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).
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
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.
|Non Drug-device combination products||1. Administered as drug||33||63|
|2. Administered as medical device||13|
|3. None drug-device combination product, subject to registration separately||5|
|4. Not a drug-device combination product||12|
|Drug-device combination products||5. Drug-based combination product||42||76|
|6. Device-based combination product||34|
There are currently four combination products approved by NMPA(CFDA), please click HERE to learn more details about approved combination products in China.
Keep yourself updated with CFDA News Roundup, click HERE to opt-in.
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.