Anhui Province, the use of drugs and medical devices supervision and management measures

Chapter I General Provisions Article 1 In order to standardize the use of drugs and medical devices, safeguard human health and safety, according to the "People's Republic of China *** and the State Drug Administration Law", "Medical Devices Supervision and Administration Regulations" and "the State Council on the strengthening of food and other product safety supervision and management of the special provisions of the" and other laws and regulations, combined with the actual situation of the province, to formulate the measures. Article 2 These Measures shall apply to the administrative region of the province's medical institutions, family planning technical service institutions (hereinafter collectively referred to as the use of units) of drugs and medical devices, as well as supervision and management activities carried out by the regulatory authorities. Article 3 The use of units in accordance with the relevant practice permit before the use of drugs and medical devices, and bear the responsibility for the safety of drugs and medical devices used in accordance with the law. Article 4 The use of units should be established in accordance with national regulations of drugs and medical devices purchase, acceptance, storage, maintenance, deployment and other management systems. Article V above the county level food and drug supervision and management department (hereinafter referred to as the drug supervision department) is responsible for supervision and management of the use of drugs and medical devices in the administrative region.

Health, population and family planning, industry and commerce, quality supervision, price and other departments in accordance with their respective responsibilities, is responsible for the supervision and management of the use of drugs and medical devices. Chapter II purchase and acceptance of management Article 6 The use of units should be from the production of drugs or medical devices, medical equipment business qualifications of enterprises to purchase drugs or medical devices. Purchase without the implementation of the approval number management of Chinese herbal medicines and medical devices without the implementation of license management except. Article 7 promotes the unified distribution and supply of medicines to rural medical institutions by pharmaceutical enterprises with distribution capacity, and establishes and improves the rural medicine supply network. Article 8 Where drugs and medical devices are purchased by means of centralized bidding and tendering, the user units shall strictly implement the relevant provisions of the state and the province, and accept the supervision of the pharmacological supervision department and other relevant departments. Article IX of the use of units to purchase drugs, medical devices, should check, request the following information, and establish a procurement file:

(a) drugs, medical devices production or business license and a copy of the business license;

(b) a copy of the certificate of quality management standard certification of pharmaceutical production or operation;

(c) imported drugs or pharmaceutical products registration certificate, medical device registration certificate A copy of the registration certificate of imported drugs or pharmaceutical products, medical device registration certificate;

(d) a copy of the drug test report, biological products batch issued certificate of conformity, medical device certificate of conformity;

(e) drugs or single-use sterile medical device sales staff authorization and its identification and sales vouchers.

Copies of the information specified in the preceding paragraph (a) to (d) shall be stamped with the seal of the supplying organization.

The implementation of mandatory safety certification of medical devices, but also in accordance with the "People's Republic of China *** and the State Metrology Law," the provisions of the inspection and request for relevant information. Article X of the use of units purchased drugs, should be according to the drug lot number batch by batch acceptance, check the appearance of drugs, packaging, labeling, instructions, etc., fill out the drug acceptance record. Drug acceptance records should include the generic name of the drug, manufacturer (Chinese herbal medicine marked origin), dosage form, specifications, production batch number, expiration date, approval number, supply unit, quantity, date of purchase, acceptance conclusions, acceptance of the signature and so on. Article XI of the use of units purchased medical devices, should be imported and acceptance, fill out the medical device acceptance record. Medical device acceptance records should include product name, specifications (model), manufacturer, supplier, production lot number (factory number or serial number or date of production), registration number, expiration date, quantity, acceptance conclusions, acceptance of the signature and so on. Sterilization of medical devices should also record the date of sterilization or sterilization lot number.

Using units to invite physicians to bring their own medical equipment, should be checked in accordance with the provisions of the preceding paragraph. Article XII of the drug acceptance record retention time shall not be less than 2 years. The validity of drugs more than 2 years, drug acceptance records are kept until 1 year after the expiration of the expiration date.

Medical device acceptance inspection records should be kept until the expiration of the validity period or stop using 1 year, but not less than 2 years. Implantable medical devices acceptance records should be tracked and saved until the end of the product. Article XIII of the use of units shall not have the following behaviors:

(a) not have the production and operation of qualified enterprises to purchase drugs or medical devices;

(b) unauthorized use or purchase of other health care institutions to formulate preparations or development of medical devices;

(D) from the ultra-operating mode or ultra-operating range of enterprises to purchase drugs or medical devices. Chapter III storage and maintenance management Article XIV of the use of units should be established to regulate the pharmacy, storage of drugs and medical equipment, facilities and conditions should be consistent with the relevant provisions of the State and the instructions for the use of drugs and medical devices. Article XV of the unit of use of stored drugs and medical devices should be regularly inspected, make inspection records. Expired, expired, deteriorated, moldy, insect-infested, broken, out of drugs and expired, broken, out of medical equipment, should be immediately sealed and registered, and reported in accordance with the provisions of the treatment. Article XVI of the use of units should be established in accordance with the provisions of the equipment class medical device files, timely maintenance, school inspection of equipment class medical devices in use, and make a good maintenance, school inspection records.

The maintenance, school inspection can not meet the requirements of product standards for equipment class medical devices, the use of units shall not be used, and in accordance with relevant regulations.