Service & Tech

Regulatory Affairs

Product Classification confirmation


For newly developed medical devices which are not included in the classification catalog and products whose category is not clearly identified, the applicant can determine the product category according to the classification rules and apply for category/attribute confirmation from relevant food and drug administrations of the State Council, or directly apply for registration in accordance with relevant provisions on Class III medical devices in the Regulations on the Supervision and Administration of Medical Devices.

The application for category/attribute confirmation shall be filed online. The Center for Medical Device Standards Management of NMPA established a medical device classification & confirmation information system on the secondary website of the National Institutes for Food and Drug Control. If the enterprises cannot determine the product category, attribute or classification code, they shall apply for category/attribute confirmation according to corresponding requirements. Application, review and result feedback are conducted online.


 Service Contents:


Prepare/review documents based on technical information provided by the enterprise

Track the review progress

Guide/edit supplementary data