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( Page 26 )
Sales list of Surgical Robots in China in 2021
In 2021, the investment and financing of the domestic surgical robot industry significantly accelerated, and the number of investment and financing increased from 1 in 2013 to 32 in the whole year. The total financing amount of the whole track exceeded 3 billion yuan. The market acceptance is different from that of a decade ago, and the market
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NMPA Collects Public Comments On Adjusting Medical Device Clinical Evaluation Catalog And IVD Clinical Trial Exemption Catalog
On July 5, 2022, the NMPA issued a notice collecting public comments on the catalogues of medical devices exempted from clinical evaluation and IVD exempted from clinical trials.
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What You Must Know About the Commissioned Production of Medical Devices
Article 34 of the
Regulations on the Supervision and Administration of Medical Devices (2021 Edition)
stipulates that medical device registrants and filers may produce medical devices by themselves, or they may entrust enterprises that meet the provisions of these regulations and have corresponding conditions to produce medical devices. This is
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The Latest National Medical Device Product Data in the First Half of 2022: 255,356 Pieces
General situation
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How Is the Unique Identification Going? Start in the Second Half of the Year
According to reports, the landing speed of medical device “ID cards” in the second half of the year will be further accelerated, and by the end of 2022, more varieties will be covered.
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The Medical Insurance Bureau Officially Released: the Management Task of High-value consumables Is Coming
Focus on consumables with a unit price of more than 2000 yuan
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New Regulations, Localization the Only Option for Foreign-Owned Machinery Companies?
Recently, a new State Council document on the
Pilot Project to Enhance the Capacity of High-level Hospitals in Clinical Research and Transformation of Results
has sparked discussions in the industry. The new regulation proposes to adopt the same policies as those supporting
more…
NMPA New Approvals In May 2022
In May 2022, NMPA approved 164 medical devices, including 23 Class III imported products, 30 Class II imported products, and 109 Class III domestic products.
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Post-market Periodic Risk Evaluation Report Mandatory For License Holder In China
As per Measures for the Monitoring and Re-evaluation of Medical Device Adverse Events, NMPA has regulatory requirements for Periodic Risk Evaluation Report (PRER) to enhance post-market surveillance.
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With a Scale of More Than 35Billion, Analysis of China’s Medical Beauty Photoelectricity Device Market
I. Upstream raw materials: biomedical materials, sensors
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Interpretation of the Policy of Beijing Medical Device Administrative Punishment Discretion Benchmark
I. What is the basis and main changes of the revision of
Beijing Medical Device Administrative Punishment Discretion
Benchmark?
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Notice Issued by the State: Key Monitoring of 131 Kinds of Medical Devices
Not long ago, the comprehensive Department of the NMPA released a message. The comprehensive Department of the NMPA publicly solicited
Opinions on Strengthening the Hierarchical Supervision of the Production and Operation of Medical Devices (Exposure Draft).
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