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Beijing Market Supervision Administration: Strengthen Supervision of Medical Device Registrars

  Author:MeCan Medical–ultrasound machine manufacturers

The safety of medical equipment is closely related to the health of the people. Recently, the Beijing Market Supervision Administration released the revised "Measures for the Supervision and Management of Medical Device Production Supervision" and the "Measures for the Supervision and Management of Medical Device Management", which will be implemented on May 1, 2022.

Two methods require strict regulatory requirements. Strengthen the supervision and management of medical device registrars, clarify the responsibilities of both registered and entrusted production enterprises, incorporate the relevant requirements of production management into the quality management system, and further improve the inspection responsibilities, inspection methods, results, investigation, investigation, investigation, investigation, investigation, investigation, and investigation. Regulatory requirements such as evidence collection. Improve management requirements for sales, transportation, storage and other aspects of business links, refine the relevant regulations such as traceability management such as purchase inspection and sales records, and strengthen the quality and safety responsibilities of the registered and recorder to sell their registered and filing medical devices.

In terms of implementation of supervision requirements, strengthen the supervision and management of medical device registrars, clarify the responsibilities of both registered and trusted production enterprises, incorporate the relevant requirements of production management into the quality management system, and further improve the inspection responsibilities and inspections of the production link of medical device production. Methods, results disposal, investigation and evidence collection and other supervision requirements. Improve management requirements for sales, transportation, storage and other aspects of business links, refine the relevant regulations such as traceability management such as purchase inspection and sales records, and strengthen the quality and safety responsibilities of the registered and recorder to sell their registered and filing medical devices.

Consolidate the main responsibility of medical device production and operation enterprises. Establish a medical device production report system, stipulates that the production product variety reports, production dynamic reports, changes in production conditions, and the operation of the operation of the quality management system self -examination of the annual report. At the same time, optimize the license filing process, adjust the requirements of business licenses and filing under the medical device registrar system, submit the business license and relevant certification documents when the license is canceled, further compress the verification and approval time limit, and clarify the exemption application information and the application information and It is exempted from the specific circumstances of business filing, and those who apply for permits and filing at the same time simplify procedures such as materials submission.

Compact departmental supervision responsibilities. Refine and improve the responsibilities of regulatory departments at all levels, and improve various supervision and inspection forms such as supervision and inspection, key inspections, tracking inspections, and special inspections. Clarify the duties of the drug regulatory authorities across the provincial commissioned by the registered person, and clarify the joint and assistance regulations of cross -regional supervision and inspection, investigation and evidence collection, etc., and the relevant provisions of the extension inspection and joint inspection of the operation link, and improve the overseas inspection overseas inspection As well as management systems such as information disclosure and responsibility interview.

Strengthen quality and safety risk control. Combined with the actual situation of supervision work, the management and management of medical device production and operation and risk control have been further refined and improving the requirements of inspection. Strengthen the control of quality and safety risks, classify the focus of production and operation supervision and inspection, and to specifically provide clear quality responsibilities and management requirements for medical device registors, recorders and operating enterprises to provide transportation and storage services. At the same time, the pharmaceutical regulatory authorities should carry out regular risk business research and judgment in accordance with the supervision and inspection, product random inspection, adverse event monitoring, complaint reports, and administrative penalties, and do a good job of investigation and prevention and control of hidden dangers of medical equipment.

Beijing Market Supervision Administration: Strengthen Supervision of Medical Device Registrars 1

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