CFDA Published Drug And Medical Device Overseas Inspection Regulations

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CFDA Published Drug And Medical Device Overseas Inspection Regulations

As part of an effort to standardize the overseas inspection of drug and medical device manufacturing and ensure the quality of imported products, the CFDA just published the Draft for Comments version of the Drug And Medical Device Overseas Inspection Regulations.

This document specifies details of the CFDA’s overseas inspection process with 5 chapters, 35 articles and 4 appendices:

Chapter I: General Provisions

Article 1 Legislative Purpose

Article 2 Scope of Application

Article 3 Definition of Terms

Article 4 Division of Responsibilities

Article 5 Information Disclosure

Article 6 Discipline Requirements

Chapter II: To Determine Inspection Tasks

Article 7 Inspection Plans

Article 8 Risk Assessment

Article 9 Inspection and Startup

Article 10 Inspection Time

Article 11 Inspection Composition

Article 12 Communication

Article 13 Coordination

Article 14 Working Language

Chapter III: Inspection

Article 15 Inspection Scheme

Article 16 First Meeting

Article 17 Inspection Cooperation

Article 18 Evidence Materials

Article 19 Sampling

Article 20 Immediate Report

Article 21 Last Meeting

Article 22 Inspection Report

Chapter IV: Review and Handling

Article 23 Inspection Defects

Article 24 Rectification

Article 25 Comprehensive Assessment

Article 26 Judgment principle

Article 27 No Cooperation

Article 28 Inspection Opinion

Article 29 Communication Statement

Article 30 Classified Treatment

Article 31 Investigation

Chapter V: Supplementary Provisions

Article 32 Hong Kong, Macau, Taiwan

Article 33 Explanation of terms

Article 34 Rights to Interpretation

Article 35 Implementation Date

Appendices

  1. Drug and Medical Device Overseas Inspection Notice
    2. Drug and Medical Device Overseas Inspection Basic Information Sheet
    3. “Factory Master” List
    4. Drug and Medical Device Overseas Inspection Defection List

This is a major effort by the CFDA to enforce quality control on devices manufactured overseas.

Do you want to see your medical device in China markets?

We encourage device manufacturers with facilities located outside of China’s mainland to review and comment on this draft. The China Medical Device team can help you with the review and approval process.

Contact us at info@chinameddevice.com with your questions and let’s begin a meaningful conversation that helps you achieve your business goals for your medical device.