Katherine Wang Widely Cited on China’s Draft Medical Device Administrative Law

China’s National Medical Products Administration (NMPA) recently requested public comments on its draft Medical Device Administrative Law (MDAL), the first statute of its kind. Ropes & Gray life sciences partner Katherine Wang (Singapore) has been widely cited on this issue.

“By this initiative, the National Medical Products Administration (NMPA) is seeking to elevate devices legislation to a higher order,” Katherine said in a Medtech Insight article titled "China Moves From Administrative Orders to Medtech Law – Consultation Underway." She added that in terms of legislation, devices will be on an equivalent level to pharmaceuticals, an industry sector already governed by an administrative law.

In a Q&A interview in the November issue of the Journal of Medical Device Regulation, Katherine discussed the purpose of the draft law, why it is important to manufacturers, incentives, the importance placed on compliance with compulsory product standards, and other noteworthy proposals.

In a China Business Law Journal article titled “China drafts top-legal level medical device law,” Katherine outlined that within China, local legal agents are responsible for post-approval compliance of medical devices. Their obligations range from annual reporting, adverse event reporting and monitoring, product recall and co-ordination with the NMPA on overseas inspections, she highlighted.

Katherine’s remarks follow an article she authored titled “China’s NMPA Requests Public Comments on its First Medical Device Law – Three Key Points,” which was re-published by Medical Buyer.