Chapter 1 General Provisions Article 1 In order to regulate the use of drugs and medical devices and protect human health and life safety, in accordance with the "Drug Administration Law of the People's Republic of China" and the "Medical Device Supervision and Administration" of the State Council "Regulations" and other laws and regulations, and based on the actual situation of the province, these measures are formulated. Article 2 These Measures apply to the use of drugs and medical devices by medical institutions, family planning technical service institutions, blood stations, plasmapheresis stations, and rehabilitation assistive device adaptation institutions (hereinafter collectively referred to as user units) within the administrative region of this province, as well as regulatory authorities Supervision and management of its implementation. Article 3 User units shall, in accordance with national regulations, establish a management system for the procurement, receipt, acceptance, storage, care, maintenance, transfer, and use of drugs and medical devices, and assume the safety responsibilities for the use of drugs and medical devices in accordance with the law. Article 4 The food and drug regulatory authorities at or above the county level (hereinafter referred to as the drug regulatory authorities) are responsible for the supervision and management of the use of drugs and medical devices within their respective administrative regions.
The health and family planning, price, industry and commerce, quality supervision and other departments shall be responsible for the supervision and management of the use of drugs and medical devices in accordance with their respective responsibilities. Chapter 2 Procurement, Receipt, and Inspection Article 5 User units shall purchase drugs and medical devices from enterprises with production or business qualifications for drugs and medical devices. Exceptions are made for the purchase of Chinese medicinal materials that are not subject to approval number management and medical devices that are not subject to business license or filing management. Article 6: The user unit shall designate internal institutions or personnel to uniformly purchase drugs and medical devices. Other institutions or personnel are not allowed to purchase on their own. Article 7 When purchasing drugs and medical devices through bidding, the user unit shall strictly implement relevant national and provincial regulations and accept the supervision of the drug regulatory department and other relevant departments. Article 8 When purchasing drugs and medical devices, the user unit shall check and obtain the following information and establish procurement files:
(1) Copies of the drug production or business license and business license, medical device production or business license Copies of business license, registration certificate and business license;
(2) Copy of drug production or business quality management practice certification;
(3) Medical device product registration Copy of the certificate or registration certificate;
(4) Copy of the imported drug registration certificate or pharmaceutical product registration certificate;
(5) Drug inspection report, biological product batch release Copies of certificates of conformity and medical device certificates;
(6) Original copies of authorization letters and identity certificates of drug and medical device sales personnel.
Copies of the materials specified in the preceding paragraph shall be stamped with the seal of the supplier. Article 9 When drugs and medical devices arrive, the user unit shall check and record whether the transportation method meets the requirements, and check whether the drugs and medical devices match the accompanying receipts and invoices.
When medicines and medical devices that need to be refrigerated or frozen arrive, the user should also check and record the transportation time, temperature records during transportation and other quality control conditions. Those that do not meet the temperature requirements shall be rejected. Article 10 When purchasing drugs, user units shall inspect and accept the drugs batch by batch according to the drug batch numbers, and establish true and complete drug acceptance records. Drug acceptance records should indicate the drug’s generic name, manufacturer, dosage form, specifications, production batch number, validity period, approval number, supplier, quantity, arrival date, etc. The drug acceptance record shall be signed by the acceptor. Drugs that fail to pass the acceptance inspection shall be dealt with in accordance with the procurement contract and relevant national regulations.
Using units shall accept and record donated drugs and emergency medicines transferred from other user units in accordance with the provisions of the preceding paragraph. Article 11 When purchasing medical devices, the user unit shall conduct purchase acceptance and establish true and complete medical device acceptance records. The acceptance record shall indicate the product name, specifications, model, quantity, production batch number, validity period, manufacturer, supplier, relevant license or filing certificate number, arrival date, etc.; for sterilized medical devices, sterilization records shall also be recorded date or sterilization batch number. The acceptance record shall be signed by the acceptor. Medical devices that fail to pass the acceptance inspection shall be handled in accordance with the procurement contract and relevant national regulations.
Users of medical devices brought by external doctors or donated medical devices shall be inspected and recorded in accordance with the provisions of the preceding paragraph. Article 12 Drug acceptance records shall be kept for no less than 3 years. If the validity period of the drug exceeds 3 years, the acceptance record shall be kept until 1 year after the expiration of the validity period.
Medical device acceptance records shall be kept until 2 years after the expiration of the specified use period of the medical device or 2 years after the termination of use. The acceptance records of large medical devices shall be kept until 5 years after the expiration of the specified use period of the medical device or 5 years after the termination of use. Implantable medical device acceptance records should be kept permanently. Chapter 3 Storage, Care and Maintenance Article 13 The places, facilities and conditions used by users to store drugs and medical devices shall comply with the storage requirements and relevant national regulations on the packaging labels of drugs and medical devices. The pharmacy of the user unit shall comply with national and provincial pharmacy management regulations. Article 14 User units shall conduct regular inspections of stored drugs and medical devices, and monitor the temperature and humidity of stored drugs and medical devices. Inspections and monitoring situations shall be recorded.
For expired, expired, spoiled, moldy, insect-eaten, damaged or obsolete drugs and expired, damaged, ineffective or obsolete medical devices found during inspection, the user unit shall immediately seal and register them and register them in accordance with relevant regulations. Provide reporting and processing.