In her Ropes & Gray update, Wang highlighted the following changes proposed in the MDAL draft:

Removal of the requirement for country-of-origin approval, meaning that imported medical devices can undergo regulatory review in China in parallel with processes in other countries;
Marketing authorizations can be assigned and R&D-based medical device companies can sell rights to products along with the marketing authorizations;
Reinforcement of compulsory standards and possibility of increased penalties or punitive damages; and
Foreign marketing authorization holders to appoint China-based local legal deputies, who are jointly liable for total product life-cycle compliance (e.g. adverse event reporting and monitoring, product recalls, post-approval studies, quality management system oversight and post-approval enforcement).

China Moves From Administrative Orders To Medtech Law – Consultation Underway

Adherence To Chinese Standards Accentuated In Law That Could Be In Place In 2025