the Legislative
  Affairs Office of the State Council according to
  Legislation Procedure Law

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Main Points

• To better protect and promote public health.
• Essential Requirements
• GCP,GMP(quality system requirements)
• User facilities
• Imports exports
• Advertisement control
• Adverse events monitor, product recall

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Thank you very much.