On March 26th, 2024, China CMDE.NMPA released “Guidelines for Registration Review of High-Frequency Surgical Equipment “(2023 Revised Edition). Contact us for the original document.
CMDE is starting the preparation of the ” Guidelines for Registration Review of Metal Bone Marrow Aspiration Needle”, ” Guidelines for Registration Review of Memory Alloy Rib Plating System”, ” Guidelines for Registration Review of Mesh for Skull Repairing”, ” Guidelines for Registration Review of Sternal Strapping/Grasping Fixation System”, “Guidelines for the Registration Review of …
On March 18, 2024, China CMDE.NMPA released four medical device registration review guidelines: 1.“Guidelines for registration review of Corneal topography”, 2.“Guidelines for registration review of Laparoscopic surgery system – Part 2: Animal study necessity analysis and protocol design requirements”, 3.” Guidelines for Registration Review of Laparoscopic Surgical Systems Part 3: Three-Dimensional Endoscopy”, 4.” Guidelines for …
Four Guidelines for Registration Review were released by CMDE.NMPA Read More »
On March 19, 2024, CMDE.NMPA released “Guidelines for Registration Review of Medical Device Usability Engineering”. Log in for original document.
On March 18, 2024, CMDE.NMPA issued the “Guideline for Registration Review of Monkeypox Virus Nucleic Acid Detection Reagents” Log in for original documents.
CMDE is starting the preparation of the “Guideline for Registration and Review of Human T Lymphocytic Leukemia Virus Antibody Detection Reagents” and “Guideline for Registration and Review of Human Leukocyte Antigen (HLA) Gene DNA Typing Detection Reagents”. Companies participating in the preparation work are now being solicited, and domestic and foreign production companies, scientific research …
On January 18, 2024, China CMDE released guidance “Guidelines for Registration Review — Remote Monitoring System” （2024 No.5） Login for original document.
On January 18, 2024, China CMDE released guidance “Guidelines for Registration Review — IVD for Drug of Abuse” （2024 No.4）. Login for original document.
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.
On February 6, 2024, China CMDE.NMPA issued the draft Guidance “Guideline for Registration and Review — Clinical Evaluation of IVD Reagents for Colorectal Cancer Screening” (Draft).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.
