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( Page 24 )
The opportunities of medical devices in China
Contents related to medical and health in the report of the 20th National Congress of the Communist Party of China(CPC):
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Centralized purchase is deepening, and domestic machinery enterprises will usher in a turnaround?
Data shows that more than 90% of hemorrhagic stroke patients use spring coils for treatment, and the traditional Chinese medical instruments for hemorrhagic stroke are the largest submarket in China’s neural intervention market, accounting for 65.5% of the national neural intervention medical instrument market in 2020, with a very broad prospect.
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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.
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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.
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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.
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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:
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Just now! The State Health Insurance Administration issued the latest instruction on “Centralized Procurement of Innovative Instruments”
01 .How to purchase innovative medical devices?
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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
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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:
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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.
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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.
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