What are the NMPA(CFDA) interpretation of the combination products attributes?

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What are the NMPA(CFDA) interpretation of the combination products attributes?

In order to guide the applicant to make proper application, NMPA(CFDA) has published the summary of the attribute definition results of drug-device combination products starting from 2009 to the present. These results are from applications for attribute classification submitted to NMPA. There are 8 announcements in total. For detailed attribute definition results about the combination products in China, please contact ChinaMed Device, LLC (info@ChinaMedDevice.com).

 

  1. Common products under application for definition:

  • Drug-coated devices, drug-impregnated devices or drug-device combination products
  • Prefilled drug delivery device/system
  • Prefilled biological product delivery device/system
  • Biological drug-coated devices or biological drug-device combination products
  • Others
  1. A Summary of the Attribute Definition Results

Since China and the United States have different definitions of combination products, some combination products in the United States are not considered to be combination products in China. The following is a summary of the results that have been applied for classification.

Definition resultsTotal
Non Drug-device combination products1. Administered as drug3363
2. Administered as medical device13
3. None drug-device combination product, subject to registration separately5
4. Not a drug-device combination product12
Drug-device combination products5. Drug-based combination product4276
6. Device-based combination product34
Total138138

 

There are currently four combination products approved by NMPA(CFDA), please click HERE to learn more details about approved combination products in China.

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About ChinaMed Device, LLC 

ChinaMed Device, LLC (www.ChinaMedDevice.com), a Boston headquartered company, provides regulatory and commercialization turnkey solutions for western medical device, IVD, CDx and combination products to enter China. Our NMPA (CFDA) regulatory services include: RA, regulatory strategy, regulatory submissions, clinical evaluation reports (CER), clinical trials, QA, GMP and post-market compliance. Our commercialization services include: market assessment research, reimbursement, partnership strategies, and distribution qualification. We are a NMPA (CFDA) certified legal agent with offices in Boston and Beijing enabling us to service our clients 24/7.