On August 28, 2024, China's National Medical Products Administration (NMPA) released the Draft for Comments on the Medical Device Administration Law for public consultation. The deadline for submitting feedback is September 28.

The Draft covers multiple stages of the medical device lifecycle, including research and development, manufacturing, distribution, and usage, along with standards, classification, safety monitoring, and recall procedures. It places particular emphasis on fostering innovation and enhancing regulatory oversight throughout the entire lifecycle of medical devices.

The Medical Device Administration Law replaces the Regulations on the Supervision and Administration of Medical Devices, which were administrative regulations with limited legal strength. The new law, passed by the National People's Congress, brings enhanced legal weight and enforcement power. It addresses previous legal gaps and improves the regulatory framework, providing a more robust legal basis and support for the industry's development. The introduction of the new law marks the beginning of stricter regulatory oversight while also offering clearer guidance for innovation, research and development, and market entry in the medical device sector.