Dental Medical Devices Testing Center
Dental Medical Devices Testing Center of Peking University School of Stomatology is a full-time inspection institution authorized by General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China, Certification and Accreditation of the People's Republic of China, China National Accreditation Service for Conformity Assessment and State Administration for Market Regulation, enjoying the status of an independent legal person. It is a professional inspection institution of dental device that integrates the research and quality evaluation of medical devices.
At present, the center has established a quality management system which meets the requirements of ISO/IEC 17025 international standards. It is approved by China Food and Drug Administration for medical equipment inspection, laboratory and qualification certification. It obtained the laboratory accreditation certificate of China National Accreditation Service for Conformity Assessment Certification and Accreditation of the People's Republic of China "qualification certification certificate" and Qualification certificate of inspection and appraisal institution for import and export commodities of General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China.
As a technical support agency for medical device quality supervision, it is responsible for the physical, mechanical, chemical and biological performance testing and quality evaluation of domestic and imported medical devices. Products include dental materials, dental instruments, biomaterials, orthopedic instruments, oral care and oral healthcare products and other medical devices. The types of inspection include registration inspection, consignment inspection and national market quality supervision and testing. Up to now, 126 kinds of medical device products have been tested, 1409 items of inspection and 430 standard testing methods have been established in our center.
At the same time, the center also provides the external services of technical evaluation and standard consulting. It undertakes the relevant scientific research work such as quality appraisal, inspection technology development, and property evaluation method in dental materials research and product development process.