Article 29 engaged in the operation of medical devices, there should be with the scale and scope of business operations and storage conditions, as well as with the operation of medical devices and quality management system and quality management organizations or personnel.
Article 30 is engaged in the second class of medical devices, by the business enterprise to the municipal people's government where the municipal food and drug supervision and management department for the record and submit it to comply with the conditions of Article 29 of these Regulations.
Order 31 engaged in the third class of medical equipment business, the business enterprise shall be located in the municipal people's government food and drug supervision and management department to apply for permission to operate and submit its conditions in line with the provisions of Article 29 of these Regulations.
Acceptance of applications for business license food and drug supervision and management departments shall be accepted within 30 working days from the date of acceptance for review, if necessary, the organization verification. To meet the prescribed conditions, permission is granted and issued to the medical device business license; do not meet the prescribed conditions, not licensed and written reasons.
Medical device license is valid for 5 years. The expiration of the validity of the need for continuation, in accordance with the provisions of the relevant administrative licensing law for continuation procedures.
Article 32 of the medical device business enterprises, the use of units purchasing medical equipment, shall check the qualifications of the supplier and medical equipment qualification documents, the establishment of purchase inspection record system. Engaged in the second, third class medical device wholesale business and third class medical device retail business enterprises, should also establish a sales record system. Record matters include:
(a) the name, model, specifications, quantity of medical devices;
(b) the production batch number of medical devices, expiration date, date of sale;
(c) the name of the manufacturer;
(d) the supplier or purchaser's name, address and contact information;
(e) the relevant permit documents Number, etc.
Incoming inspection records and sales records should be true, and in accordance with the State Council food and drug supervision and management departments to be preserved for the period. The state encourages the use of advanced technical means of recording.
Article 33 of the transportation and storage of medical devices, medical devices should be in accordance with the instructions and labeling requirements; temperature, humidity and other environmental conditions have special requirements, should take appropriate measures to ensure the safety and effectiveness of medical devices.
Article 34 The use of medical devices should be used with the medical device varieties, the number of storage space and conditions appropriate to the use of medical devices.
Medical equipment use units should strengthen the technical training of staff, in accordance with product instructions, technical specifications and other requirements for the use of medical devices.
Article 35 of the medical device use units for reuse of medical devices, shall be in accordance with the provisions of the State Council competent department of health planning and management of disinfection and disposal.
Disposable medical devices shall not be reused, the used shall be destroyed and recorded in accordance with relevant state regulations.
Article 36 The use of medical devices need to be regularly inspected, tested, calibrated, maintenance, maintenance of medical devices, shall be in accordance with the requirements of the product specification for inspection, testing, calibration, maintenance, maintenance and to be recorded in a timely manner to analyze, assess, and to ensure that the medical device is in good condition, to ensure the quality of use; the use of large-scale medical equipment for a long period of time, should be established by the use of files, record its use, maintenance, and record the use, maintenance, and the quality of use. Use of files, records of its use, maintenance, transfer, actual use of time and other matters. Record-keeping period shall not be less than five years after the termination of the specified period of use of medical devices.
Article 37 The use of medical devices should be properly preserved units of the purchase of Class III medical devices of the original information, and to ensure that the information is traceable.
The use of large medical devices and implantable and interventional medical devices, should be the name of the medical device, the key technical parameters and other information, as well as the use of quality and safety closely related to the necessary information recorded in the medical record and other relevant records.
Article 38 found that the use of medical devices there are hidden safety problems, medical devices should be used immediately stop using the unit, and notify the manufacturer or other responsible for the quality of the products of the organization for overhaul; after overhaul still can not meet the use of safety standards of medical devices, shall not continue to use.
Article 39 The food and drug supervision and management departments and the competent departments of health and family planning according to their respective responsibilities, respectively, on the use of medical equipment quality and supervision and management of the use of medical devices.
Article 40 The medical device business enterprises, the use of units shall not be operated, the use of non-registered in accordance with the law, no qualification documents, as well as expired, expired, obsolete medical devices. Article 41 The use of medical equipment between the transfer of medical equipment in use, the transferring party shall ensure that the transfer of medical equipment is safe and effective, shall not transfer the expiration, expiration, elimination, as well as failed inspection of medical equipment.
