NMPA Interpretation On Review Guideline Of Animal Studies For Medical Device Registration (Final)

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.

Key Issues for This New Animal Study Guideline

1. Applicable Scope

This Guideline is not applicable to the study on non-living animals, isolated tissues or organs, and in vitro diagnostic reagents regulated as medical devices.