Sichuan Testing Center for Medical Devices and Biomaterials, an independent and self-managed legal entity, was authorized by State Food and Drug Administration and Certification and Accreditation Administration of the People's Republic of China in 2003 and 2004, respectively. The primary responsibility is evaluating Class III and some Class II medical devices. We are entitled to issue medical device evaluation reports with legal authority.

The center follows the rule “the quality, the priority” and provides objective, scientific and accurate testing and evaluation. The quality assurance system is based on the Chinese national standard: GB/T 15481 general requirements for the competence of testing and calibration laboratories. The center is highly efficient in evaluation process and can issue the reports punctually according to the contracts. We also provide consulting services on product testing, standards formulation and modification.

The center has an office, physical-chemical testing labs and biological property testing labs. Our GLP standard laboratories cover an area of 1442 square meters, including SPF standard animal lab and class 100,000 clean rooms. The center is equipped with more than 80 instruments for physical-chemical testing, histology, cell biology and molecular biology studies. It meets the high standard for evaluation of medical devices and biomaterials.

All our evaluation staffs are well trained and most of them have Master or Ph. D degrees in science or in engineering. The director of biological property testing lab has more than 40 years experience in biomaterials evaluation with an excellent academic reputation. The center can conduct all necessary biocompatibility tests and evaluations according to GB/T16886 and ISO10993 standards, as well as physical and chemical tests.