| Scope: |
This ESSENTIAL describes the regulatory requirements of medical devices in the People's Republic of China, based on the
- China State Orders
- SAMR Decree
- NMPA Announcements
This ESSENTIAL describes the regulatory requirements for manufacturers with production plants abroad (not located in Chinese territory). For local production, different regulations do exist.
In scope of this ESSENTIAL are Medical Products, Classes I, II, III.
Not in scope of this CRF:
- In-Vitro Diagnostics
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| Legislation in force: |
Medical Device Supervision and Administration Regulations
Art.2) These Regulations shall apply to the research, production, operation, use and supervision and administration of medical devices within the territory of the People's Republic of China.
Art.6) The state implements classified management of medical devices according to their risk levels.
Class 1: medical devices with low risk levels, whose safety and effectiveness can be guaranteed by routine management.
Class 2: medical devices with moderate risks that require strict control and management to ensure their safety and effectiveness.
Class 3: medical devices that have higher risks and require special measures to strictly control and manage to ensure their safety and effectiveness.
Art.7) Medical device products shall comply with the mandatory national standards for medical devices; if there are no mandatory national standards, they shall comply with the mandatory industry standards for medical devices.
Art.13) Class I medical devices are subject to product filing management, while Class II and Class III medical devices are subject to product registration management.
CONTENT:
Chapter 1 - General Provisions
Chapter 2 - Registration and Filing of Medical Device Products
Chapter 3 - Medical Device Production
Chapter 4 - Operation and Use of Medical Devices
Chapter 5 - Handling of Adverse Events and Recall of Medical Devices
Chapter 6 - Supervision and Inspection
Chapter 7 - Legal Liability
Chapter 8 - Supplementary Provisions
Administrative Measures for Medical Device Registration and Filing
This regulation applies to medical device registration, filing and supervision and management activities within the territory of the People's Republic of China.
Content:
Chapter 1 General Provisions
Chapter II Basic Requirements
Chapter III Medical Device Registration
Section 1 Product Development
Section 2 Clinical Evaluation
Section 3 Registration System Verification
Section 4 Product Registration
Chapter IV Special Registration Procedures
Section 1 Registration Procedures for Innovative Products
Section 2 Priority Registration Procedures
Section 3 Emergency Registration Procedures
Chapter V Modification of Registration and Continuation of Registration
Section 1 Change Registration
Section 2 Continuation of Registration
Chapter VI Medical Device Filing
Chapter VII Working Hours
Chapter VIII Supervision and Management
Chapter IX Legal Responsibilities
Chapter X Supplementary Provisions
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| Comment on the comparability to EU legislation: |
Not comparable with EU Medical Devices Regulation (Regulation (EU) 2017/745)... |