Training on Medical Device Standards and UDI-Related Policies for Medical Devices Held in Beijing

  • 2020-09-03
In order to further unify the understanding and use of medical device standards in the industry, promote the standards and norms for medical devices and their effective implementation, and implement the specific requirements of the National Medical Products Administration (NMPA) for the progress of pilot work of medical device UDI, China Association for Medical Devices Industry (CAMDI) held the “Training on Medical Device Standards and UDI-Related Policies” on August 27 to 28, 2020.

Relevant leaders from the Department of Medical Device Registration, Center for Medical Device Evaluation, Center for Medical Device Standards Management and Information Center of NMPA, Shanghai Municipal Food and Drug Administration, China-Japan Friendship Hospital and British Standards Institution, attended the training and gave lectures on related contents. Doctor Jiang Feng, Standing Vice President of CAMDI, delivered a speech in the training.

Vice President Jiang pointed out that the internationalization of unique device identification (UDI) and medical device standards was essential as the supervision concept of full life cycle of medical devices was constantly deepened. Our member enterprises were expected to benefit from this training and actively participate in the preparation and revision of medical device standards and UDI system development. CAMDI will be committed to building a smoother platform for scientific supervision of medical devices in China and giving ideas and suggestions for the development of medical devices in China.

In the two-day training, experts were invited to introduce contents related to standards, including current situations of supervision of medical device standards, administrative measures for mandatory standards, ways of enterprises to participate in standard preparation and revision, role of EU standards for medical devices in the full life cycle, and role of basic principles for safety and effectiveness in technical evaluation. The training in UDI system, thinking during UDI exploration and advancement, application practice of UDI and practical operations of UDI database in hospital environment, and other important policies and systems was also provided.

In the training, attendees listened attentively and asked questions actively, and experts were patient in interpretation, creating a harmonious atmosphere in the venue. Finally, Yang Xiaofang, Deputy Secretary General of CAMDI, summed up and thanked leaders, experts and attendees for their support. CAMDI will continue to solicit member needs and conduct targeted high-quality training to help enterprises address practical problems and promote the compliance development of the industry.