NMPA News

Summary of medical device technical review in February 2024

Leave a Comment / CMDE, NMPA News / By Alice

The following is the summary of China CMDE medical device technical review in February 2024: Submissions Overview In Process of Technical Review:1067 Technical Review Completed:1038 Submissions Accepted Document Review:1255 Submissions Accepted:1573 Filing Modification :549 Import Class I Device Filing:107 RFEs and Responses to RFEs RFE released: 497 RFE Response Accepted: 477 Advisory Meetings Meeting initiated: …

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Information related to medical device registration licenses in China

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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Summary of medical device technical review in January 2024

NMPA News, Technical Review / By Alice

The following is the summary of medical device technical review in January 2024: Submissions Overview In Process of Technical Review:1311 Technical Review Completed:1331 Submissions Accepted Document Review:1576 Submissions Accepted:2113 Filing Modification :933 Import Class I Device Filing:187 RFEs and Responses to RFEs RFE released: 643 RFE Response Accepted: 540 Advisory Meetings Meeting initiated: 5 Meeting …

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China NMPA Announcement on the Release of 20 Medical Device Industry Standards including YY 1001-2024 “All Glass Syringe”(No. 16, 2024)

Announcement, NMPA, NMPA News, Standard / By Alice

On February 7, 2024, China NMPA released 20 Medical Device Industry Standards including YY 1001-2024 “All Glass Syringe”. The following is the detail information: No. Standard No. Title Status Scope of application Effective Date 1 YY 1001—2024 All glass syringes Revised This document specifies the structural type, materials, requirements, marking, packaging, transportation and storage of …

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The Accredited laboratories List for GB 9706.1-2020 and YY 9706.102-2021

Announcement, Latest News, NMPA News / By Alice

Till January 8,2024, China National Institutes of Food and Drug Control has issued 1000+ CMA Certificates related to 75 PCS of newly released GB 9706 series and YY 9706 Series Standards. The Accredited laboratories List for GB 9706.1-2020 and YY 9706.102-2021 are released at the same time. This is to help the manufacturers to conform …

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