Beijing next year, the implementation of medical equipment production management system: enterprises assume the responsibility of the first safety

Recently, the reporter learned from the official website of Beijing Food and Drug Administration that the Beijing Food and Drug Administration issued the "Beijing Medical Device Manufacturer Management Representatives Management System (Trial)", a total of 14 management system Will be implemented on January 1, 2018. The implementation of the new management system will enable enterprises to truly assume the first responsibility for the safety of medical devices, ensure the quality of medical devices and effectively safeguard the lives, health and safety of consumers.
"Beijing medical instruments produce enterprise Management representatives on behalf of the management system (Trial) "Clear medical device manufacturing enterprise manager representative refers to the medical device manufacturers in the corresponding professional background or technical qualifications, and the corresponding work experience, authorized by the manufacturer's head, overall responsibility for quality management System effective operation of the management staff; clear medical device manufacturers managers representatives can perform their duties, one is the implementation of the medical device law, Regulations , Regulations and quality standards, technical requirements, the second is 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 demand, the third is to organize internal quality management training, the fourth is the organization product quality Information collection, promptly report to the person in charge of business quality management system defects, as well as product complaints, adverse event monitoring and product safety hazards exist, the fifth is the product in the presence of a major security risk or a major quality accident, on behalf of Enterprises take the initiative to report to the regulatory authorities in their area and so on.
Beijing Food and Drug Administration medical device registration and supervision of the relevant person in charge told reporters: 'We are in the medical device manufacturing enterprises for flight inspection and found that although some companies have passed the system verification, but in production practices did not reach Standard management, the top managers tend to pay more attention to short-term efficiency and effectiveness, and related professional and technical personnel are often not competent or unable to intervene in quality management decisions, resulting in internal quality management duties can not be well implemented.At the same time, "Medical Instrument Manufacturing Quality Management Code "also clearly responsible business executives should identify a representative of the responsible for the establishment, implementation and maintenance of quality management system to report the operation of the quality management system and improve the demand, etc. Therefore, consider the actual management needs and the upper law We formulated the Management System for Representatives of Medical Device Manufacturers in Beijing (Trial Implementation) to enable enterprises to clarify the responsibilities of their supervisors and to establish and run a quality management system with clear responsibilities and consistent powers and responsibilities so that enterprises can truly assume the responsibility Medical equipment safety first responsibility, ensure medical treatment Equipment quality, and earnestly safeguard the health and safety of consumers' lives.
Beijing Medical Device Manufacturing Enterprise Management Representative Management System
(Trial)
Chapter I General Provisions
Article 1 In order to strengthen the awareness of the main responsibility of Beijing medical device manufacturers (hereinafter referred to as 'manufacturing enterprises') and promote the effective operation of the quality management system of manufacturing enterprises, according to the Regulation on the Supervision and Administration of Medical Devices (Order No. 650 of the State Council of the People's Republic of China ), The Measures for the Administration of the Supervision and Administration of Medical Device Production (Order No. 7 of the State Food and Drug Administration, the Code of Practice for Quality Control of Medical Device Manufacturing (No. 64 of 2014 of the State Food and Drug Administration), etc., The actual city, the development of this system.
Article 2 The manufacturing enterprises and their representatives in the administrative areas of Beijing shall abide by this system in carrying out their quality system management activities.
Article 3 The representative of the manager of a medical device manufacturing enterprise (hereinafter referred to as the manager's representative) means that he has the corresponding professional background or technical qualification and corresponding working experience in the medical device manufacturing enterprise. With the authorization of the person in charge of the manufacturing enterprise, he is fully responsible for the quality management Effective management system administrator.
Article 4 The Beijing Municipal Bureau of Food and Drug Administration (hereinafter referred to as the Municipal Bureau) is responsible for the management of the representatives of the medical device manufacturers in the city. The food and drug administrations (hereinafter referred to as the "district bureaus") of each district, Branch (hereinafter referred to as Direct Branch) is responsible for the management of medical device manufacturers in their respective jurisdictions.
Chapter II The Conditions and Responsibilities of the Manager's Representative
Article 5 A medical device manufacturer shall determine in writing the representative of the manager, clarify his duties and powers, and maintain a scientific, rational and effective operation of the quality management system. The responsible person of the medical device manufacturer shall provide the necessary conditions for the manager's representative to perform his duties, and urge And require the relevant departments within the production enterprise to cooperate with the management representatives to fulfill their duties of quality management and ensure the independent and effective implementation of the functions of the management representatives.
