Introduction of CFDA Approved Combination Products

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In 2017, CFDA announced the first batch of approved combination products in China

In 2017, CFDA announced the first batch of approved combination products since the release of the combination product registration guideline in 2009. There are currently four combination products approved by CFDA. If a manufacturer has questions on whether its product should be regulated as combination products by CFDA, a product identification request can be submitted and reviewed by CFDA. Contact China Med Device to learn more about our services for combination products. 

1. Gastroscope glue (Lidocaine hydrochloride included)

This is a combination product with device primary mode of action. This product is made of dimethicone, polysorbate 80, lidocaine hydrochloride, glycerin, ethylparaben and distilled water. It is used for gastroscope diagnosis.

2. Paclitaxel release coronary balloon catheter

This is a combination product with device primary mode of action. This product is an RX balloon dilatation catheter consisting of a balloon and a catheter as main components. The balloon is made of nylon elastomer/linear low-density polyethylene and coated with Taxol. It is used for the treatment of coronary in-stent restenosis.

3. Double-sided patch with antibacterial coating

This is a combination product with device primary mode of action. This product consists of expanded polytetrafluoroethylene and an antibacterial coating (silver carbonate and chlorhexidine acetate). It is used for tendon and soft tissue defects reconstruction and temporary bridging of fascia defects.

4. microporous patch with antibacterial coating

This is a combination product with device primary mode of action. This product consists of expanded polytetrafluoroethylene and an antibacterial coating (silver carbonate and chlorhexidine acetate) with a physical structure containing regularly spaced pores. It is used for tendon and soft tissue defects reconstruction and temporary bridging of fascia defects.

 

For inquiries of regulatory and commercialization services for China combination device market, please email info@ChinaMedDevice.com.

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About China Med Device, LLC 

China Med Device, LLC provides turn-key solutions for western medical device/IVD companies to enter China with regulation and commercialization services. Our CFDA regulatory services cover strategy, premarket submission, 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 200+ companies’ success.