China Releases New List of Standards for Medical Device Registration

In a significant update for medical device manufacturers and registrants, the National Medical Products Administration (NMPA) has released the 2024 revised edition of the “List of Mandatory Standards Applicable to Medical Device Products.” (pdf, original Chinese) This revised list aims to guide applicants in effectively utilizing mandatory national and industry standards for medical devices, ensuring compliance with the latest regulatory requirements. This guidance provides welcome clarity to applicants and a framework for faster processing for reviewers.

Key Highlights of the 2024 Revised List

1. Framework and Scope

• The list is structured based on the secondary product catalog of the “Medical Device Classification Catalog.” (pdf, original Chinese) It outlines the mandatory national and industry standards applicable to various products within the classification catalog.

2. Adapting to Standard Changes

• If there are changes to mandatory standards during the validity period of a medical device registration certificate, registrants must comply with the “Medical Device Registration and Filing Management Measures” (pdf, original Chinese) to address these changes.
• Registrants are encouraged to proactively implement new mandatory standards. For products not included in the list, any changes in applicable standards must also be adhered to.

3. Handling New Standards During Certificate Validity

• When a new mandatory standard is issued during the registration certificate’s validity period, the registration certificate remains valid if:
  • The product technical requirements directly cite specific clauses of the mandatory standard, and the content of these clauses does not change despite the standard number or year number updating.
  • The product technical requirements reference the content of a mandatory standard clause that does not change, or if it does change, the technical requirements still cite the pre-update content.
• In these situations, there is no need to apply for a change in registration, as only the referenced standard number and/or year number are updated.

4. Additional Considerations

• Product Name Discrepancies: If the declared product name differs from the list but the product performance aligns, the actual content of the declared materials takes precedence, and the registration should be made according to the applicable mandatory standards for the declared product.
• Dynamic Updates: The list is dynamic and updated in real-time based on new standards issued by the Medical Device Standard Management Center. It serves as a reference for registration applications.
• Regulatory Adaptations: The list is based on current laws, regulations, and standards. As these evolve, the list will be adjusted accordingly to ensure ongoing compliance.

Asia Actual’s regulatory experts in Beijing are available to assist overseas medical device manufacturers to understand and navigate the medical device registration process in China. Contact us with any questions for support requests.