On January 23, 2024, CMDE publicly sought opinions on the “Guideline for the Technical Review of the Registration of Phacoemulsification and Vitrectomy Devices and Accessories in Ophthalmology (Revised 2023).”
This guideline aims to assist registration applicants in standardizing the preparation and writing of registration application materials for ophthalmic phacoemulsification and vitrectomy devices and accessories. It also serves as a reference for the technical review department during the assessment of registration application materials.
The guideline outlines essential criteria for ophthalmic phacoemulsification and vitrectomy equipment and accessories. Registration applicants are required to evaluate applicability based on the specific characteristics of their product.