Shandong Province medical equipment production and management regulations

Article I In order to maintain the order of medical device production and management, improve the quality of medical device products, to protect people's lives and health, according to the relevant provisions of the state, combined with the actual situation in this province, the formulation of these provisions. Article 2 The medical device products referred to in these provisions, refers to the diagnosis of disease, injury or disability, prevention, monitoring, treatment, mitigation, compensation, pregnancy control and physiological function adjustment, human organs instead of instruments, equipment, devices, appliances, implants, materials and related items. Article 3 All units and individuals who produce and operate medical device products within the administrative area of the province must comply with the provisions of this regulation. Article 4 The provincial medical department is responsible for the province's medical device production, management of industry management, and the implementation of supervision and inspection according to law. Provincial medical device product quality inspection agency, according to the provincial technical supervision department authorized, responsible for the province's medical device product quality inspection work.

Industrial and commercial administration, technical supervision and other departments, shall fulfill the responsibilities in the production and operation of medical equipment industry management. Article V production and operation of medical devices, should ensure product quality, strictly prohibit the counterfeiting of medical devices. Article 6 The opening of medical device manufacturing enterprises shall have the following conditions:

(1) with the production capacity of medical devices corresponding to the facilities, technical personnel and health environment, and in line with market demand;

(2) with the level of production of medical devices to match the technical management procedures and quality assurance system;

(3) the state, the province provides other conditions.

Where the conditions listed in the preceding paragraph, shall be reported to the municipal and local medicine department for examination and approval, agreed to be reported to the provincial medicine department for approval. Article VII production of "national industrial products production license directory" listed in the medical device, the implementation of feasibility review system. Without feasibility review, shall not be produced. Article 8 Before organizing the production of new medical device products, the producer shall apply to the competent department of medicine for trial production or quasi-production registration certificate. One or two types of medical devices new product registration certificate to the provincial medical department; three types of medical devices new product registration certificate to the national pharmaceutical authorities. Article IX medical device manufacturers, operators, should strictly abide by national and provincial regulations on product quality, measurement, standardization and management. Article X medical devices into the market before the producer shall apply to the national or provincial pharmaceutical authorities for market access registration certificate. Without the certificate of registration of medical devices, shall not enter the market.

Market access registration number should be marked on the labeling and packaging of medical devices, shall not be forged, transferred or leased. Article XI to open a medical device business, shall have the following conditions:

(a) with the scale of medical device business corresponding to the facilities, quality inspection personnel, sales staff and sanitation environment;

(b) with the ability to operate with the medical device business with the funds;

(c) with the appropriate medical device acceptance of the entry, in the warehouse maintenance and out of the warehouse inspection and issuance system;

(d) with the medical device business with the medical device management system;

(D) national and provincial provisions of other conditions.

Where the conditions listed in the preceding paragraph, shall be declared to the municipal and local medicine department for examination and approval, agreed to be reported to the provincial medicine department for approval. Article XII of the medical device operators shall not commit the following acts:

(a) the operation of substandard quality or the state expressly eliminated medical devices;

(b) the operation of medical devices without market access registration certificate;

(c) the operation of the competent departments of the medicine without the registration and without the commodity inspection department of the imported medical equipment inspection;

(d) National and provincial provisions of other acts. Article XIII of medical device advertising content, shall be examined by the provincial medical department. Application for publication of medical device product advertisements, advertising units should be issued to the relevant written proof of approval. Without written proof, advertising units shall not be produced and broadcast. Article XIV violation of the provisions of one of the following acts, by the provincial or municipal medicine department in charge of a fine of 30,000 yuan, and recommend that the relevant departments of the law to investigate the administrative responsibility of the person in charge of the unit or the person directly responsible for; constitutes a crime, by the judicial organs shall be held criminally responsible.

(a) unauthorized production and operation of medical equipment products;

(b) the operation of the state expressly eliminated medical devices;

(c) the publication and broadcast of medical device advertisements without the provincial competent department of medicine to review the content of the advertisements;

(d) forgery, transfer, rental of medical equipment designated for the production of approval documents and registration certificates. Article XV of laws and regulations on the production and operation of medical equipment violations of penalties and penalties have been clearly stipulated by the authorities, from its provisions. Article XVI of the implementation of fines and penalties must use the financial sector uniformly printed fine receipts. All fines to the state treasury. Article XVII of the administrative penalty decision, may apply for reconsideration or directly to the people's court. Failure to apply for reconsideration, and not prosecuted, and does not fulfill the administrative penalty decision, the authority that made the penalty decision may apply to the people's court according to law for compulsory execution. Article 18 The staff of the competent department of medicine and related departments shall be loyal to their duties, impartiality, and strict law enforcement. Neglect of duty, abuse of power, favoritism and malpractice, by their units or higher authorities to give administrative sanctions; constitutes a crime, by the judicial organs shall be investigated for criminal responsibility. Article 19 The provisions of this May 1, 1997 shall come into force.