Review, approval and post-market surveillance are three aspects of medical device supervision and administration, where the change of administration tendency and focus is always the concern of the medical device manufacturers. On the afternoon of March 18, the Drug Administration Session of 2016 CAMDI Annual Policy Meeting was held in Beijing. The deputy chief of CFDA Jiao Hong, the director of Medical Device Registration Department Wang Zhexiong, the deputy director of Medical Device Supervision Department Sun Lei and the director of Center for Medical Device Evaluation Kong Fanpu attended the meeting and delivered speeches on the focus and reform direction of medical device administration in 2017 which attracted widespread attention from medical device manufacturers.
Jiao fully affirmed the work of CAMDI. She pointed out that the CAMDI always positively reflects the demands of members, promotes industrial self-discipline, improves industrial administration, participate in the policy development of government and relevant authorities and plays an important role in the industrial development as a bridge between the government and enterprises.
When introducing the development of medical device industry, Jiao pointed out that the national safety insurance level of medical devices in 2016 was further improved and no serious quality safety events occurred during the whole year. It’s a hard-won achievement made under the common effort of governments, regulatory authorities and medical devices enterprises. 2017 is an important year to fully implement the 13th Five Year Plan. Medical device industry shall make more efforts to promote sound development of the industry and ensure the safe use of medical devices.
Jiao also pointed out that the medical device administration in 2017 will focus on three aspects.
Firstly, further deepen review and approval system reform of medical devices to encourage R&D innovation and improve the quality and efficiency of review and approval. Secondly, concentrate on risk inspection and special rectification to enhance medical device administration. Apply regulatory means to urge the enterprises to perform their social and legal responsibilities as the first persons-in-charge. Thirdly, strengthen the construction of administrative ability of medical devices to improve service quality. Strengthen the construction of talent team, institutions and information to improve administrative ability and better serve the industrial development.
Besides, Jiao put forward her expectations and suggestions on the CAMDI and medical device enterprises.
Firstly, the enterprises shall strengthen the awareness of first persons-in-charge and improve internal quality management since they are the subjects to guarantee quality safety. The enterprises shall firmly establish the concept of first persons-in-charge of product quality. They shall strictly abide by the laws and regulations and prevent risks from the sources. Besides, they shall build and run a quality management system in accordance with the quality management regulations of medical devices. No non-conforming medical devices shall be released to the market.
Since the product quality is sourced from the product design, the CFDA will strengthen the verification on medical device registration in 2017. False declaration and other violations and illegal behaviors shall be strictly cracked down. The enterprises shall perform their quality responsibility of the first persons-in-charge from the design process to maintain the sound development of the industry.
Guarantee the safety of medical devices is a tough, complex and comprehensive task. The CAMDI shall further expand its service scope and carry out propaganda and training to improve its service capacity and influence. Promote the construction of credit system of medical device enterprises. Strengthen international communication, guide medical device enterprises to expand the international market and promote the sound development of the industry.