Draft for Comments

“Medical device real-world data terms and definitions” and “IVD reagents clinical trial biological sample management requirements “Industry Standard Draft

On August 9, the national centralized unit of standardized technology for clinical evaluation of medical devices issued 2 industry standard drafts “Medical device real-world data terms and definitions” and “IVD reagents clinical trial biological sample management requirements “ and called for public comments on the draft standards before October 8. For more infomation, please contact …

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Guidance for registration review of prefilled catheter irrigators(Draft)

CMDE, Draft for Comments, Latest News / By Alice

On May 11, China NMPA.CMDE issued the draft guidance” Guidance for registration review of prefilled catheter irrigators”. CMDE called for public comment on the draft guidance before June 14.

Guidelines for registration review of alginate dressings（Draft）

CMDE, Draft for Comments / By Alice

On April 28, China NMPA.CMDE issued the draft guidance “Guidelines for registration review of alginate dressings”. CMDE call for public comments on the draft guidance before 5th June.

Guidelines for registration review of human papillomavirus (HPV) nucleic acid detection and genotyping reagents (2024 revised draft)

CMDE, Draft for Comments, Guidelines, Guiding Principles / By Alice

On April 23rd, China CMDE issued the draft guidance “Guidelines for registration review of human papillomavirus (HPV) nucleic acid detection and genotyping reagents (2024 revised draft)”.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)

CMDE, Draft for Comments, Guidelines / By Alice

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

CMDE, Draft for Comments, Guidelines / By Alice

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)

CMDE, Draft for Comments, Technical Review / By Alice

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)

CMDE, Draft for Comments / By Alice

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)

CMDE, Draft for Comments, Guidelines / By Alice

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)

CMDE, Draft for Comments, Guidelines / By Alice

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.

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