| 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: |
Art.2 - These Regulations apply to the development, production, operation, use of medical devices and their supervision and management within the territory of the People's Republic of China.
Art.6 - The state implements classified management of medical devices according to the degree of risk.
Class I: The first category are low-risk medical devices whose safety and effectiveness can be guaranteed through routine management.
Class II: The second category are medical devices with moderate risks that require strict control and management to ensure their safety and effectiveness.
Class III: The third category are medical devices with high risks and special measures need to be strictly controlled and managed to ensure their safety and effectiveness.
To evaluate the degree of risk of a medical device, factors such as the intended purpose, structural characteristics, and method of use of the medical device should be considered.
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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