Guidelines For Technical Review Of Registration Of Medical Devices For Human In Vitro Assisted Reproductive Technology(Final)

The guideline is intended to provide technical guidance to the drug regulatory authorities on the technical review of registration application materials, and also to provide a reference for registration applicants to apply for registration of human in vitro assisted reproductive technology fluids.

The guideline is considered as a general requirement for human in vitro assisted reproductive technology fluids. Registration applicants should enrich and refine the contents of registration application materials based on the characteristics of specific products, and determine whether the specific content is applicable based on the characteristics of specific products.

The guideline is a technical guidance document for registration applicants and reviewers. It does not include administrative matters involved in registration approval, nor is it enforced as a regulation. Other scientifically reasonable alternatives can also be used if available, but detailed research data and verification data are required to be provided.