Alice

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 Alice

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 Alice

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 Alice

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.

China NMPA approved 321 medical devices in January 2024

NMPA, NMPA News / By Alice

In January 2024, China NMPA approved a total of 321 registered medical device products. Among them, there are 247 domestic Class III medical device products, 41 imported Class III medical device products, and 33 imported Class II medical device products.

43 Unannounced Inspection was conducted by NMPA Hubei Branch in 2023

NMPA News, Others / By Alice

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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Guidelines for Registration Review — Remote Monitoring System （2024 No.5）

CMDE, Guidelines / By Alice

On January 18, 2024, China CMDE released guidance “Guidelines for Registration Review — Remote Monitoring System” （2024 No.5） Login for original document.

Guidelines for Registration Review — IVD for Drug of Abuse (2024 No.4）

CMDE, Guidelines, Technical Review / By Alice

On January 18, 2024, China CMDE released guidance “Guidelines for Registration Review — IVD for Drug of Abuse” （2024 No.4）. Login for original document.

“Guidelines for Registration Review — Ophthalmic Phacoemulsification and Vitrectomy Equipment and Accessories” (Draft)

CMDE, Draft for Comments, Technical Review / By Alice

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）

CMDE, Guidelines, Technical Review / By Alice

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)

CMDE, Draft for Comments / By Alice

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.

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