Brief Introduction to Regulatory Documents of European and American Drug-Device Combinations and Enlightenment / 中国医疗器械杂志

ABSTRACT

This paper briefly introduces the recent regulatory regulations issued by the European Union and the United States on the drug-device combinations. The contents include the definition of drug-device combinations, the attribute definition process, the registration requirements, the review and approval procedures, the management of production systems, and the post-marketing safety supervision. Some inspirations have been obtained from them for reference by the regulatory authorities.