CMDE Q&A | Can Bare Stents and Drug-eluting Stents Be Divided into the Same Registration Unit?

A:No.

The coating is an important component of a drug-eluting stent and has a major impact on the safety and efficacy of the product, and according to the passive medical device registry unit division principle of The Medical Device Registry Unit Division Guidelines, medicated devices with drug (active substance) versus without drug (active substance) are appropriately divided into different registry units.

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