NMPA News

Summary of medical device technical review in April 2024

CMDE, NMPA, NMPA News / By

The following is the summary of medical device technical review in April 2024: Submissions Overview In Process of Technical Review:1500 Technical Review Completed:1439 Submissions Accepted Document Review:1629 Submissions Accepted:2401 Filing Modification :939 Import Class I Device Filing:262 RFEs and Responses to RFEs RFE released:  659 RFE Response Accepted: 561 Advisory Meetings Meeting initiated:  14 Meeting …

Summary of medical device technical review in April 2024 Read More »

Summary of medical device technical review in February 2024

CMDE, NMPA News / By

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:  …

Summary of medical device technical review in February 2024 Read More »

Information related to medical device registration licenses in China

Latest News, NMPA News / By

As of March 31, 2024，the medical device licensing and filing information in China provinces is as follows: No. Provinces Domestic medical device products Medical Device Manufacturing Medical device Distribution On-Line Sales Filing Third-Party Platform for Medical Device Sales Registration Registration License（pcs） Filing（pcs） Permit（pcs） Filing（pcs） Permit （pcs） Filing（pcs） 1 Beijing 9549 4194 817 710 2832 44041 …

Information related to medical device registration licenses in China Read More »

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 …

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

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 …

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

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 …

43 Unannounced Inspection was conducted by NMPA Hubei Branch in 2023 Read More »

Summary of medical device technical review in January 2024

NMPA News, Technical Review / By

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 …

Summary of medical device technical review in January 2024 Read More »

We Help You Enter China Market

We provide hands-on solutions to you! You are free from the frustration of not knowing China culture. 

Get Appointment