The PRC Regulations on the Supervision and Administration of Medical Devices (“Regulations”) have recently been amended and promulgated by the State Council. The new Regulations, which will be effective from 1st June 2021, provide some important changes of which the medical device industry should be aware.
Under the current Regulations, a license to manufacture medical device is only granted to the Market Authorization Holder (“MAH”) itself. However, a pilot scheme has been in place since 2017, first in the Shanghai Free Trade Zone and subsequently extended to other regions, permitting MAHs to contract out their manufacturing activities. The new Regulations now widen that pilot scheme to a country-wide basis, enabling those without manufacturing capability, e.g. pure research institutions, to commercialize their inventions by outsourcing production.
The new Regulations also simplify and optimize the process for obtaining marketing approval. Previously, clinical testing could be exempted but clinical evaluation (which, if clinical testing was exempted, could be based on literature research and/or clinical data from predicate devices) is mandatory for all registration applications. The new Regulations broaden the exemption, allowing clinical evaluation also to be dispensed with if certain criteria are met. In addition, conditional approval of medical devices is introduced for rare diseases, life-threatening diseases without other effective treatment, and emergency use in case of major public health events.
In line with the national aim of promoting innovation, the new Regulations give priority to novel medical devices in the approval process. Further, the legality of laboratory developed tests is confirmed, provided it is used internally by the medical institute that develops the test and there has not been any in vitro diagnostic product approved in the mainland achieving the same purpose.
The new Regulations also modify and refine several other aspects in the medical device regulatory regime, including relaxing the strict importation rules for innovative medical devices that have not been approved abroad, emphasizing the compliance responsibilities of MAHs, clarifying rules relating to online sales of medical devices, increasing penalties and extending punishment for violations to legal representatives and other responsible officers in an offending company.