ARTICLE SUMMARY:
The National Medical Products Administration in China recently circulated a proposal that would elevate regulation of devices in the country to the level of law, add some stricter requirements and penalties, and also make changes to encourage adoption of more innovative devices.
The Chinese government plans to embed its oversight of medical devices into law with a new proposal that doubles down on China’s use of mandatory domestic standards and adds stricter noncompliance penalties, but also seeks to streamline the launch of new products.
China’s National Medical Products Administration published a draft Medical Device Administrative Law in late August that would create the country’s first legal statute defining regulatory oversight of devices. Up until now, the framework has been defined in regulation (one step down from law in terms of legislative authority). NMPA has been rapidly updating and augmenting its device framework in recent decades. Its last major update was in 2021, flanked by a continuous stream of policies and guidelines that flesh out clinical and premarket pathways, as well as provisions for postmarket oversight, inspections, and enforcement. Now, the government has decided the approach should be spelled out in a law with approval from the National People’s Congress.
