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Registration Guideline on Drug & Device Combination Products Asks Feedback

2021-02-08

NMPA’s CMDE announced its preparation of “Registration Guideline on Drug & Device Combination Products” for public comments on January 12, 2021. Any feedback needs to be submitted by January 26, 2021.

  1. The document specifies the following:Drug& Device Combination Products refers to the product composed of drug(s) and medical device(s) which is produced as a single entity.
  2. Which center the product is assigned to is based on a determination of the “primary mode of action” (PMOA) of the combination product. For example, if the PMOA is attributable to the medical device, the Center of Medical Device Evaluation will be mainly responsible.
  3. The simultaneous reviews by the two centers are possible when needed
  4. NMPA Combination Product Classification Center will determine the product category. For the classification procedures, please contact us.
  5. Following examples of combination products are medical devices:
  • Drug-coated stent
  • antibacterial-coated catheter
  • medicated condom
  • medicated birth control rings
  1. Following examples aredrugs:
  • band-aid containing antibacterial or anti-inflammatory drugs
  • Chinese medicine for external application

 

This is a great opportunity to have your voices heard by NMPA reviewers and influence them to form a more practical guideline in the end. A thorough and realistic guidance document not only helps NMPA reviewers during their technical review process but also guides manufacturers to satisfy NMPA’s requirements. For more information about how to develop a feedback strategy or assistance in submitting your inputs, please contact info@inspirativemed.com.

 

Link: https://www.nmpa.gov.cn/xxgk/zhqyj/zhqyjylqx/20210112170437160.html