On August 12, 2024, the CMDE issued 12 guidelines. The list is as follows: 1. Guidelines for registration review of hydrogel dressings 2. Guidelines for registration review of dialysate filters 3. Guidelines for registration review of single-use side hole blunt needle technology 4. Guidelines for registration review of disposable intravenous indwelling needle 5. Guiding principles …
CMDE is soliciting participation in the revision and preparation of the “Guidance for Registration Review of Platelet-rich Plasma Preparation Device” and the “Guidance on Conditional Approval of Medical Devices (2024 Revised Edition)”. It invites domestic and foreign manufacturers, research institutions, and clinical institutions with relevant experience to actively participate. Interested parties are invited to fill …
Two guidelines are solicited for participating units Read More »
China CMDE is starting the preparation of the “Guidelines for Registration Review of Carbon Dioxide Laser Therapy Devices”. Companies participating in the preparation work are now being solicited, and domestic and foreign production companies, scientific research institutions, clinical institutions, etc. with relevant work experience are invited to actively participate. Companies interested in participating in the …
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On May 27, China CMDE.NMPA releases 48 guidance documents. The list is as follows: 1. Guidelines for Registration Review of Electric Photography Flat Beds 2. Guidelines for registration review of medical gas alarm systems 3. Guidelines for registration review of air-oxygen mixer products 4. Guidelines for registration review of radiotherapy laser positioning equipment 5. Guidelines …
On April 23rd, China CMDE issued the draft guidance “Guidelines for registration review of human papillomavirus (HPV) nucleic acid detection and genotyping reagents (2024 revised draft)”.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.
On April 11, 2024, CMDE released the 2024 medical device registration review guideline preparation plan. Please refer to the following list: Plan for the formulation of guidelines for registration review of Class III medical devices No. Guiding principle name 1 Guidelines for Magnetic Resonance Safety Evaluation of Medical Devices 2 Guidelines for Registration Review of …
China CMDE Medical Device Registration Review Guidelines Preparation Plan in 2024 Read More »
Recently, China CMDE adjusts the digital certificate management method as follows: Starting from April 15, 2024, the management of CA certificates and other matters will be transferred to the CA certificate issuing agency (Beijing Digital Certification Co., Ltd.). CA certificate applications, information changes, renewals, renewals and re-issuances, etc., shall be handled by the medical device …
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.
On April 10,2024, China CMDE.NMPA released Guidelines for Substantial Equivalence Review —clinical evaluation of absorbable surgical sutures (2024 No.15). Contact us for original documents.
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 …
China CMDE call for public comments on 3 Draf Guidelines Read More »
