In order to implement the spirit of General Secretary Xi Jinping’s remarks at the symposium on deepening the coordinated development of the Beijing-Tianjin-Hebei Region (“BTH Region”), further improve the quality and safety regulation of medical devices in the BTH Region and promote the high-quality development of the medical device industry in the BTH Region, drug regulators in Beijing, Tianjin and Hebei jointly issued the Measures for Cross-Regional Collaborative Regulation of Medical Device Production in the Beijing-Tianjin-Hebei Region (for Trial Implementation) (“Measures”) on July 28, 2023 in accordance with related regulations and rules on the regulation of medical device production and the requirements of related documents including the Regional Cooperation Agreement on the Scientific and Collaborative Regulation of Medical Devices in the Beijing-Tianjin-Hebei Region.

The strategy of coordinated development of the BTH Region has been accelerated in recent years. Beijing, Tianjin and Hebei have advanced deep cooperation in the medical industry by improving regulatory systems and mechanisms and co-building a platform for sharing regulatory resources and have made significant achievements in the high-quality development of the biomedical industry. To adapt to the new regulatory situation, drug regulators in the three places actively guide and support medical device registrants in using the location advantages of the BTH Region to fully promote the integrated development of the medical device industry in the three places. By defining the workflows and specific requirements in terms of collaborative regulation of medical devices by drug regulators in the three places, including supervision and inspections, joint interviews, joint training, risk-related consultation and information notifications, the Measures will further strengthen the building of a collaborative regulation system for medical device production in the three places, promote the sharing of regulatory information and training resources and effectively drive the regulation of medical device production in the BTH Region to go higher, deeper and wider.

In the next step, according to the Measures, the Beijing Municipal Medical Products Administration will earnestly implement related work requirements, further strengthen joint training and joint inspections in the three places, unify regulatory standards, improve the efficiency of scientific regulation and jointly advance the high-quality coordinated development of the medical device industry in the BTH Region.

Source: Beijing Municipal Medical Products Administration