Unable to identify the risk class or product category?

Author

Elaine Tan
February 25, 2025

Unable to identify the risk class or product category?

There are ways to identify risk class and/or product category for your medical device even though you can’t Chinese. Don’t worry and I got your back!

1. To browse the list of registered products in China

Run a quick search on the NMPA website by inserting the product keyword in Simplified Chinese. It is recommended that manufacturers refer to similar products that have obtained NMPA approval and use them as the predicate, if relevant.

Link to the official NMPA database to find which medical devices have been registered in China. https://www.nmpa.gov.cn/datasearch/home-index.html#category=ylqx

💡Tips: The applicant can submit and declare the product as a Class III medical device if the product is developed using a fairly new technology and has a considerably high risk. In this case, the product type may not been included in the Classification Catalogue. Alternatively, the applicant can apply for classification determination (see below) at NMPA and then prepare the submission document for registration or filing based on the NMPA’s decision on the product category and risk class.

The risk class may change even if similar products have been registered in China or included in the Classification Catalogue. This happens as we learn about the actual risks and obtain further clinical and real-world data after the product launch. It may introduce new risks or increase product risks if there are changes in the materials, production processes, working principles, structural composition, mechanism of action, contact parts and duration of contact, intended purposes, etc. have changed during the whole product lifecycle.

2. To Apply for NMPA’s classification determination

The good news is that there is a possibility to submit a request for the classification determination to NMPA in case of doubts. There are two possible scenarios:

  • As for the product with a distinct product category, NMPA will inform the classification results to the applicant.

  • For the product in which the risk class is vague or difficult to determine, NMPA will propose opinions on the classification determination with the rationales

How to apply for NMPA’s classification determination?

For newly developed medical that has not yet been considered within the Classification Catalogue, you can navigate to “Business Service” under the National Institutes for Food and Drug Control (NIFDC) website to submit your online request. This online service has been available since 2024.09.01 and the NMPA does not charge any fee.

The processing timeline is 20-30 working days, excluding the additional time needed for expert consultation, communication, and coordination with other authority departments, applicant request to provide supplementary documents, if any. If you appoint an in-country representative to apply, there may be a consulting fee.

Official link to apply for Classification Determination:

NMPA feedback is straightforward and short unless it is a newly developed medical device that has not yet been included in the Classification Catalogue.

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