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:

Test ItemChinese Standard NumberInternational Standard NumberReproductive toxicityGB/T 16886.3-2019ISO 10993-3:2014Bacterial recovery mutationGB/T 16886.3-2019ISO 10993-3:2014Chromosome aberrationGB/T 16886.3-2019ISO 10993-3:2014Mouse lymphoma cell (TK)
gene mutationGB/T 16886.3-2019ISO 10993-3:2014MicronucleusGB/T 16886.3-2019ISO 10993-3:2014Blood coagulationGB/T 16886.4-2003ISO 10993-4:2017HematologyGB/T 16886.4-2003ISO 10993-4:2017PlateletGB/T 16886.4-2003ISO 10993-4:2017ThrombosisGB/T 16886.4-2003ISO 10993-4:2017Complement activationGB/T 16886.4-2003ISO 10993-4:2017HemolysisGB/T 16886.4-2003ISO 10993-4:2017CytotoxicityGB/T 16886.5-2017ISO 10993-5:2009Subcutaneous implantGB/T 16886.6-2015ISO 10993-6:2016Muscle implantGB/T 16886.6-2015ISO 10993-6:2016Bone implantGB/T 16886.6-2015ISO 10993-6:2016Brain implantsN.A.ISO 10993-6:2016Residues of ethylene
oxide sterilizationGB/T 16886.7-2015ISO 10993-7:2008/Amd.1:2019Qualitative and quantitative framework for potential
degradation productsGB/T 16886.9-2017ISO 10993-9:2019Penisto stimulateGB/T 16886.10-2017ISO 10993-10:2010SensitizationGB/T 16886.10-2017ISO 10993-10:2010Rectum stimulusGB/T 16886.10-2017ISO 10993-10:2010Vaginal stimulationGB/T 16886.10-2017ISO 10993-10:2010Intradermal reactionGB/T 16886.10-2017ISO 10993-10:2010Skin irritationGB/T 16886.10-2017ISO 10993-10:2010Eye irritationGB/T 16886.10-2017ISO 10993-10:2010Oral stimulationGB/T 16886.10-2017ISO 10993-10:2010Acute systemic toxicityGB/T 16886.11-2011ISO 10993-11:2017Subacute toxicityGB/T 16886.11-2011ISO 10993-11:2017Subchronic toxicityGB/T 16886.11-2011ISO 10993-11:2017Chronic toxicityGB/T 16886.11-2011ISO 10993-11:2017PyrogenGB/T 16886.11-2011ISO 10993-11:2017Qualitative and quantitative characterization of polymer degradation productsGB/T 16886.13-2017ISO 10993-13:2010Qualitative and quantitative analysis of degradation
products of ceramicsGB/T 16886.14-2003ISO 10993-14:2001Qualitative and quantitative characterization of degradation products of metals and alloysGB/T 16886.15-2003ISO 10993-15:2019Study and design of toxicity
kinetics of degradation products
and leachable substancesGB/T 16886.16-2013ISO 10993-16:2017

Contact Cisema if you would like to learn more.