In order to fully implement the primary responsibility of medical device registrants for quality and safety, further strengthen the supervision and administration of entrusted production by registrants, and effectively prevent and control quality and safety risks of medical devices, the China Association for Medical Devices Industry (CAMDI) successfully held a training session on the policy requirements regarding the supervision and administration of entrusted production by medical device registrants in Nanjing on July 3.
Leaders and experts from the Department of Medical Device Supervision of National Medical Products Administration, Shanghai Municipal Medical Products Administration and Zhejiang Medical Products Administration were invited to provide authoritative, systematic and accurate training. Yang Xiaofang, Deputy Secretary General of CAMDI, and Chen Heping, Deputy Director of Jangsu Medical Products Administration, attended the session and made a speech. The comrades in charge of regulations, production, registration and other departments of manufacturers in the medical device industry participated in the training for in-depth and systematic study of policy requirements.
The training focused on the supervision and administration requirements regarding the entrusted production by registrants, the regulations on the implementation of primary responsibilities for quality and safety by enterprises, the frequently asked questions about the quality management system of registrants who entrust the production, the practice of cross-region medical device supervision and administration, and other aspects, and brought authoritative and accurate training content for the medical device industry. It received high praise from participants and played a positive role in strengthening the publicity and implementation of regulations and reaching a consensus in the industry.