What licensing regimes are put in place for commercial entities engaging in the manufacturing and trade of medical devices in China?

Generally, any commercial entity engaged in the manufacture or trade of medical devices must obtain specific licenses in addition to the standard business licenses for operating a company in China. The procedures and requirements for obtaining such industry-specific licenses significantly vary depending on the classification of the medical devices in question.

Following this, the devices themselves will need to be registered with the relevant authorities. Based on the amended State Council Order No. 650, applicants are no longer required to obtain a medical device manufacturing license prior to being able to register the devices themselves, provided they are fully in compliance with good
manufacturing practices during product design and development. This allows R&D companies to apply for product registration without first finishing construction of their manufacturing facilities, saving them a substantial amount of time and resources.