Member Article

On August 28, 2024, the National Medical Products Administration (NMPA) released the Medical Device Administration Law (Draft for Comment) (hereinafter referred to as the "Draft") for public comments. This move comes within a year of the Standing Committee of the National People's Congress's adding the Medical Device Administration Law to its legislative plan on September 7, 2023, reflecting the regulatory body's efficient and high-quality advancement of the legislation, indicative of its commitment and diligence.

The forthcoming Medical Device Administration Law is anticipated to significantly impact the medical devices industry. Unlike the drug sector, which is governed by the Drug Administration Law, China's medical devices regulation has primarily relied on the State Council's Medical Device Supervision and Administration Regulation, an administrative regulation, not a law. The lower legal hierarchy of administrative regulations has limited the depth and refinement of the regulatory framework. The new Medical Device Administration Law is expected to provide a more authoritative regulatory framework for the industry.

Having contributed to preliminary legislative study and consultation for the Draft, we analyze and interpret several regulatory changes and key points in the Draft, drawing on our team's prior research. We aim to provide useful insights for industry stakeholders regarding the evolving regulatory landscape in China's medical device sector.