Article 42 The imported medical devices shall be in accordance with the provisions of Chapter II of these Regulations has been registered or has been filed medical devices.
Imported medical devices should have Chinese instructions, Chinese labeling. Instructions, labels should be consistent with the provisions of these Regulations and the relevant mandatory standards, and in the instructions set out the origin of medical devices and the agent's name, address, contact information. No Chinese instructions, Chinese labels or instructions, labels do not meet the provisions of this article, shall not be imported.
Article 43 of the entry-exit inspection and quarantine agencies in accordance with the implementation of imported medical equipment inspection; failed inspection, shall not be imported.
The State Council food and drug supervision and management department shall promptly notify the national entry-exit inspection and quarantine authorities of the registration and filing of imported medical devices. Import port where the entry-exit inspection and quarantine agencies shall promptly inform the location of the municipal food and drug supervision and management department of the municipal people's government of imported medical equipment clearance.
Article 44 The export of medical devices should ensure that the export of medical devices to meet the requirements of the importing country (region).
Article 45 The advertisements of medical devices shall be true and lawful and shall not contain false, exaggerated or misleading contents.
Medical device advertisements shall be examined and approved by the food and drug administration department of the people's government of the province, autonomous region or municipality directly under the central government where the medical device manufacturer or the agent of the imported medical device is located, and shall obtain the approval documents of the advertisements of medical devices. Advertisers publish medical device advertisements, should be verified in advance advertising approval documents and their authenticity; shall not be published without obtaining the approval of the documents, the authenticity of the approval of the documents has not been verified or the advertisement content is inconsistent with the approval of the documents of the medical device advertisements. Provinces, autonomous regions, municipalities directly under the Central People's Government Food and Drug Administration shall publish and timely update the approved medical device advertising directory and approved advertising content.
The food and drug administration department of the people's government at or above the provincial level shall order the suspension of the production, sale, import and use of medical devices, and shall not publish advertisements involving such medical devices during the suspension period.
Food inspection records, factory inspection records should be true, the preservation period shall not be less than six months after the expiration of the shelf life of the product; there is no clear shelf life, the preservation period shall not be less than two years.
Legal basis：
《中华人民****和国食品安全法》第126条的规定
食品、食品添加剂生产经营者未按规定建立并遵守进货查验记录、出厂检验记录和销售记录制度的，由县级以上人民的规定政府食品药品 Supervision and management department shall order correction, give a warning; refusal to make corrections, impose a fine of five thousand yuan or more than fifty thousand yuan; the circumstances are serious, shall order the suspension of production and shutdown, until the revocation of the license.
"Chinese People's **** and the State Food Safety Law" Article 50, paragraph 2
Food manufacturers shall establish food ingredients, food additives, food-related products purchase inspection record system, truthfully record the name of food ingredients, food additives, food-related products, specifications, quantities, date of production or production batch number, shelf-life, the date of purchase, as well as the name, address, contact information, etc., and the supplier's name, address, contact information, and the content. Address, contact information and other content, and save the relevant vouchers. Records and vouchers to save the period shall not be less than six months after the expiration of the shelf life of the product; there is no clear shelf life, save the period shall not be less than two years.
"Chinese People's **** and the State Food Safety Law" Article 51
Food manufacturers shall establish a food inspection record system, check the factory inspection certificate of food and safety conditions, truthfully record the name of the food, specifications, quantities, date of production or production batch number, shelf life, inspection certificate number, date of sale, and the purchaser's name and address, Contact information and other content, and save the relevant vouchers. Records and vouchers should be kept in line with the provisions of the second paragraph of Article 50 of this Law.
Article 53 of the Food Safety Law of the People's Republic of China
Food business enterprises shall establish a food purchase inspection record system, and truthfully record the name of the food, specifications, quantities, date of production or production batch number, shelf life, date of purchase, as well as the name of the supplier, address, contact information, etc., and save the relevant certificates. Records and vouchers should be saved in accordance with the provisions of Article 50, paragraph 2 of this Law.
Medical device advertising review by the State Council Food and Drug Administration in conjunction with the State Council administrative department for industry and commerce. Business enterprises should also refer to the "Measures for the Administration of Medical Devices" and the local
local documents, the "Regulations" is the guideline, the specific documents are refined.