On the afternoon of October 18, the Center for Medical Device Evaluation convened the staff meeting to deploy the implementation of the Advice on Deepening Reform of Examination and Approval System and Encouraging Innovation in Drugs and Medical Devices (the Advice). Wang Zhexiong, the director of Medical Device Registration Department of CFDA, was invited to interpret the drafting background of the Advice, the content of medical devices examination and approval system reform. Director Sun Lei mobilized and deployed the implementation of the Advice and the works of the Center.
Sun Lei emphasized that since the implementation of the Opinion on Reform of Examination and Approval System for Drug Medical Devices in August 2015,a series of reforms have been implemented, with continuous reform bonus, and the issuance of the Advice provided another programmatic document for deepening the reform of examination and approval system for medical devices, and becomes the guideline for present and future reform of examination and approval system for medical device in a certain period with 36 reform measures in 6 parts concerning the prominent challenges to the innovation of drugs and medical devices for long-term system construction.
Sun Lei required that the staff in the Center shall recognize the importance and necessity of deepening reform and encouraging innovation, and unify the ideas, strengthen the organization leadership, enhance training and publicity and increase the sense of responsibility, urgency and mission of examination and approval of medical devices, and spare no effort to the four work parts related to medical devices. First, deepen the reform of evaluation mechanism. Establish a clinical practice-oriented project manager system and a project team evaluation system, and adjust the internal organization of the Center and construct an evaluation team. Continue to implement the Quality Management Practice for Evaluation of Medical Devices and explore and establish a filing review system to simplify the evaluation procedure. Complete the clinical evaluation, develop a pre-registration meeting communication system, standardize the evaluation report format, publish the technical evaluation report gradually and accept the social supervision. Second, encourage the research and development of innovative medical devices. Complete the special and prior innovation approval procedures, and the pre-registration communication and prior evaluation of the products of national key S&T Special Projects, national key R&D plan and clinical trial approval. Accelerate the examination and approval of the product in clinically urgent. Third, enhance the technical support of examination and approval. Intensify the preparation and amendment of guideline, and establish a guideline system for technical review of medical devices. Take active part in the preparation and amendment of laws and regulations and international seminar to further improve the law and regulation system for medical devices in China. Fourth, enhance the informatization construction of examination and approval. Optimize evaluation system for reconstructive medical devices to realize electronic application of registration and examination and approval. Establish and improve the product and register-centered registration database of medical devices and the marketed varieties file.