Draft for Comments

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 …

China CMDE Releases Draft of Guideline for Comments  Read More »

Date Issued: January 18, 2024  This guideline outlines the essential criteria for monkeypox virus nucleic acid detection reagents. Applicants must assess the applicability based on the specific characteristics of their product. If the guideline is not applicable, it is imperative to provide rationale and the corresponding scientific basis. Additionally, applicants should enhance and refine the …

The China CMDE has released a draft of the Guideline for the Registration review of Monkeypox Virus Nucleic Acid Detection Reagents  Read More »