CMDE

Preparation and Revisions for 6 Guidelines.

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 …

Preparation and Revisions for 6 Guidelines. Read More »

Preparation of the “Guidelines for Registration and Review of Dengue Virus NS1 Antigen Detection Reagents” and “Guidelines for Registration Review of Helicobacter Pylori Resistance Gene Detection Reagents”.

China CMDE is starting the preparation of the “Guidelines for Registration and Review of Dengue Virus NS1 Antigen Detection Reagents” and “Guidelines for Registration Review of Helicobacter Pylori Resistance Gene Detection Reagents”. Companies participating in the preparation work are now being solicited, and domestic and foreign production companies, scientific research institutions, clinical institutions, etc. with …

Preparation of the “Guidelines for Registration and Review of Dengue Virus NS1 Antigen Detection Reagents” and “Guidelines for Registration Review of Helicobacter Pylori Resistance Gene Detection Reagents”. Read More »

Four Guidelines for Registration Review were released by CMDE.NMPA

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 »

China CMDE.NMPA registration technical review report – Implantable wireless pacemaker

Recently, China CMDE.NMPA published registration technical review report of Implantable wireless pacemaker. Product name: Implantable wireless pacemaker Product category: Class III Applicant name: Abbott Medical Product structure and composition: This product consists of a pulse generator with built-in battery and electrodes and a loading tool. This product is used in conjunction with programmable controllers, delivery …

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Preparation of “Guideline for Registration and Review of Human T Lymphocytic Leukemia Virus Antibody Detection Reagents”

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 …

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Preparation of “Guiding Principles for Registration Review of Human KRAS Mutation Gene Detection Reagents (PCR Method)”

CMDE is starting the preparation of the “Guideline for Registration Review of Human KRAS Mutation Gene Detection Reagents (PCR Method)”, “Guideline for Registration Review of Glucose-6-Phosphate Dehydrogenase Detection Reagents” and “Guideline for Registration Review of Enzyme Detection Reagents Traceability” . Companies participating in the preparation work are now being solicited, and domestic and foreign production …

Preparation of “Guiding Principles for Registration Review of Human KRAS Mutation Gene Detection Reagents (PCR Method)” Read More »