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

CMDE, Guidelines, Guiding Principles, Latest News, NMPA, NMPA News, Others / By

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)”

Announcement, CMDE, NMPA, NMPA News, Others / By

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 …

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China NMPA approved 193 medical devices in February 2024

NMPA, NMPA News / By

In February 2024, China NMPA approved a total of 193 registered medical device products. Among them, there are 148 domestic Class III medical device products, 21 imported Class III medical device products, 22 imported Class II medical device products, and 2 Hong Kong, Macao and Taiwan medical device products.

43 Unannounced Inspection was conducted by NMPA Hubei Branch in 2023

NMPA News, Others / By

To strengthen the supervision and regulation of the Medical Device Industry, NMPA Hubei Branch conducted 43 Unannounced Inspection in 2023. Thirty-seven (37) Domestic Manufacturing Facilities and six (6) OEM Manufacturer Facilities outside of Hubei were involved. Two of them were for-cause inspections related to Adverse Events.    There were 268 Inspection Citations recorded, 32 of …

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