Drugdu.com expert's response:

The domestic NMPA registration process for medical devices adopts three differentiated procedures based on the product risk level, as detailed below:

I. Pre-procedure for Classification Definition

First, clarify the risk category of the product: Class I medical devices are subject to ‌filing management‌, while Class II and Class III medical devices are subject to ‌registration management‌. If the product attributes are ambiguous, you may first apply to the drug regulatory authority for classification definition, and initiate subsequent registration procedures only after obtaining a clear category determination result.

II. Core Procedures for Classification-based Registration

‌Class I Medical Device Filing‌: Prepare documents including product technical requirements, safety risk analysis, and production system-related materials, and submit the filing application to the municipal drug regulatory authority. A filing certificate can be obtained quickly if the documents are compliant, with no clinical trials required.

‌Class II Medical Device Registration‌: Complete R&D and verification of the product first, carry out clinical trials that meet relevant requirements (products within the exemption catalog can skip clinical trials), compile a full set of registration documents and submit them to the provincial drug regulatory authority. A Class II medical device registration certificate will be issued after passing technical review and system inspection.

‌Class III Medical Device Registration‌: As the highest-risk category, it requires strict full-process product performance verification and standardized multi-center clinical trials. The registration application shall be submitted to the National Medical Products Administration. A Class III medical device registration certificate can only be approved after passing national-level technical review and on-site production system inspection.

III. General Supporting Requirements

Products applying for registration must comply with China's mandatory standards for medical devices. The certificate obtained after successful registration is valid for ‌5 years‌, and the renewal registration must be completed 6 months before the expiration date. After obtaining the NMPA registration certificate, the enterprise can apply for the corresponding production license, which also meets the basic preconditions for applying for the medical device export qualification you learned about earlier.