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( Page 25 )
Official release: Support for these medical devices from next year (attached list)
The road of localization of foreign-funded machinery enterprises has been continued to be broadened.
more…
Trend analysis of Chinese medical beauty device industry: minimally invasive and non-invasive treatment will promote the popularization of photoelectric medical beauty device
Data show that in 2021, the market size of China’s medical beauty equipment industry is 54.37 billion yuan. It is expected that in 2023, the market size of China’s medical beauty equipment will reach 77.48 billion yuan and is expected to reach 100 billion scale by 2025.
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Blockbuster! Six ministries issued a joint document, concerning all the equipment enterprises!
Six ministries issued a document, concerning all foreign enterprises
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The electronic registration certificate for medical devices implemented from November 1.
The NMPA issued a
Notice
on the
Full Implementation of Electronic Registration Certificate for Medical devices
on January 26. The announcement shows that the scope of issuance of the electronic registration certificate of medical devices is from November 1, including the registration certificate and registration change documents of domestic Class
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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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