New NMPA Review Guideline Of Animal Studies For Medical Device Registration
2021-11-27
On Sep 27, 2021, NMPA published a new Review Guideline of Animal Studies for Medical Device Registration: Part 1 Determination Criteria (2021 Amendment) and Part 2 Animal Study Design and Conduct Quality Assurance, which have been effective since Sep 18, 2021.
Background
Animal study for medical device is to select animals that meet the study requirements, according to the study purpose, carry out product feasibility and / or safety and / or effectiveness research under the provisions of the pre-designed study protocol, observe and record the reaction process and results of animals, so as to confirm the role and impact of medical devices on life activities. In the risk management activities of design and development, the effectiveness of risk control measures shall be verified / validated after the implementation of risk reduction control measures. Animal study is one of the means to validate the effectiveness of risk control measures and an important evidence module to evaluate the safety and effectiveness of medical device.
NMPA has interpreted the key issues for this new animal study guideline from 8 aspects as below:
Applicable Scope
General Principles of Animal Study
Determining Whether an Animal Study Is Necessary
Purpose of Animal Studies
The Relationship Between Animal Study and Biological characteristics
Attachments of this Guideline
Animal Study Protocol Design 7.1. Study Device 7.2. Study Animals 7.3. Animal Sample Size 7.4. Observation Time 7.5. Evaluating Indicator
