From 2009 to the present, a total of 138 products have been applied for classification, and nearly one-third of the products were applied in 2017 and 2018. The market for Drug-Device Combination Products is gradually expanding in China.
With the development and integration of modern high-tech medical technology, researchers have put drugs, biologics and medical devices together to develop a new form of medical products – combination products. Due to the variety and complexity of such products, the management and classification may not be easily determined. The China Food and Drug Administration issued the “Guideline for Registration of Drug-Device Combination Product” in 2009. As of today, there are only four combination products approved by CFDA.
Below are some key points for registering drug-device combination products in China.
- Definition: The drug-device combination product refers to a product that involves a medical device and a drug and produced as a single entity.
- For the drug-device combination products whose primary mode of action is drug, it should submit the drug registration. If the primary mode of action is medical device, it should submit the medical device registration.
- If a product has not been identified in China as a drug-device combination product, the applicant shall submit a product classification request to CFDA before submitting the registration application.
- CFDA will assign a team of experts to review the product classification request. The applicant sh0all receive a notification from CFDA of product classification within 20 business days
- For the first-time import drug-device combination product, the application will not be accepted if this product has not been approved by the home countries (regions). If the drugs involved in the combination products have not been registered or have not been approved by the producing country (region), the application will also not be accepted.
- Stents with drug coatings, catheters with antibacterial coatings, drug-containing condoms, drug-containing birth control rings, and other products, are registered as medical devices. Wound stickers containing antibacterial and anti-inflammatory drugs, and Chinese medicine for external use are registered as drug.
For CFDA link of Guideline for Registration of Drug-Device Combination Product, please email info@ChinaMedDevice.com.
About China Med Device, LLC
China Med Device, LLC (https://chinameddevice.com/) provides turn-key solutions for western medical device/IVD companies to enter China with regulation and commercialization services. Our CFDA regulatory services cover strategy, RA, clinical evaluation, CRO, QA and post market compliance. We are experienced in handling innovation approvals and priority reviews. Our commercial services cover market assessment research, reimbursement, partnership, distribution qualification and management. We have offices in Beijing, Suzhou and Boston. Our management team has 100+ years of combined experience in medical device and IVD and has been involved with 1,000+ CFDA certificates and 250+ companies’ success.