China News Service: 

We noticed that the NMPA publicly solicited opinions in August on the draft Medical Devices Management Law. Could you explain the initial motivation and significance behind the formulation of this specific law? Thank you.

Lei Ping: 

Thank you for your question, and for your interest in and support for the NMPA's legal development efforts. In recent years, the NMPA has made rapid progress in its legal framework. We have fully revised the Drug Administration Law, enacted the world's first comprehensive Vaccine Administration Law, and revised the Regulations on the Supervision and Administration of Medical Devices and the Regulations on the Supervision and Administration of Cosmetics, thereby completing the key pillars of China's pharmaceutical regulatory system.

In order to ensure the safety and efficiency of medical devices and to promote high-quality industry development to better meet the public's demand for high-quality medical devices, the 14th NPC Standing Committee has included the Medical Devices Management Law in its legislative plan.

Elevating the management of medical devices from administrative regulations to a law not only raises the legal status, but also enhances the content. There were three main considerations in drafting the Medical Devices Management Law. First, it meets the practical need to promote the high-quality development of the medical devices industry. In recent years, China's medical devices industry has shown strong growth, with a compound annual growth rate exceeding 10% for many years. A specialized law is necessary to elevate the industry to a national strategic level, providing comprehensive and systematic regulations from technology investment, financial support, capacity building, industry standards and academia-industry collaboration, to industry-wide coordination. Second, it is crucial for establishing a comprehensive and systematic regulatory framework. This specialized law will provide a more complete and authoritative legal foundation for governing the medical devices industry. Third, it aligns with the requirements of China's participation in international exchanges and cooperation. A dedicated law will help synchronize with international medical device management laws and better leverage China's role and position in relevant international organizations.

The draft Medical Devices Management Law is currently open for public consultation, and we encourage everyone to offer valuable suggestions to help shape this new law. Together, we can ensure the safety of medical devices for the public. Thank you.