Article 29 to engage 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 a license and submit it to meet the conditions of the provisions of Article 29 of these Regulations.
The food and drug supervision and management department accepting applications for business license shall be accepted within 30 working days from the date of review, if necessary, the organization verification. To meet the prescribed conditions, permit and issue a medical device license; do not meet the prescribed conditions, not permit and explain the reasons in writing.
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 and third class medical device wholesale business and the 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, the expiration date, the date of sale;
(c) the name of the production company;
(d) the name, address and contact information for the supplier or purchaser;
(e) the relevant License document number and so on.
Incoming inspection records and sales records should be true, and in accordance with the State Council food and drug supervision and management department of the period to be preserved. The state encourages the use of advanced technical means of recording.
Article 33 of the transportation and storage of medical devices, shall comply with the requirements of medical device instructions and labeling; 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 devices for a long period of time, should be established by the use of files, records of its use, maintenance, and record the use of the device. 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 not registered in accordance with the law, no qualification documents, as well as expired, expired, obsolete medical devices.
Article 41 The transfer of medical equipment between the use of medical equipment, the transferring party shall ensure that the transfer of medical equipment is safe and effective, shall not transfer the expiration date, 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 catalog and the 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.
Methods for reviewing medical device advertisements shall be formulated by the Food and Drug Administration under the State Council in conjunction with the State Council administrative department for industry and commerce.
Operating companies also have to refer to the "Measures for the Administration of Medical Devices" and local documents, the "Regulations" is the guideline, and the specific documents are the refinement.