The NMPA published the revised version of “Medical Device Animal Study Guideline Part 1: Decision-making Principles” and “Medical Device Animal Study Guideline Part II: Test Design and Quality Assurance”.
Animal study is to evaluate the safety and efficacy of medical devices. In the design process, after implementing risk reduction control measures, the effectiveness of risk control measures needs to be verified and validated.
Key Issues for Medical Device Animal Studies
It must comply with the 3R+DQ principle, i.e. Replacement, Reduction and Refinement, Design and Quality.
Necessity to carry out an animal study
Applicants shall consider to use non-living objects, computer simulation and other methods to replace animal study, and make full use of existing animals of similar products test data or evidence such as performance comparison with similar products on the market which reduces the number of animal tests.
Animal study v.s. biological evaluation research
The guidelines do not replace the technical documents related to the biological evaluation of medical devices such as the GB/T 16886 standards. Some biological risks can be evaluated in animal studies but the content of the evaluation must meet the requirements of biological evaluation related technical documents such as the GB/T 16886 standards.
The applicant should strictly control the quality of the test, truthfully record the test results, and have a professional review the results systematically.
- Device under test
It should be a sample produced under a quality management system. Generally, it is a final product. Alternative samples can be used if the animal anatomy is special
Product design changes can be made. It is necessary to analyze the impact of the changes on the animal experiment process, test results and conclusions, and redo the animal study if necessary.
- Animal of choices
The following factors should be considered when selecting experimental animals (including but not limited to):
- Meet the requirements of the test purpose;
- The structure (such as anatomical structure, size), function, metabolism and disease characteristics, biological response, etc. are similar to the human body;
- Sensitive to evaluation indicators;
- Animal basic elements such as gender and specifications do not affect the results and conclusions of animal experiments.
- Number of animals
The number of animals should be sufficient to ensure that the test results are reliable and conform to the 3R principle. Statistical methods may not be used to estimate the number. If under the same test conditions, the evaluation results between individual animals have greater variability, the reasons for the variability, such as operation methods, product quality, etc., should be analyzed, and the number of animals should be increased when appropriate to obtain more reliable conclusion.
- Observation time
The applicant should set sufficient and different observation time points based on factors such as the purpose of the product test, the working principle, the expected way and time of contact with the human body, and the time required to achieve a steady state of biological response. Generally, it can include preoperative, intraoperative, and postoperative observations. Immediately, short-term after operation, mid/long-term after operation, etc.
In the research plan, it is necessary to clarify the specific evaluation method of the evaluation index, the observation time point and frequency of the specific evaluation index. Evaluation indicators should have scientific and objective evaluation standards.