On July 27, 2021, the NMPA (National Medical Products Administration) released the finalized version (No.52-2021) of the “Notice on Matters related to the Registration of Drug-Device Combination Products” and also the explanatory notes to support the implementation, with immediate effect.
The new regulation (No.52-2021) clarifies the registration requirements and classification method of different drug-device combination products, and abolishes the previous version (No.16-2009) of the same regulation and the “Notice on Matters related to Modifying the Classification of Drug-Device Combination Products” (No.28-2019). The revised draft of this regulation was published by the NMPA on January 12, 2021 (more information available in our previous blog post).
- From July 27, 2021, onwards, if the drug or medical device is a part of the combination product, but neither one of them has obtained the marketing approval from its country of origin or the China registration approval, such approvals will not be necessary for the registration of the combination product in China.
- When applying for the classification of combination products in China, applicants should refer to the new regulation (No.52-2021) instead of the abolished “Notice on Matters related to Modifying the Classification of Drug-Device Combination Products” (No.28-2019). Applicants should pay attention to the new arrangements and requirements in terms of the department responsible, application procedure, time limitation, materials submitted, etc. as below:
- Applications must be submitted to the Center for Medical Device Standardization Administration (hereinafter referred to as “the Center”) through the NIFDC’s (National Institutes for Food and Drug Control) online portal.
- After the preliminary review of the application, if the Center decides that supplementary materials will be need to support the application, the applicant should be notified within 5 working days after submitting the application.
- The applicant must collect and submit the list of supplementary materials addressed by the Center within 60 working days. Otherwise, any additional materials received after the deadline will not be accepted and the application will be rejected to proceed further.
- If there are any disagreements with the classification results, the applicant may submit a request to the center within 10 working days to review the application, and receive the final classification results 20 working days later.
- Applicants can monitor the status of the application through the NIFDC’s online portal.
- In the past, the procedure to classify and register different kinds of Drug-Device Combination Products was unclear, and there were no clear guidelines to which department should the registrants submit the application to. Since this new regulation came into effect, the standard procedure and responsible departments are now clear as listed in the following:
- Submit classification to “Standardization Management Center” of the NMPA.
- NMPA will decide whether the product is a drug-based combination product or a medical device-based combination product.
- If the combination product is classified as drug-based, the manufacturer should submit the application to the CDE (Center for Drug Evaluation). The CDE is mainly in charge of the technical review of drug-based combination product applications whilst the CMDE (Center for Medical Device Evaluation) provides support to the CDE .
- If the combination product is classified as medical device-based, the manufacturer should submit the application to CMDE. The CMDE is mainly in charge of technical review of medical device-based combination product applications whilst the CDE provide support to the CMDE.
By Jimmy Xi and Jacky Li. Contact Cisema if you would like to learn more.