The Shandong Quality Inspection Center received the CNAS’s (China National Accreditation Service for Conformity Assessment’s) accreditation on October 24, being the first laboratory accredited for GLP (Good Laboratory Practice) in China to conduct biocompatibility testing on medical devices.
Biocompatibility testing is part of the overall assessment of the medical device and reflects the effects on a biological system to ensure the patient’s safety.
For the registration of medical devices in China, biocompatibility test reports conducted and issued by a GLP-compliant laboratory outside of China are the only non-local tests accepted by NMPA. In such cases, the GLP certificate is also required as part of the dossier submission. As Chinese laboratories also now obtain GLP certification it will make more sense for companies to conduct all testing including biocompatibility within China.
By Jacky Li. Contact Cisema if you would like to learn more.
