Will the Animal Test be Required for Your Medical Devices Before the Clinical Trials?

According to the Medical Device Registration Technical Guideline, some medical devices need to do the animal test before the clinical trials. The medical device animal tests is to verify the product safety but not the efficiency. And it is not for all the medical devices. Generally, the implant products, medical devices that may have radiation, injectable filling agent and etc. are required to do the animal test because these products are high-risk level and may cause great harm to the human body when problems arise.

Animal test is part of the biological evaluation. Currently, medical device biological evaluation is based on the standard GB/T 16886- ISO 10993.This standard standardized the biological tests and non-experimental evaluation of the medical device biological evaluation. The test part includes in vivo experiments and non-vivisection experiments (ex: vitro cell).

The indexes of the in vivo experiments

• Genotoxicity, carcinogenicity and reproductive toxicity experiments
• Blood reciprocity reaction
• Local reaction experiments after implantation.
• Qualitative and quantitative framework of potential degradation products
• Stimulation and delayed hypersensitivity reaction experiment
• Systemic toxicity experiment
• Degradation products and filter toxicity research.

The qualification of the biological evaluation
The biological evaluation should appoint the qualified institutions that are the GLP authenticated institutions. Otherwise, the evaluation center will not admit the validity of the reports. And the biological evaluation reports provided by the oversea labs should attach the quality assurance documents that state the reports meet the requirements of the GLP laboratories.

*If you have any comments or questions, please contact us at md@cirs-group.com