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2021-07-30

Fly inspection bright sword! 11 medical device companies in Jiangsu stopped production for rectification!

Policy Interpretation | "Notice on matters related to the registration of drug-device combination products"

2021-07-30

Fly inspection bright sword! 11 medical device companies in Jiangsu stopped production for rectification!

According to the “Regulations on the Supervision and Administration of Medical Devices” and the “Management Standards for the Quality Management of Medical Devices” and other relevant regulations, the Jiangsu Provincial Drug Administration from May 10 to June 18, 2021 There are many complaints and reports, 34 medical device manufacturers that have not carried out quality system self-inspection or self-inspection of zero defects, and poor quality system operation, etc., have conducted cross unannounced inspections. After inspection and risk consultation, the following 11 companies need to suspend production for rectification (4 of them have ceased production before the cross-flying inspection).

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2021-07-30

Policy Interpretation | "Notice on matters related to the registration of drug-device combination products"

Recently, the State Food and Drug Administration issued the newly revised "Notice on Matters Concerning the Registration of Combination Products of Medicines and Devices" (No. 52 of 2021, hereinafter referred to as Circular No. 52).

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2021-07-27

The 18 most innovative medical devices in 2021

Prix Galien selected the 18 most innovative medical devices in 2021. The selection criteria are as usual. The nominee must be approved by the FDA for marketing within five years and show great potential in improving human health. Another thing worthy of respect for the selection committee is that all nominated products never consider their sales in the market. The selection committee only pays attention to the impact of the product on science and health. This is why Prix Galien is worthy of respect and trust.

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2021-07-27

The Medical Device Professional Committee of CIIE was established at the 100-day countdown to the 4th CIIE

On July 26, the inaugural meeting of the Medical Device Professional Committee of the China International Import Expo Exhibitors Alliance (hereinafter referred to as the Special Committee) was held at the National Convention and Exhibition Center (Shanghai). This event was hosted by the China International Import Expo Bureau and was the fourth One of the 100-day countdown to the opening of the CIIE.

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The Medical Device Professional Committee of CIIE was established at the 100-day countdown to the 4th CIIE

2021-07-26

Press the "fast forward button" to run out of "acceleration" | A review of the top ten work highlights of medical device supervision in the first half of 2021

In the first half of 2021, the newly revised "Regulations on the Supervision and Administration of Medical Devices" (hereinafter referred to as the "Regulations") were formally implemented, the regulatory system for medical device supervision was accelerated, two medical device evaluation and inspection sub-centers started operation, and the medical device industry was innovated and developed The environment continued to be optimized, and 13 innovative medical devices were approved for listing.

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Press the "fast forward button" to run out of "acceleration" | A review of the top ten work highlights of medical device supervision in the first half of 2021

2021-07-22

Announcement of the second batch of national flight inspection ten companies to rectify within a time limit

In order to strengthen the supervision and management of medical devices and ensure the safety and effectiveness of medical devices, in accordance with the "Regulations on the Supervision and Administration of Medical Devices", "Measures for the Supervision and Administration of Medical Device Production"

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Announcement of the second batch of national flight inspection ten companies to rectify within a time limit

2021-07-22

Seminar on comprehensive implementation of medical device registrant system was held in Beijing

On July 20, a seminar on the comprehensive implementation of the medical device registrant system was held in Beijing. As one of the important activities of the National Medical Device Safety Publicity Week in 2021, this meeting analyzed and interpreted the requirements of the newly revised "Regulations on the Supervision and Administration of Medical Devices" (hereinafter referred to as the new "Regulations") on the registration system of medical device registrants, and summarized exchanges. Based on the pilot work experience of my country's medical device registrant system since 2017, it deeply explored the working ideas of the next step to fully implement the medical device registrant system.

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Seminar on comprehensive implementation of medical device registrant system was held in Beijing

2021-07-22

SEMINAR ON FULL IMPLEMENTATION OF MEDICAL DEVICE REGISTRANT SYSTEM HELD IN BEIJING

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2021-07-21

27 provinces have launched a medical device safety promotion week, and special activities are by your side!

On July 19, the 2021 "National Medical Device Safety Publicity Week" was officially launched. In accordance with the unified deployment of the State Food and Drug Administration, all provincial drug regulatory bureaus across the country quickly launched related activities, focusing on the theme of "Innovative Development of Safe Use of Devices". Use your brains and find ways to display the achievements of the party’s century-old medical device through online and offline methods, publicize and implement the "Regulations on the Supervision and Administration of Medical Devices" and its supporting regulations, promote technological innovation and high-quality development of medical devices, and develop medical device knowledge Four aspects of popular science propaganda work hard to promote the publicity week activities to achieve tangible results.

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27 provinces have launched a medical device safety promotion week, and special activities are by your side!

2021-06-22

HAINAN RELEASES WHITE PAPER ON CONSTRUCTION OF FREE TRADE PORT! DRIVEN BY INNOVATIVE MEDICAL DEVICE IMPORT

On June 20, Hainan Free Trade Port issued the White Paper on the Construction of Hainan Free Trade Port (2021) for the first time since its establishment, showcasing the achievements the free trade port has made at its first anniversary in an all-round way, and comprehensively elaborating the main policies and major measures of promoting the construction of the free trade port over the past year.

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HAINAN RELEASES WHITE PAPER ON CONSTRUCTION OF FREE TRADE PORT! DRIVEN BY INNOVATIVE MEDICAL DEVICE IMPORT

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