Biocompatibility Testing in China of Medical Devices: Regulatory Update

Biocompatibility testing, where required for NMPA submission, is the one test that can be done outside of China provided it complies with the GB/T 16886 and ISO 10993 standards. The scope required by NMPA may be wider than US/EU. Therefore, we receive many customer queries about biocompatibility reports and whether biocompatibility testing, if deficient, can be arranged in China instead.

Biocompatibility test reports must be issued by a GLP-compliant laboratory for the NMPA (National Medical Products Administration) registration of medical devices. Our partner laboratory is GLP accredited to offer test items that comply with the GB/T 16886 and ISO 10993 standards.

Provided your biocompatibility test is issued by a GLP-compliant laboratory, the next question is whether the testing scope is satisfactory for NMPA. NMPA frequently requires wider testing than other regulators, including testing such as for subchronic toxicity.

Cisema can prepare a customized set of applicable biocompatibility test items to support the registration of different medical devices in China. Depending on the characteristics and intended use of each individual medical device, there are cases when not all test items are required. Our service offer covers the following biocompatibility test items:

Contact Cisema if you would like to learn more.