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Medical Devices and Combination Products


According to the U.S. Food and Drug Administration (US FDA), combination products are defined as the combination of any two of the follows, including drugs, medical devices and biopharmaceutical – which is a product with treatment and diagnosis function.

Existing products available in the market include antibacterial bone cement, drug-eluting stent for coronary artery diseases and wound dressings. Compared with conventional medical devices, the technical requirement is higher and regulatory standards become more rigorous; nonetheless the potential market is also more enormous. In terms of function, medical devices and combination products can solve the problems encountered by medical devices, such as biocompatibility and service life, which can more effectively meet the objectives for treatment.


The Medical and Pharmaceutical Industry Technology and Development Center has been devoted in pharmaceutical research for years and has considerable understanding on the properties of drugs. PITDC also sets up a R&D office for medical devices and has achieved certain performance regardless in the cooperation of suppliers for product development or assistance with suppliers for the application of government counseling cases. Apart from the R&D team, PITDC also offers specialists who will help suppliers with investigation and registration of medical devices and drugs. There are many cases of successful applications home and abroad that will assist the suppliers with avoidance of unnecessary risk and early access to the market.


Material Surface Modification / Chemical Grafting
1.Drug Delivery System
2.Microstructure Manufacturing
3.Biocompatibility Testing

▲Scope of Application

1.Dressings containing drugs, drug-dispensing contact lenses
2.Drug-coated conduit
3.Wound Dressings with Drugs
4.Drug-Eluting Stent
5.Tissue Engineering / Regenerative Medicine