(Released February 7, 2006, Zibo city people's Government, the 56th as of March 1, 2006) first to strengthen the supervision and administration of medical institutions in medical devices, ensure the medical device is safe and effective, according to the State Department of the supervision and administration of medical devices regulations, combined with the city's actual, these measures are formulated.
II medical devices by the medical institution within the administrative area of the city purchasing, storage and use, supervision and management, application of this approach.
Article referred to in this way refers to the establishment of medical institutions engaged in disease prevention, diagnosis, treatment, health care clinics, family planning technical service institutions and other health and epidemic prevention, health and quarantine, the use of medical devices such as medical research institutions.
Fourth of municipal, district food and drug supervision and management departments in accordance with administrative privileges is responsible for the supervision and administration of medical institutions within the administrative area of medical devices; without food and drug supervision and management departments of the district, its supervision and administration of medical institutions in medical devices by the food and drug supervision and administration departments.
Health, population and family planning, quality and technology supervision departments, shall, within their respective mandates, supervision and administration of medical device-related work in medical institutions.
Article fifth medical institutions shall set up accounts of the medical equipment archives and medical equipment, and strengthen the management of medical devices used to ensure medical device using safe and effective. Sixth use medical device medical institutions shall be filed with the County's food and drug supervision and management departments registration. Registration includes: medical institutions name, address, legal representative, Director, medical device registration category and so on.
The registration content changes, medical institutions shall in the 30th after changes notify the food and drug administration.
Article seventh medical institution shall establish a medical device regulatory agencies or medical device management staff, this unit is responsible for management of medical devices.
Article eighth of used medical equipment in medical institutions shall have the appropriate technical and environmental conditions.
Nineth medical institutions shall establish and implement medical equipment purchase, acceptance, storage, use, maintenance, disinfection, scrap, and other management systems.
Tenth medical organizations of the legal qualification of the suppliers of medical devices should be verified, and saves relevant information. 11th medical institutions buy medical equipment quality check should be carried out. Acceptance includes: product name, size, type, manufacturer, supplier, registration certificates, registration of the medical device table, certification, production date, batch number, sterilization lot number, period of validity, date of purchase, and so on.
Upon acceptance, shall fill in the acceptance record, approval signature and saved for future reference.
Need mandatory product certification or included in the list of national industrial products production permit management of medical devices, inspection should also include compulsory product certification or certificate of production license for industrial products.
12th medical institution again changed hands with medical devices should be tested before use or verify, and does not meet performance requirements for medical devices shall not be used. 13th medical institutions to buy the unit more than 300,000 yuan worth of medical equipment, medical devices should be copies of legal documents reported to the County's food and drug supervision and Management Department.
Food and drug supervision and management departments should be on the legality of medical device products provide advisory service and other related content.
Article 14th store should carry out partition for medical devices, classification, storage, equipped with shelves and the corresponding pad, moisture-proof, pest control, prevention, fire protection, ventilation, light and other facilities. 15th medical institutions using single-use sterile medical devices shall conform to the relevant regulations of the State, establish purchasing, distribution, collection, sterilization, destruction of records.
Equipped with disinfection, destruction of facilities, control waste goes.
Into the medical waste disposal of disposable sterile medical devices, should be directly handled by the medical waste disposal unit. 16th medical institutions using implanted medical devices shall conform to the relevant regulations of the State, set up a special counter storage, establishment of purchase, acceptance, payment records.
Product certificate, registration certificate and copies of medical device registration form should be stored with the records.
17th use of large medical equipment medical equipment should be established in medical institutions use, maintenance record, use and maintenance records should be kept for future reference.
18th medical device quality accident in medical institutions, medical device adverse event shall promptly report to the food and drug administration and medical device adverse reaction monitoring body.
Article 19th has resulted in medical device quality accidents or unsafe medical devices and related information, city and district food and drug supervision and management departments can be sealed up or seized.
20th medical organizations found in the use of dubious quality in medical devices, should be suspended, transferred to the medical device inspection inspection in a timely manner, and to report to the food and drug administration.
21st medical organizations eliminated individual worth more than 300,000 yuan of medical devices, medical devices should be name, size, type, age, reporting districts such as dealing with food and drug administration.
Articles 22nd medical device clinical trials or clinical trials of medical institutions shall comply with the relevant regulations of the State, providing true and complete reporting of clinical trial or clinical trial.
23rd medical institutions shall establish health files of medical device operations. Article 24th food and drug supervision and management departments should strengthen the supervision of medical institutions in medical device inspection and inspection, relevant units and individuals shall not be refused and hid.
Selective testing of medical devices, shall not charge a fee.
25th medical device supervision and inspection, inspection determined to be qualified, a medical institution shall immediately stop using.
Article 26th staff of the food and Drug Administration is aware of the person being checked in the supervision and inspection of technical know-how and business secrets shall be kept confidential.
27th article violates these rules, clear penalties by laws and regulations, from its provisions.
28th article in violation of the regulations, medical institutions are not registered with the food and Drug Administration for record, by the food and Drug Administration ordered to correct them.
29th article violation this approach provides, medical institutions has following behavior one of of, by food drug supervision management sector ordered deadline corrected; late not corrected of, sentenced 1000 Yuan fine: (a) not established medical devices of purchased into, and acceptance, and store, and using, and maintenance, and disinfection, and scrap, and processing, management system of; (ii) no purchased into medical devices quality acceptance records of; (three) one-time using no bacteria medical devices destroyed Hou, cannot master its waste went of.
30th article violates these rules, medical institution again changed hands with medical device, without testing or verification is used, use by the food and Drug Administration to order the suspension, impose a fine of 10000 Yuan.
31st article violates these rules, medical use of implanted medical devices, after certification, the product registration and medical device registration copy stored with the records of the table, by the food and Drug Administration ordered corrected; it fails to, impose a fine of 10000 Yuan.
32nd article violates these rules, medical quality accidents of medical devices or medical device adverse event occurred, did not report adverse drug reaction monitoring in food and drug supervision and management departments and agencies, and impose a fine of 500 Yuan.
33rd article violates these rules, medical authorities refused to provide relevant information, 5000 Yuan fines by the food and Drug Administration to conceal the situation, providing false information, 10000 Yuan fines by the food and drug administration.
34th article violation this approach provides, food drug supervision management sector staff has following behavior one of of, law give administrative sanctions; constitute crime of, law held criminal: (a) found violations not law investigation of; (ii) leaked supervision check in the knows of technology secret and business secret of; (three) bewilders party or received bribery of; (four) other negligence, and abuse, and engages in of behavior.
35th Party considered the violation of their legitimate rights and interests of a specific administrative act of the Executive, may apply for administrative reconsideration or bring an administrative suit.
Article 36th changed hands again in these measures refers to medical devices: used, by medical institutions or medical equipment production and management enterprises once again sales, transfer, gift of medical equipment.
37th article of the rules take effect on March 1, 2006.