September 13, 2017 at 10:00 am, Director Xu Wei of Xuzhou Food and Drug Administration Medical Device Division convened the city's medical device industry conference at Leo Group, chairman and general manager of more than one hundred medical device companies in Xuzhou City Attend the meeting.

Xu Wei Food and Drug Administration Medical Devices Division Director Su Wei

Director Su Wei delivered a 40-minute speech, mainly in the following aspects:

First, the State Administration of Quality Supervision, Inspection of the clinical application of the registration data to verify the authenticity of the application

Two months ago, the State Administration of Quality Supervision, Inspection 10 companies, there are three problems, including a Xuzhou. Immediately, the State Administration of Industry held an interview with the enterprise and requested the director of the provincial bureau and the director to make an interview and asked the director and director of the city to make interviews. At the same time the corresponding penalties (have applied for registration of returned products, one year may not be registered, suspected of counterfeiting clinical trial base for processing).

In November this year to carry out the second clinical laboratory tests, Ⅱ type of equipment inspection. Enterprises need self-examination as soon as possible, and a good investigation of their own clinical laboratory base, we must ensure that the experiment is true and reliable.

Second, Jiangsu Food and Drug Administration will organize production flight inspection

Time: 9.18 - 10.31 between the year after next year twice a year (spring and autumn each time)

Range: the province's 13 cities

Name: English letters instead of business name

Method: After the inspection team arrived in the cities, the provincial bureau informed the municipalities and enterprises by telephone.

Object: Focus on nearly two to three years in question, but everyone is possible.

Standard: Medical Device Quality Management Practices - Sterile, Implantable, In Vitro Diagnostic Reagents and more

Focus:

1. According to process water guide, "medical device manufacturing enterprise quality management system annual self-examination report compilation guide" and so on

2. "Medical device manufacturers audit guide" (draft)

3 process management, process risk investigation and control of the situation

Third, the State Administration recently issued documents

1. Circular of the General Administration of the People's Republic of China on the Relevant Work Concerning the Implementation of the Quality Management Standards for Medical Device Manufacturing of Class I and Type II Medical Device Manufacturing Enterprises, Food and Drug Administration Supervision [2017] No. 120

2. Notice of the General Administration of China on the Implementation of the "Medical Device Classification" (No. 143 of 2017), 2018.8.1

3 .. "Medical Device Quality Management Practice (Draft)", the provincial bureau, provincial Health Commission will inspect the medical institutions. We want to issue a record of the medical device to receive.

4. Circular of the General Administration of China on Issuing the Guidelines for the Release of Quality Control and Finished Products of Medical Device Manufacturing Enterprises (No. 173 of 2016)

5. Notice of the State Food and Drug Administration on Issuing the Guidelines for Auditing Suppliers of Medical Device Manufacturing Enterprises (No. 1 of 2015) is also the focus of flight inspection.

Xuzhou City Medical Device Industry Association, Lei Austrian Group Chairman Wu Yun speech

At the end of the conference, Wu Yun, Chairman of Xuzhou Medical Device Industry Association and Chairman of Leo Group, delivered a speech on behalf of Xuzhou Medical Device Industry Association.
At the same time, the conference held the 2017 Annual Board Meeting of Medical Device Manufacturers Association of Xuzhou City, conducted the general election for each post of the association, and presided over by Wu Yun, Chairman of Xuzhou Medical Device Industry Association and Chairman of Leo Group.