Comments from medtech stakeholders in all geographies are invited until 28 September on the Chinese State Food and Drug Administration’s draft Medical Device Administration Law (MDAL). The law is set to replace the medical devices supervision and administration regulation issued since 2000, most recently No. 739 in 2021.
It would be China’s first national level law governing medical devices. The MDAL would have purview over the total medical device lifecycle
By this initiative, the National Medical Products Administration (NMPA) is seeking to elevate devices legislation to a higher order, said Katherine Wang, life sciences partner at law firm Ropes & Gray