Article 6 Representatives of managers shall observe laws and abide by the law, be honest and trustworthy, and have good professional ethics.An appointment of manager representatives of medical device manufacturing enterprises shall give priority to those who have the following conditions:
(A) there is no serious illegal, illegal record of bad behavior within 3 years;
(B) to obtain medical device management quality system internal auditor or external auditor training certificate of competency, familiar with the quality of medical device manufacturing management, and have the guidance and supervision of manufacturing enterprises in various departments in accordance with the provisions of the implementation of quality management system of professional skills and to solve the problem Ability of problem
(III) Representatives of the third category of medical device manufacturing enterprise managers shall have a bachelor's degree or above in the product-related professional or middle-level technical titles and more than three years of working experience in production, quality and technology management. The second category of medical device manufacturers Management representatives should have the relevant professional college degree or above junior technical titles, and have more than 3 years of production, quality, technical management work experience; the first category of medical device manufacturing enterprise manager representatives should have the relevant professional qualifications, technical titles Or production, quality, technical management work experience.
Article 7 The manager's representative shall be responsible to the top management of the enterprise, and the medical device manufacturer may authorize the manager's representative to perform the following duties in the quality management activities of the manufacturing enterprise:
(A) the implementation of medical equipment laws, regulations, rules and quality standards, technical requirements;
(2) To be responsible for establishing and implementing a quality management system and reporting the operation and improvement of the quality management system to the responsible persons of the manufacturing enterprises;
(3) To organize the training of the quality management of medical devices within the manufacturing enterprises so as to enhance the awareness and ability of employees to comply with relevant laws and regulations and meet the requirements of customers;
(4) Organizing the collection of product quality information, timely reporting the defects of the quality management system to the person in charge of manufacturing enterprises, and the potential safety hazard related to product complaints, adverse event monitoring and products;
(5) When the manufacturing enterprise accepts the supervision and inspection of the food and drug supervision and administration department, it is responsible for coordinating with the food and drug supervision and administration department for supervision and inspection and taking corrective measures according to the opinions of the supervision and inspection;
(6) When the product has a major safety hazard or a major quality accident, it represents the medical equipment manufacturer on its own initiative and reports to the local bureau or subordinate office directly under the state of affairs;
(7) Organizing the preparation of the report on the operation of the quality management system according to the requirements;
(H) other related quality management.
Article 8 If the manager's representative discovers that the quality management system can not operate effectively in accordance with the provisions, or the product quality problems occur, and the serious quality problems are found, he shall promptly report to the person in charge of the manufacturing enterprise, failing to timely take the relevant problems and potential risks Corrective measures should be reported to the food and drug regulatory authorities.
Chapter III appointment and dismissal of managers' representatives and information collection
Article 9 After confirming the selection of manager representatives, the medical device manufacturers shall fill in the Information Collection Form of the Representatives of Beijing Medical Device Manufacturers and their Representatives Education, a copy of the title certificate and resume together with the local bureau, directly under the branch.
The newly-started manufacturing enterprise shall submit relevant materials within 15 working days after obtaining the "Medical Device Production License" or the "First Class Medical Device Production Record Certificate".
The management representative changes, manufacturers should be appointed new manager representative within 10 working days after the submission of relevant materials.
Article 10 The manager's representative can not perform his duties. The manager of the manufacturer should act on behalf of the manager and determine and appoint a new manager's representative within 30 working days.
Article 11 All the bureaus and subordinate branches shall examine the materials submitted by the manufacturing enterprises in accordance with the terms of office of the representatives under the system as set forth in this system and shall at the same time establish the information files of the representatives of the managers and strengthen the performance of their duties by the representatives of the managers of the manufacturing enterprises Checked.
Chapter IV Supplementary Provisions
Article 12 Where a production enterprise fails to appoint a manager representative or an appointed manager representative fails to comply with the provisions, and if the manager representative fails to perform his duties, neglects his duty or dereliction of duty, the manufacturer's district Directly under the relevant requirements of the Bureau, the branch shall be in accordance with the relevant requirements for administrative interviews or administrative cautions manufacturers; if necessary, notified the manufacturing enterprises criticized, or included in medical equipment "blacklist"; suspected of constituting a crime, it should be promptly transferred to the public security department for filing Investigate.
(A) in the medical device quality management system implementation fraud;
(B) of the manufacturing enterprise quality management system there are serious flaws;
(3) The product is not informed of serious quality accidents;
(D) other serious violations of medical equipment regulatory laws and regulations of the situation.
Article XIII of the system by the Beijing food drug Supervisory Authority is responsible for the explanation.
Article XIV of the system since January 1, 2018 implementation.
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