Class I medical devices in China generally require compliance with applicable national standards and regulations to obtain registration with the National Medical Products Administration (NMPA). Here are some key standards and regulations that typically apply:

1. GB Standards:

   • GB 9706.x Series: General requirements for safety and essential performance of medical electrical equipment.
   • GB 16886.x Series: Biological evaluation of medical devices.
   • GB/T 14710: Environmental requirement and test methods for medical electrical equipment.
   • GB 18278: Sterilization of medical devices - Requirements for validation and routine control - Radiation sterilization.

2. YY Standards:

   • YY 0466: Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied.
   • YY/T 0287: Sterilization of health care products - Chemical indicators - Guidance for selection, use and interpretation of results.

3. ISO Standards (International Organization for Standardization):

   • ISO 13485: Quality management systems - Requirements for regulatory purposes, specifically for medical device manufacturers.
   • ISO 14971: Application of risk management to medical devices.

4. IEC Standards (International Electrotechnical Commission):

   • IEC 60601-1: Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
   • IEC 60601-1-2: Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests.

5. Other Relevant Standards:

   • Pharmacopoeia standards for pharmaceuticals and medical devices.
   • National Pharmacopoeia for testing and quality control requirements.

Compliance and Documentation:

• Declaration of Conformity: Manufacturers must declare that their devices comply with relevant Chinese standards and regulations.

• Testing and Certification: Ensure that your device has undergone necessary testing and certification processes to demonstrate compliance with these standards.

• Translation Requirement: All documentation submitted to the NMPA must be translated into Chinese.

Verification and Updates:

• NMPA Updates: Stay updated with any changes or updates in standards or regulatory requirements issued by the NMPA.

• Local Agent Support: Working with a qualified local agent in China can facilitate compliance with standards and regulations and provide guidance on navigating the registration process.

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