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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. more…
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. more…
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).

more…
257 Sets of DR and Color Doppler Only Need to Be Made in China!The Winning Bid for a 250 Million Yuan Equipment Order Is Announced

The result of a large equipment purchase order of RMB 252million was announced, and all outstanding domestic equipment such as Mindray, Neusoft, United Imaging and Edan won the bid.

more…

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.

more…

What You Must Know About the Commissioned Production of Medical Devices

The Latest National Medical Device Product Data in the First Half of 2022: 255,356 Pieces

General situation

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.

more…

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

more…

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. more…

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. more…

With a Scale of More Than 35Billion, Analysis of China’s Medical Beauty Photoelectricity Device Market

I. Upstream raw materials: biomedical materials, sensors

more…

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?

more…

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).

more…

257 Sets of DR and Color Doppler Only Need to Be Made in China!The Winning Bid for a 250 Million Yuan Equipment Order Is Announced

The result of a large equipment purchase order of RMB 252million was announced, and all outstanding domestic equipment such as Mindray, Neusoft, United Imaging and Edan won the bid.

more…