The NMPA issued the “Guidance on Application Materials for Classification of Medical Devices” on June 14, 2023. It is applicable to both domestic and overseas manufacturers.
Applicants log into the website https://www.nifdc.org.cn, enter “Office Hall” – “Medical Device Standards and Classification Management” – “Medical Device Classification Definition Information System” to submit application materials online.
- For imported devices, the approval certificate, IFU and other relevant materials have original and Chinese translations. The approval certificate should include key information such as the classification in that country, the validity period of the document, etc.
- The approval certificate, IFU, product technical requirements (PTRs) and other documents shall be consistent between Chinese and that of original country.
- Product manual should be that of the final product. The main content should meet the requirements of the Provisions on the Administration of Medical Device Manuals and Labels.
- Product technical requirements should 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 implementation date and number of the standard shall be indicated.
- There should be clear materials for key contents such as working principle, mechanism of action and main risk points.
- Key information such as product name, structure, function, and purpose should be consistent across materials.
- For example, information of accessory products should be consistent with those of the host device.
- The signature of all documents should match the name of the applicant.
The NMPA Medical Devices Classification document has three indexes:
- Application Submission List
- List of application materials
- Normative requirements