With the NMPA, a medical device’s technical dossier involves documentation of the raw materials. The applicants for medical device registration shall guide and assist the product owner to establish the main technical dossier, according to the relevant requirements of the medical device registration application dossiers. The applicants for medical device registration shall be fully responsible for the applied medical device.
This notice applies to the technical dossier used in the registration, change notification applications, and clinical trial approvals of imported class II, class III, and domestic class III medical devices (including IVD reagents), which are filed by applicants for medical device registration in the territory of China.
China's Center for Medical Device Evaluation (CMDE) has established a registration platform and a database for these technical dossiers. The owner of the dossier can submit the registration data, according to the requirements of this Notice through the registration platform and obtain the registration number for their dossier upon successful registration. After the application for registration of the medical devices is made, the CMDE will review the technical dossier.
Registration of these medical devices’ technical dossiers is voluntary. Domestic product owners may apply for registration of the technical dossier by themselves. Foreign product owners, on the other hand, shall authorize a local agent to apply for this registration. The registration data of the technical dossier shall be signed and sealed by the product owner, including the application form for registration (update) of the medical device’s technical dossier and the attached registration data and technical data. The simplified Chinese translation of foreign language documents shall also be provided (the Chinese translation can be signed by the domestic agent).
The technical dossier’s registration data and signature are applicable to the requirements of the electronic application of medical device registration. After the product owner or agent applies for the CA used in conjunction with eRPS system, they shall submit the Application Form for Registration of Medical Device Technical Dossier or the Application Form for Registration and Update of Medical Device Technical Dossier, whereby the registration data and technical data attached to the application form are uploaded in the electronic application system. After the data is submitted successfully, the CMDE will send the Registration Receipt of Medical Device Technical Dossier to the product owner or agent. Registration receipt only certifies that the technical dossier is archived for reference of medical device registration and other application items. The CMDE will then proceed to publish the technical dossier registration information on its official website, in good time for a public inquiry.
When the content of the registered medical device technical dossier changes, the product owner can apply to update the registration data.
This Notice takes effect as of the date of issuance.