Guidelines for Registration Review — IVD for Drug of Abuse (2024 No.4）
On January 18, 2024, China CMDE released guidance “Guidelines for Registration Review — IVD for Drug of Abuse” （2024 No.4）. Login for original document.
CMDE
“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On January 23, 2024, China CMDE.NMPA issued the draft guidance “Guidelines for Registration Review — Ophthalmic Phacoemulsification and Vitrectomy Equipment and Accessories ” .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 human immunodeficiency virus detection reagents（2024 No.4）
On January 18, 2024, China CMDE released registration guidance “Guidelines for Registration Review – Clinical trials of human immunodeficiency virus detection reagents” (2024 No.4). Log in for original document.
“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On February 5, 2024, China CMDE.NMPA issued the draft guidance “Guidelines for Registration Review — Clinical Trials of Peripheral Drug-Coated Balloon Dilatation Catheters ” CMDE called for the public comments on the draft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.
Announcement on the arrangements for Pre-Submission Communication from March to April 2024 (No. 9, 2024)
CMDE has announced the following schedule for Pre-Submission Communication: Date CMDE Department March 1, 2024 Dept 1/2 of Technical Review Dept 1 of Clinical and Biostatistics March 8, 2024 Dept 3/4 /5 of Technical Review March 15, 2024 Dept 6 of Technical Review Dept 2 of Clinical and Biostatistics General Operation Dept March 22, …
China CMDE.NMPA registration technical review report – Composite Plate System
Recently, China CMDE.NMPA published registration technical review report of composite plate system. Product name: Composite Plate System Product category: Class III Applicant name: CarboFix Orthopedics Ltd. Product structure and composition: This product consists of bone plates and bone screws. The bone plate is made of carbon fiber polyetheretherketone composite material. The material grade is PEEKPEEK-OPTIMA …
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Guideline for registration review of estrogen receptor and progesterone receptor antibody reagents and detection kits (2023 revised version)
On February 7, 2024, China CMDE.NMPA issued the draft guidance “Guideline for registration review of estrogen receptor and progesterone receptor antibody reagents and detection kits (2023 revised version)”. CMDE called for the public comments on the draft guideline before February 29, 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.
CMDE released the Technical Review Guidance for Laser Equipment for Myopia and Amblyopia (2024 No. 6)
On February 5, 2024, CMDE released the Technical Review Guidance for Laser Equipment for Myopia and Amblyopia (2024 No. 6). Login for original document.