Where laws and regulations provide otherwise, such provisions shall prevail. ?
The units or individuals related to the production, operation, use and supervision and management of medical devices as mentioned in these Measures include:
(1) pharmaceutical machinery manufacturing enterprises and their employees; ?
(2) Medical device wholesale and retail enterprises and their employees; ?
(3) Medical institutions and other users of medical devices and their employees; ?
(four) the food and drug supervision and management departments of the city, county and district (hereinafter referred to as the drug supervision department), the supervision and inspection institutions and their staff. ? Article 3 The municipal drug supervision department shall be responsible for the supervision and administration of the medical device industry in this Municipality.
Industry and commerce, quality and technical supervision, taxation, health, price, labor and social security, family planning, investment promotion and other administrative departments. Should be within the scope of their respective duties, do a good job in the supervision and management of medical devices. ? Article 4 Units and individuals engaged in the production, operation and use of medical devices shall strictly abide by the provisions of national laws, regulations, rules and relevant industry norms.
Units and individuals engaged in the production, operation and use of medical devices shall be responsible for the quality of medical devices produced, operated and used by them. ?
Units and individuals engaged in the production, operation and use of medical devices shall follow the principles of fairness and good faith, be honest and trustworthy, operate in a standardized manner, and conduct business in a civilized manner, and shall not harm the legitimate rights and interests of consumers and the public interests. ? Article 5 Pharmaceutical machinery industry associations shall play the role of supervision, coordination and service, strengthen industry self-discipline, standardize industry behaviors, and safeguard the rights and interests of association members and industry order; Strengthen the popularization and publicity of public health knowledge, and guide consumers to choose medical device products produced, operated and used by legal producers and operators and medical device products with legal labels. ? Article 6 Citizens, legal persons and other organizations are encouraged to conduct social supervision over the practice of medical devices. In violation of these measures, any unit or individual has the right to report to the drug supervision department. ?
The pharmaceutical supervisory and administrative department shall publish its e-mail address or telephone number; The reports received shall be recorded in a timely and complete manner, properly kept and kept confidential for the informants. If the reported matter belongs to the responsibilities of this department, it shall be accepted and verified, handled and answered according to law; If it does not belong to the responsibilities of this department, it shall be transferred to the department that has the right to handle it and inform the informant. ? Article 7 The quality management personnel and drug inspectors of the medical device production, management and use units shall have professional qualifications in pharmacy and other related fields, or have pharmaceutical technical titles, and hold relevant certificates after passing professional training and examination by the municipal drug supervision department. ? Article 8 The drug inspection institutions or personnel of the units producing, trading and using medical devices shall accept the professional guidance of the drug inspection institutions set up by the municipal drug supervision department. ? Article 9 Personnel engaged in acceptance, maintenance, measurement, storage, sales, etc. in the production, operation and use units of medical devices shall have corresponding academic qualifications or a certain degree of education, and hold posts with certificates after professional training and passing the examination by the municipal drug supervision department. For posts with employment access regulations in the country, the staff shall pass the professional skill appraisal and obtain the professional qualification certificate before taking up their posts. ? Article 10 Units that produce, operate and use medical devices shall train their employees in laws, regulations and professional knowledge related to medical devices, and establish training files to record the training time, place, content and training objects. ?
The municipal drug regulatory department shall continue to educate the personnel engaged in the purchase and sale of drugs and medical devices and related work on laws, regulations and professional knowledge every year.
A drug retail enterprise that deals in Class B OTC drugs shall be equipped with qualified business personnel who have passed the examination organized by the municipal drug supervision department. ?
In violation of the provisions of this article, the drug supervision department of the city, county and district shall give a warning and order it to make corrections within a time limit; If no correction is made within the time limit, it shall be ordered to suspend production and business for rectification, and a fine of 2,000 yuan to 20,000 yuan shall be imposed. ? Eleventh medical device production, management and use of units should strengthen the management of medical device practitioners, and make specific provisions on their professional behavior.
Units that produce, manage and use medical devices and their employees shall not commit any of the following acts:
(1) Deliberately misleading consumers to buy drugs in excess of their needs, resulting in drug abuse; ?
(2) deliberately exaggerating the efficacy of medical devices and promoting medical devices for profit;
(3) Giving prescription drugs or over-the-counter drugs and medical devices to the public by tying, buying medical devices as gifts and buying commodities as gifts;
(4) Selling prescription drugs directly to the public by mail or online transactions; ?
(5) Selling prescription drugs without prescription; ?
(6) Selling high-risk implantable medical devices to individuals; ?
(seven) to provide convenient conditions for employees to engage in illegal activities of medical devices in their own units or in their own names. ?
In violation of the provisions of this article, the drug supervision and administration department of the city, county and district shall give a warning to the production, operation and use of medical devices, order them to make corrections, and impose a fine of not less than 3,000 yuan but not more than 30,000 yuan. ?