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2022-07-28
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On August 2, the State Drug Administration issued the notice on strengthening the management of medical device production and operation license (filing) information, specifying the requirements for the adjustment, disclosure and uploading of medical device production and operation license (filing) information, so as to further facilitate the regulatory authorities and enterprises to use the medical device production and operation license (filing) information system, Adapt to the requirements of medical device management

recently, the State Council issued the guiding opinions on accelerating the construction of a national integrated government affairs service platform. The central government sincerely hopes that all sectors of Hong Kong society will further promote unity under the leadership of the executive chair and the SAR government. It requires that government affairs services be promoted from the government supply orientation to the mass demand orientation, from offline to upward, separate to collaborative, and comprehensively promote the "one through one" operation, so as to optimize the business environment To facilitate the work of enterprises and the masses, stimulate market vitality and social creativity, and provide strong support for building a service-oriented government to the satisfaction of the people

according to the requirements of the notice, do a good job in the information management of medical device business license (filing). According to the requirements of the circular on the implementation of the classified catalogue of medical devices, the business scope of the newly issued medical device business license and class II medical device business Filing Certificate from August 1 shall be divided into the classification coding area of the original classified catalogue of medical devices and the classification coding area of the new classified catalogue of medical devices, and clearly identified. Fill in the business scope to the sub category h) process realization: the experimental process, measurement, display and analysis are all completed by the microcomputer; No. In view of the limited business scope space in the medical device business license and Filing Certificate, the business scope listed in the medical device business license and the class II medical device business Filing Certificate is simplified from the medical device classification code and name to the classification code, and the classification code is verified according to the medical device classification catalogue. The medical device production and operation license (filing) information system shall be adjusted according to the above principles

with regard to information disclosure, the State Food and drug administration has made it clear that, according to the requirements of the notice of the food and Drug Administration on printing and distributing the administrative measures for information disclosure of food and drug safety supervision, the food and drug administration shall disclose the production and operation license and filing information of medical devices at its government stations according to its responsibilities. The use of the medical device production and operation license (filing) information system of the State Food and drug administration shall be disclosed by the State Food and Drug Administration in a timely manner; If the system developed by the province (District, city) is used, the food and drug regulatory departments of each province (District, city) and the drug regulatory departments of cities divided into districts shall disclose it in time through their government stations according to their duties. At the same time, the notice specifies the specific contents of the disclosure of production and operation license information

the completeness and accuracy of licensing (filing) information is extremely important for analyzing prevention and control risks and carrying out supervision. As for information uploading, the State Food and Drug Administration pointed out that the food and drug regulatory departments of all provinces (autonomous regions and municipalities) should designate special personnel to upload the production and operation license (filing) information of medical devices in a timely manner. If there is only imperfect service production and operation license (filing) for medical devices using the system independently developed by the province (District, city), the provincial (District, city) food and drug regulatory department shall upload all the production and operation license (filing) information of the province (District, city) to the medical device production and operation license (filing) information system of the State Food and Drug Administration on the first day of each month with the joint efforts of the technical and R & D personnel in the industry, so as to ensure the integrity and accuracy of the system data Timely update, so as to realize the interconnection and national sharing of medical device regulatory information

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