Guidelines for registration review of alginate dressings（Draft）
On April 28, China NMPA.CMDE issued the draft guidance “Guidelines for registration review of alginate dressings”. CMDE call for public comments on the draft guidance before 5th June.
Draft for Comments
Guidelines for registration review of human papillomavirus (HPV) nucleic acid detection and genotyping reagents (2024 revised draft)
On April 23rd, China CMDE issued the draft guidance “Guidelines for registration review of human papillomavirus (HPV) nucleic acid detection and genotyping reagents (2024 revised draft)”. CMDE called for public comments on the draft guidelines before May 6th.
Guidelines for Registration Review of Acellular Matrix Soft Tissue Wound Repair Materials Products (Draft)
On April 11st, 2024, China CMDE. NMPA issued “Guidelines for Registration Review of Acellular Matrix Soft Tissue Wound Repair Materials Products (Draft)”. CMDE called for public comments on the guidelines before May 10th.
China CMDE call for public comments on 3 Draf Guidelines
On March 25, 2024, China CMDE has compiled three medical device registration review guidelines: ” Guidelines for Registration Review –Antibacterial Performance Evaluation of Orthopedic Implants”, ” Guidelines for Registration Review –Type I Collagen Cartilage Repair Products”, and ” Guidelines for Registration Review –Oral Repair Membranes”. CMDE called for public comments on these guidelines before April …
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“Guidelines for Registration Review — Ophthalmic Phacoemulsification and Vitrectomy Equipment and Accessories” (Draft)
On January 23, 2024, China CMDE.NMPA issued the draft guidance “Guidelines for Registration Review — Ophthalmic Phacoemulsification and Vitrectomy Equipment and Accessories ” . CMDE called for the public comments on the draft guideline before February 22, 2024.
“Guidelines for Registration Review — Clinical Trials of Peripheral Drug-Coated Balloon Dilatation Catheters ” (Draft)
On February 5, 2024, China CMDE.NMPA issued the draft guidance “Guidelines for Registration Review — Clinical Trials of Peripheral Drug-Coated Balloon Dilatation Catheters ” CMDE called for the public comments on the draft guideline before February 26, 2024.
“Guideline for Registration and Review —Clinical Evaluation of IVD Reagents for Colorectal Cancer Screening” (Draft)
On February 6, 2024, China CMDE.NMPA issued the draft Guidance “Guideline for Registration and Review — Clinical Evaluation of IVD Reagents for Colorectal Cancer Screening” (Draft). CMDE called for the public comments on the draft guideline before March 4, 2024.
“Guidelines for Substantial Equivalence Review — Clinical Evaluation of RF/Microwave Ablation Equipment” (Draft)
On February 8, 2024, China CMDE.NMPA issued the draft guidance “Guidelines for Substantial Equivalence Review — Clinical Evaluation of RF/Microwave Ablation Equipment”. CMDE called for the public comments on the draft guideline before March 8, 2024.
China CMDE Releases Draft of Guideline 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 …
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The China CMDE has released a draft of the Guideline for the Registration review of Monkeypox Virus Nucleic Acid Detection Reagents
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 …