Supervision | Real Name Responsibility | Beijing Medical Device Management System

Dec. 6, Beijing Municipal Food and Drug Administration (hereinafter referred to as 'City Food and Drug Administration') issued a "medical device manufacturers in Beijing on behalf of managers (Trial Implementation) "(hereinafter referred to as" Trial Management System ") will come into force on January 1, 2018. The Trial Management System states that medical device manufacturers shall clearly define their representatives and clearly define their responsibilities and authorities At the same time, it requires managers representatives to take charge of the top management of the enterprise and promptly report the defects of the quality management system and the potential safety hazard of the products to the responsible persons of the production enterprises.

Food and Drug Administration medical instruments The relevant person in charge of the registration and supervision department said that the production of medical equipment enterprise During the flight inspection, although some enterprises passed the system verification, they did not meet the standard management in the production practice. The top management tended to pay more attention to the short-term efficiency and efficiency. However, the relevant professional and technical personnel in the enterprise often had no right or power to manage the quality management Decision-making intervention, resulting in internal quality management duties can not be well implemented.At the same time, "medical equipment manufacturing quality management practices" also clear business leaders should determine a manager representative, responsible for the establishment, implementation and maintenance of quality management system, Report the operation of quality management system and improve the demand.

The person in charge said that the "pilot management system" allows companies to truly assume the first responsibility for the safety of medical devices to ensure the quality of medical devices and effectively safeguard the lives of consumers health And mechanical safety.Pilot management system "on behalf of the medical device manufacturers to perform their duties were clearly defined, the implementation of the medical device law, Regulations , Regulations and quality standards, technical requirements; responsible for the establishment and implementation of quality management system, and report to the person in charge of the operation of the quality management system and improve the demand; organization of internal quality management training; organization of product quality Information collection, timely reporting to the person in charge of quality management system defects, as well as product complaints, adverse event monitoring and product safety hazards exist.