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
- 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.