The meeting mainly focused on the collection of the feedback of the management counterparts on the technical reviews for medical devices and the development and construction of electronic declaration information system for medical device registration. The meeting aimed to listen to the opinions and suggestions of the management counterparts on the technical reviews and evaluations, collect the feedback of technical review providers, and publicize the informational electronic declaration of medical device registration so as to improve the quality and efficiency of the registration declaration and technical reviews.
In the meeting, the CMDE reported its general achievements in 2017 and work ideas in 2018 and pointed out that it has taken enterprises as important service objects, and actively listened to customer feedback, optimized the review and approval, and gradually deepened the requirements of the reform of review and approval. The construction of the electronic declaration system for medical device registration is one of the important tasks required by the Advice on Deepening the Reform of Evaluation and Approval System to Encourage Innovation in Drugs and Medical Devices proposed by the General Office of the CPC Central Committee and the General Office of the State Council. The CMDE has set up a special task force for development and construction, undertook the related work of technology development and management, formulated the technical requirements for electronic declaration, perfected the information construction of medical device review and approval, and gradually realized the electronic submission of various registration applications.
Representatives of participating enterprises all expressed their recognition on the review and approval conducted by the CMDE in 2017, especially the high efficiency and timeliness of the review and approval, the diversity of communication and exchange methods, professional training service and outstanding review and guidance capabilities. Subsequently, the representatives of enterprises and the members of the task force discussed the theme of the meeting, including the proposal of optimizing and simplifying the examination and approval of registration renewal, increasing the number of corporate consulting services, gradually completing the list of IDE items, establishing sample libraries for clinical trials or evaluation centers, improving the construction and management of the registration system of electronic declaration system for medical device registration and the opinions and suggestions for the CDME of the CFDA on unifying the review and approval conducted by provincial administrations all over the country through the quality management system. The task force had Q&A and exchange based on the opinions, timely summarized, sorted out and studied relevant opinions and suggestions.
More than 30 people, including Lu Zhong, deputy director of the CMDE of the CFDA and his office members, representatives from Office of Comprehensive Services, Quality Management Office and domestic and overseas enterprises attended the meeting. The CAMDI organized more than 20 corporate members to participate in the meeting and actively get involved in the discussion. The CAMDI also delegated representatives to attend the meeting and expressed the opinions and voices of the enterprises on the relevant contents.