Guangdong Medical Devices Quality Supervision and Inspection Institute

Guangdong Medical Devices Quality Supervision and Inspection Institute (Guangzhou Medical Devices Quality Supervision and Inspection Center of the National Medical Products Administration) (hereinafter referred to as "Guangdong Medical Devices Institute") is a public institution directly under the Guangdong Food and Drug Administration, managed with reference to civil servant regulations, with independent legal person status. It is the largest and most authoritative medical device inspection institution in South China, and also performs the duties of the Guangdong Quality Supervision Medical Device Inspection Station and the Guangdong Quality Supervision Drug Packaging Product Inspection Station.

The Guangdong Medical Devices Institute has passed the laboratory accreditation of the China National Accreditation Service for Conformity Assessment (CNAS), the national metrology certification, and the qualification authorization and metrology certification of the Guangdong Provincial Bureau of Quality and Technical Supervision. It is a designated quality inspection institution for medical devices by the National Medical Products Administration, and legally undertakes the inspection of medical device products and quality supervision inspections at the national, provincial, and municipal levels. It is also a testing laboratory for CE certification products authorized by TUV PS Germany. The Guangdong Medical Devices Institute is also one of the testing and appraisal institutions for scientific and technological achievements in Guangdong Province. It has established a comprehensive quality management system in accordance with CNAS-CL01:2006 "Accreditation Criteria for the Competence of Testing and Calibration Laboratories" (ISO/IEC 17025:2005) and the "Assessment Criteria for Laboratory Qualification Recognition" (Guo Ren Shi Han [2006] No. 141). Its testing capabilities cover various fields such as packaging materials, containers, machinery, chemistry, physics, medical electronics, electrical safety, medical materials, biological performance, electromagnetic compatibility, ultrasound, and optics.

The Guangdong Medical Devices Institute has a Packaging Materials and Containers Testing Center, which is the largest and most capable packaging materials inspection institution in South China. It legally undertakes the inspection of packaging material and container products for food, health food, cosmetics, drugs, and medical devices, as well as the inspection of clean rooms (areas), the compatibility testing of drug packaging materials with drugs, and the formulation and revision of standards for packaging material and container products and clean rooms (areas), scientific research, and technical review.

In addition, the Guangdong Medical Devices Institute is the secretariat unit of the National Technical Committee for Standardization of Medical Extracorporeal Circulation Equipment, the National Technical Committee for Standardization of Sterilization Technology and Equipment, and the Dental Equipment and Devices Subcommittee of the National Technical Committee for Standardization of Dental Materials and Dental Instruments and Equipment. It is responsible for organizing the formulation, revision, conversion, verification, and training of standards for three categories of medical devices: medical extracorporeal circulation, dental equipment, and sterilization equipment. At the same time, it is also the secretariat unit of the Medical Device Quality Management Committee of the China Pharmaceutical Quality Management Association, the Guangdong Provincial Technical Committee for Standardization of Medical Instruments and Equipment, the Pharmaceutical Packaging Materials Professional Committee of the Guangdong Pharmaceutical Association, the Guangdong Medical Device Management Society, and the Medical Device Professional Committee of the Guangdong Health Economics Association.