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According to the state: 16000 county-level hospitals will usher in great changes!

In recent years, due to the promotion of policies such as hierarchical diagnosis and treatment, county-level medical community, the number of county-level hospitals has been increasing.

more…
NMPA Notice On The Publication Of Guidelines For Quality Management System Audit Of Medical Device Registration

In order to do a good job of quality management system audit under medical device MAH (Market Authorization Holder) system and improve the QMS audit quality for medical device registration, NMPA issued Guidelines for Quality Management System Audit of Medical Device Registration (NMPA, No. 50, 2022) on October 10, 2022. more…
Issued by the department of finance! It is prohibited to purchase imported medical equipment without approval

On September 29, the Ningxia Finance Department issued the Notice on Optimizing the Procurement Management of Imported Products in the Autonomous Region (hereinafter referred to as the Notice).

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The new version of GB9706 series standards is about to be fully implemented. How should medical device enterprises respond?

After the release of the new version of GB9706.1 in 2020, China has successively issued 55 supplementary standards of 9706 series. Most of these standards are implemented on May 1, 2023. Active medical device enterprises should complete the changes and verification of the corresponding medical device products before May 1, 2023, in line with the requirements of the new version of 9706 series standards. more…
A Draft of Guidelines for Product Classification Definition Released

Recently, the Standards Management Center issued a notice on soliciting opinions on the Guiding Principles for the Classification and Definition of Immunohistochemical In Vitro Diagnostic Reagents (Draft for Comments)，The contents are as follows: more…
Just now! The State Health Insurance Administration issued the latest instruction on “Centralized Procurement of Innovative Instruments”

01 .How to purchase innovative medical devices? more…
Main Changes in the New version of the Guidelines for the Verification of the Quality Management System for Medical Device Registration

On October 10, 2022, the NMPA issued a new version of the Guidelines for the Verification of the Quality Management System for the Registration of Medical Devices (Circular No. 50 in 2022) and implemented it from the date of promulgation. The original system verification guidelines (Circular No. 19 in 2020) were repealed more…
Notice on the Guidelines for the Verification of Medical Device Registration Quality Management System Rreleased!

In September 29, 2022, NMPA issued the Guidelines for the Verification of the Quality Management System for the Registration of Medical Devices (No. 19 in 2020). The text of the notice is as follows:

more…
NMPA Notice On The Filing Examination Requirements For Medical Device Registration

On August 31, NMPA released a notice on the issue of Filing Examination Requirements for Medical Device Registration and other Documents (NMPA Notice No. 40 of 2022). According to the notice, the trial requirements issued with NMPA Notice No.42 of 2019 have been revised and the new requirements will be implemented from the date of release. more…
China’s First Domestically Produced Proton Therapy System Gained Approval For Marketing

On Sep 26, 2022, NMPA approved the registration application of the innovative device “Proton Therapy System” produced by Shanghai APACTRON Particle Equipment Co., Ltd. more…
NMPA New Approvals In July 2022

In July 2022, NMPA approved 197 medical devices, including 20 Class III imported products, 22 Class II imported products, and 152 Class III domestic products. more…
NMPA Notice On Matters Related To The Filing Of Class I Medical Devices

In order to do a good job in the filing of Class I medical devices, the NMPA issued a notice concerning the filing of Class I medical devices (including Class I IVD) on August 11, 2022. more…

According to the state: 16000 county-level hospitals will usher in great changes!

In recent years, due to the promotion of policies such as hierarchical diagnosis and treatment, county-level medical community, the number of county-level hospitals has been increasing.

NMPA Notice On The Publication Of Guidelines For Quality Management System Audit Of Medical Device Registration

Issued by the department of finance! It is prohibited to purchase imported medical equipment without approval

On September 29, the Ningxia Finance Department issued the Notice on Optimizing the Procurement Management of Imported Products in the Autonomous Region (hereinafter referred to as the Notice).

The new version of GB9706 series standards is about to be fully implemented. How should medical device enterprises respond?

A Draft of Guidelines for Product Classification Definition Released

Recently, the Standards Management Center issued a notice on soliciting opinions on the Guiding Principles for the Classification and Definition of Immunohistochemical In Vitro Diagnostic Reagents (Draft for Comments)，The contents are as follows: more…

Just now! The State Health Insurance Administration issued the latest instruction on “Centralized Procurement of Innovative Instruments”

01 .How to purchase innovative medical devices? more…

Main Changes in the New version of the Guidelines for the Verification of the Quality Management System for Medical Device Registration

Notice on the Guidelines for the Verification of Medical Device Registration Quality Management System Rreleased!

In September 29, 2022, NMPA issued the Guidelines for the Verification of the Quality Management System for the Registration of Medical Devices (No. 19 in 2020). The text of the notice is as follows:

more…

NMPA Notice On The Filing Examination Requirements For Medical Device Registration

China’s First Domestically Produced Proton Therapy System Gained Approval For Marketing

On Sep 26, 2022, NMPA approved the registration application of the innovative device “Proton Therapy System” produced by Shanghai APACTRON Particle Equipment Co., Ltd. more…

NMPA New Approvals In July 2022

NMPA Notice On Matters Related To The Filing Of Class I Medical Devices