China medical device classification results have been reported on the National Institutes for Food and Drug Control (NIFDC) website since 2018 and continues to be updated by the NIFDC periodically. There were three summaries of classification results released in 2022 this year, and the latest summary was released on October 27, 2022, covering the results below collected from July to September 2022:
| Total number of medical device classification results: | 388 |
| Number of products recommended to be managed as class III medical devices: | 45 |
| Number of products recommended to be managed as class II medical devices: | 149 |
| Number of products recommended to be managed as class I medical devices: | 98 |
| Number of products not recommended to be managed as medical devices: | 75 |
| Number of products recommended to carry out the classification application of drug-device combination products: | 4 |
| Number of products with classification results subject to specific situations: | 2 |
| Number of products not recommended to be solely managed as medical devices: | 15 |
The results are derived from a comprehensive study based on existing policies, the Chinese classification catalogue, and product information provided by applicants.
Why apply for classification?
Prior to applying for medical device registration in China, manufacturers are advised to consult the NIFDC when unsure about the risk classification of their products in China, especially for newly developed products that are not yet listed in the Chinese classification catalogue.
Once the application and the application dossier are received by mail or submitted on the NIFDC online portal, the NIFDC completes the product assessment in 20 working days, and may ask the applicant to submit supplementary information within 30 working days. With the assistance of an experienced local agent in China like Cisema, normally it takes 3 months from preparing for the application to receiving the classification results.
Chinese medical device classification catalogue
On October 31, 2022, the Center for Medical Device Standardization Administration (CMDS) under the NIFDC released an amendment draft of the classification catalogue covering the proposed changes for 57 medical devices. Public comments can be sent to flmsc@nifdc.org.cn on or before November 24, 2022, to help the regulatory authority finalize the implementation details.
In order to keep up with the ever-changing medtech development in China, the official medical device classification catalogue can be seen updated by the China regulatory authorities a few times every year. Manufacturers selling or planning to sell in China should keep themselves well-informed about the latest changes of the medical device classification catalogue to prepare for the upcoming application for product registration or renewal of the registration certificate.
Cisema offers pre-market and post-market approval services to manufacturers who seek support with the submission of the China medical device classification application, and regulatory update monitoring and reporting. Contact us if you would like to learn more.
