Zigong Market Supervision Bureau issued 14 measures to promote the high -quality development of the city's medical device industry

In order to thoroughly implement the decision -making and deployment of the municipal party committee and municipal government, help market entities relieve difficulties, and promote the establishment of a new development pattern of the medical device market, the Zigong Market Supervision Bureau issued the "Relevant Measures to Further Promote the Healthy Development of the Medical Device Industry of Zigong City". Through four specific measures in four aspects, they will fully escort the high -quality development of the medical device industry.

1. Further support the orderly development of medical device manufacturers

(1) Optimize inspection and inspection mechanism. For the first filing product, the company passed the product quality management system inspection within the same production address, and the unsupervised random inspection was unqualified, and the credit credit credit was unqualified. The conditions and processes are similar, with the same or similar structural composition, working principle, etc.), which can be removed from on -site verification, and only the authenticity of the sample is performed.

(2) Opinions of the approval of the original production enterprise. A category of medical device enterprises outside the city move in. If the production conditions and product inspection are qualified in Zigong, the original review and approval opinions are admitted to the production qualifications and product filing vouchers.

(3) Support the development model with the industrial park as the main body. Encourage epidemic prevention and control, rehabilitation intelligence and other medical device manufacturers to prepare and put into operation; support the transfer of the medical device industry inside and outside the city, attract research and development platforms, manufacturers and wholesale enterprises to enter the industrial parks, and promote the development of enterprises.

(4) Encourage the establishment of an innovative research and development platform. Fully analyze the characteristics and advantages of medical equipment recorders, effectively build a diversified innovation platform, and use the cooperative relationships established by the Municipal Market Supervision Bureau and Sichuan Province Weikang Institute, Zhejiang University Innovation Center, Vocational and Technical Schools and other units to deepen the multi -party cooperation mechanism of industry, university, research , Promote the effective transformation of the scientific research results of municipal medical institutions, and strengthen the protection of intellectual property rights in medical device.

2. Further optimize the review and approval service of medical device review

(5) Short the approval time limit. The time limit for the newly -run medical device business enterprise has been shortened from 35 working days to 4 working days. The "green channel" of the third -party logistics center settled in the medical device is given priority approval, and the time limit of the license is shortened to 2 working days.

(6) Streamlined license information. If the new type of medical device operation enterprise is applied for the second category of medical device management, the new type of medical device operation enterprises will be exempted from the submission of the second -class filing application information for merger. For the simplified processing process settled in the operating enterprise in the third -party logistics center in the medical device, the third -party logistics center will be submitted to the plane layout map, property right certificate, business facility and equipment directory, computer management system and other qualified materials, and the entry enterprises will no longer provide them separately.

(7) Simplify personnel configuration. For the business enterprise that settled in a third -party logistics center in the medical device, the legal representative or the person in charge of the enterprise will be the person in charge of the quality, but the relevant requirements of the quality leaders in the quality management of medical device business must be met; Personnel such as maintenance, transportation management and other personnel.

(8) Compression processing process. The relevant permits (filing) of the merger and reorganization of medical device business enterprises, such as the business scope, venues, and warehouse addresses, no on -site inspection and acceptance. During the period of corporate merger and reorganization, the business activities can be carried out as usual; if the enterprise applys for the change and continuation of the "Medical Device Business License", it will provide the same address to pass the quality management of medical device operation quality management specifications within one year. (Fight on the date of the inspection), it can be removed on the spot.

3. Further provide the whole process of assistance and guidance

(9) Preliminary intervention guidance. The newly -run first -class manufacturer and second or third -class operating enterprises can submit information on production and operation activities through the WeChat public account of the WeChat public account of the Municipal Market Supervision Bureau (free). In the early stage of "pre -service", the applicant was guided in accordance with the relevant license specifications or standards in terms of system construction, personnel configuration, on -site reconstruction, facilities and equipment installation.

(10) Strengthen training and education. Strengthen the re -education of key positions such as the person in charge of medical device production and operation enterprises, quality managers, and other key positions, increase the training of all employees of the enterprise, organize the study of the current medical device production and operation laws and regulations, etc., to promote their awareness of legal awareness, self -discipline Consciousness, implement quality main responsibility, and improve the concept of quality management.

(11) Implement the "key enterprise stationing system". The Municipal Market Supervision Bureau has selected a group of powerful and potential medical device production and operation enterprises, implemented specialized personnel, implemented "one -to -one" key assistance, and helped enterprises to solve practical problems through on -site guidance and resident assistance, providing enterprises to provide practical problems, provide providing providing practical problems, provide providing practical problems, provide providing practical problems, provide providing practical problems, provide providing practical problems, provide providing practical problems, provide providing practical problems, provide providing practical problems, provide providing practical problems, provide providing practical problems, provide providing practical problems, provide providing practical problems, provide providing practical problems, provide providing practical problems, provide providing practical problems, provide providing practical problems, provide providing practical problems, provide providing practical problems, provide providing practical problems, provide providing practical problems, provide providing practical problems, provide providing practical problems, provide provision The latest policies and regulatory training and other services, improve the quality management system and improve the level of quality management; actively coordinate and connect the functions of the provincial pharmaceutical regulatory bureau, the provincial review center and other functions for the registered production of the second and third categories of medical devices in Zigong. Department, solve related difficulties.

Fourth, effectively ensure the quality and safety of medical equipment

(12) Deepen industry self -discipline. Implement the public commitment system and implement the main responsibility of the enterprise. Establish a credit file system that includes information content such as medical device business license filing, supervision and inspection results, investigation and punishment of illegal behavior, quality spot checks, self -inspection reports, bad behavior records, and complaint reports. For medical device recorders and operating enterprises with bad credit records, increase the frequency of supervision and inspection, jointly punish the enterprise seriously, and create a good market order for integrity and law -based production and operation enterprises. (Thirteenth) Strong supervision and innovation. Actively promote the law enforcement of justice and civilization, adhere to the unification of supervision and tolerance and prudent supervision in accordance with the law, and give the newly established new industries, new models, and new formats for the tolerance period for half a year to one year. Flexible supervision methods, guide and urge enterprises to operate in accordance with the law.

(14) Implement the "four strictests". Effectively utilize supervision resources, combine the annual medical equipment flight inspection work, take risk prevention and control as the principle, make full use of classification and grading management, scientifically determine the frequency of supervision; in -depth special rectification, comprehensively strengthen risk hidden danger investigation and management, severely crack down on fake and counterfeit counterfeit Illegal and illegal acts such as pseudo -inferior medical equipment created a good external environment for industrial innovation and development.

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