RAPS Convergence 2022

China NMPA issued the "Guidance on Application Materials for Classification Attributes of Medical Devices" on June 14, 2023. It is applicable to both China and overseas manufacturers. Classification catalogue is one of the most important references to determine medical device classification. When devices are not covered in the classification catalogue, to determine whether it is drug or medical device or non-medical device etc., you will need to file a classification. 

Application Website

NMPA provides a website https://www.nifdc.org.cn for applicants to login and submit their classification attributes application.

Document Requirements

• For imported devices, the approval certificate, IFU and other relevant materials shall have original and Chinese translation copies. The approval certificate shall include key information such as the classification in the country of origin, the expiration date of the document, etc.
• For the approval certificate, IFU, product technical requirements (PTRs) and other documents, meaning of Chinese translation shall be consistent with that of the original country.
• The product manual shall be that of the final product. The main content shall meet the requirements of the Provisions on the Administration of Medical Device Manuals and Labels.
• PTRs shall be that of the final product. And the technical indicators in the application materials are the same as the indicators of the later listed products. Where the technical provisions of the national standard or industry standard are adopted, the effective date and number of the standard shall be indicated.
• Supportive documents for key contents such as working principle, mechanism of action and main risks.
• Key information such as product name, structure, function, and purpose shall be consistent across documents. For example, information about accessories shall be consistent with that of the host device.
• The signature of all documents shall match the applicant's name.

NMPA Medical Devices Classification Attribute Guideline has three indexes:

1. Application Submission List
2. List of Application Documents
3. Normative Requirements

When you cannot find your device in the medical device classification catalogue, you will need to file for classification. If you have any questions about the classification attributes guideline by NMPA, please email me.

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Grace Fu
China Med Device, LLC
MA, U.S.
gpalma@ChinaMedDevice.com
978-390-4453
www.ChinaMedDevice.com
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