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  • Biocompatibility Testing in China of Medical Devices: Regulatory Update

Biocompatibility Testing in China of Medical Devices: Regulatory Update

Monday, 26 July 2021 / Published in Medical Device, News, NMPA Registration in China

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

Contact Cisema if you would like to learn more.

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