During a press conference on September 13, themed “Promoting High-Quality Development,” Lei Ping, the Deputy Director of the National Medical Products Administration, discussed the recent enactment of the Medical Device Management Law. He stressed that this important initiative is designed to ensure both the safety and efficacy of medical devices while also supporting high-quality growth in the industry to better satisfy public demand for advanced medical technologies. The 14th National People’s Congress Standing Committee has made the Medical Device Management Law part of its legislative agenda.

When we inquired about the motivations behind drafting this law, Lei highlighted three main considerations. Firstly, he emphasized the urgent need for high-quality development in the medical device sector. “In recent years, China’s medical device industry has shown remarkable dynamism, with a compound annual growth rate exceeding 10% for several years,” he noted. He believes that establishing specific legislation will elevate the industry’s development to a national strategic level, covering areas such as technological investment, financial backing, capacity building, industry standards, and the integration of research and education.

Secondly, Lei pointed out that this legislation is essential for comprehensive regulation of medical device oversight. Having a dedicated law would provide systematic and authoritative legal support to manage the industry more effectively.

Lastly, he mentioned that introducing specific legislation is crucial for China’s participation in international exchanges and cooperation. “Creating this dedicated law will help align China’s medical device management with international standards, enabling our country to better leverage its position and influence in relevant international organizations,” he explained.

Overall, this comprehensive strategy aims not only to enhance the safety and efficacy of medical devices but also to position China as a significant player in the global healthcare arena.