NMPA Key Laboratory for Dental Materials
The NMPA Key Laboratory for Dental Materials was established and approved by the National Medical Products Administration (NMPA) as the first Key Laboratory in the field of dentistry in China, since July 2019. This Key Laboratory is supported by Peking University, administered by the Peking University School of Stomatology, and the core unit of this Key Laboratory is Dental Medical Devices Testing Center of Peking University School of Stomatology, which background is National Food and Drug Administration Medical Device Quality Supervision and Inspection Center of Peking University established in 1980. Professor Deng Xuliang serves as the first director of the Key Laboratory.
The main objective of the Key Laboratory is to provide technical support for the supervision and management of dental medical devices in China, with a focus on (i) solving major scientific problems in evaluation techniques for dental materials, (ii) improving the supervision quality of dental medical devices and establishing connection between dental materials evaluation and clinical application, so as to realize the efficient use of advanced evaluation techniques in dental medical devices supervision, (iii) promoting the clinical transformation of scientific and technological achievements, (iv) developing new medical device evaluation techniques, and (v) improving effective supervision capacity in the field of dental medical devices in China.
To facilitate the realization of developmental goals and research directions, the Key Laboratory has set up the following four major technology platforms:
1. The platform of key performance evaluation technology of novel dental materials.
2. The platform of performance evaluation technology of dental materials within simulated oral service environment.
3. The data center for key performance of dental materials.
4. The platform of dental materials standard library and evaluation criterion.
The Dental Medical Devices Testing Center of Peking University School of Stomatology, as the core unit of the Key Laboratory, has extensive experience in the evaluation and the service of regulation for dental materials. The center is the only institution in China that specializes in the inspection, evaluation and supervision of dental materials since its establishment in 1980s. To date, it is also the only dental materials testing institution established in a university in China, which is certificated by the China National Certification and Accreditation Administration (CMA) and China National Accreditation Service for Conformity Assessment (CNAS).
For nearly forty years, the center has focused on quality evaluation, methodology research and the development and revision of relevant national and pharmaceutical industry standards for dental materials, which provides strong technical support for dental medical device supervision, the pre- and post-market quality evaluation of dental materials for NMPA and for industrial R&D. The National Dental Materials, Devices and Equipments Standardization Technical Committee has been established and has formulated more than 80 national and industrial standards for dental materials, as well as established a standard system for dental materials, devices and equipment in China. The center performs the work of "ISO/TC 106 Dentistry" on behalf of China and participates in international standardization activities, promoting the international standards transformation.