Measures for the supervision and administration of disposable sterile medical devices
(temporary)
Chapter I General Principles
Article 1 In order to strengthen the supervision and management of disposable sterile medical devices and ensure the safety and effectiveness of products, these Measures are formulated in accordance with the Regulations on the Supervision and Administration of Medical Devices.
Article 2 Disposable sterile medical devices as mentioned in these Measures (hereinafter referred to as sterile devices) refer to medical devices that are sterile, pyrogen-free, pass inspection and can be directly used at one time within the validity period.
Sterile devices shall be supervised and managed in accordance with the Catalogue of Sterile Medical Devices for Disposable Use (hereinafter referred to as the Catalogue). The catalogue (see annex) is issued and adjusted by the State Administration of Pharmaceutical Products.
Article 3 All units or individuals engaged in the production, operation, use, supervision and management of sterile instruments within the territory of People's Republic of China (PRC) shall abide by these Measures.
Chapter II Supervision and Administration of Production
Article 4 The production of sterile devices shall be carried out in accordance with the Management Standard for the Production of Sterile Medical Devices and the Detailed Rules for the Implementation of the Production of Sterile Devices promulgated by the State Administration of Medical Devices.
Sterile instruments must be inspected in strict accordance with the standards, and those that have not been inspected or failed to pass the inspection shall not leave the factory.
Article 5 The production of sterile instruments shall purchase materials and spare parts according to the requirements of the Detailed Rules for the Implementation of Production. Enterprises should keep complete purchase and sale documents and records, which should be kept until the product is valid for two years.
The purchase and sale records shall include: the name of the unit selling or purchasing, the quantity supplied or purchased, the product name, model specification, production batch number, sterilization batch number, product expiration date, etc.
Article 6 A production enterprise shall purchase packaging materials or small packages that come into contact with sterile instruments from units that meet the requirements stipulated in the detailed rules for the implementation of production, and establish a management system for the procurement, storage, distribution and use of product packaging. ?
Unqualified sterile instruments and scrapped or expired sterile instrument product packages or components must be destroyed or destroyed in the factory and shall not flow out of the factory.
Seventh production enterprises can only sell sterile instruments produced by their own enterprises. The sales staff of a production enterprise shall register with the pharmaceutical supervisory and administrative department where the sales are located. The following certificates shall be issued when selling:
(a) the medical device manufacturing enterprise license, the medical device product registration certificate and a copy of the product certificate stamped with the enterprise seal;
(two) the original power of attorney of the legal representative of the enterprise stamped with the official seal of the enterprise and the seal or signature of the legal representative of the enterprise, and the power of attorney shall specify the scope of authorization;
(3) the identity card of the salesperson.
Article 8 Where a manufacturing enterprise changes its name, legal representative or person in charge, it shall apply to the provincial drug administration for the change of the License for Medical Device Manufacturing Enterprise and report to the state.
The drug administration has applied for changing the registration certificate of medical device products. The national and provincial drug administrations shall make changes within 30 working days from the date of accepting the application.
After the change of enterprise name, the enterprise name marked on the small, medium and large packages of aseptic devices should be changed within half a year. After the new packaging is put into use, the old packaging shall be stopped, and the new and old packaging shall not be mixed.
Article 9 Where a production enterprise builds, rebuilds or expands a clean workshop at the original site or in a different place, the local provincial drug supervision and administration department will conduct a preliminary examination of its quality system, and the State Medical Device Administration will organize on-site quality system audit and product sampling inspection, and production can only be started after it is qualified.
Article 10 If a production enterprise stops production for more than one year, it must conduct on-site quality system audit, and the provincial drug administration will conduct spot checks on the products, and can resume production only after passing the inspection. If the production is stopped for more than two years, its product registration certificate will automatically become invalid.
Article 11 If there are quality problems in the observed or sold aseptic instrument products, the production enterprise must immediately seal up the batch of products and notify the relevant units to stop selling and using them. Causing personal injury or death, it shall report to the local provincial drug supervision and administration department within 24 hours.
Twelfth supervision and inspection, found that the production enterprises do not meet the requirements of the "detailed rules for the implementation of production", by the implementation of supervision and inspection of the pharmaceutical supervisory and administrative departments shall be ordered to make rectification within a time limit.
Thirteenth production enterprises shall not have the following acts:
(1) Forging or fraudulently using another person's factory name, address or production enterprise certificate;
(2) Renting or lending the valid certificates of the production enterprise;
(3) Purchasing spare parts or product packaging in violation of regulations;
(4) Forging or altering production purchase and sale documents, original production records and product batch numbers;
(five) unqualified products, discarded parts, expired or discarded product packaging is not handled in accordance with the provisions;
(six) unauthorized increase in product models and specifications;
(seven) the sales staff of the enterprise sell products that are not produced by the enterprise;
(eight) to provide sterile equipment to urban and rural markets or directly participate in the transaction of sterile equipment in urban and rural markets.
Chapter III Business Supervision and Management
Article 14 An enterprise shall have a business place and warehouse suitable for its sterile instruments. The product storage area should be dark, ventilated, pollution-free, with dust-proof, pollution-proof, mosquito-proof, insect-proof and foreign body-proof facilities, which meet the storage requirements of product standards.
Fifteenth operating enterprises should establish a quality tracking system for sterile instruments, so that the quality of each batch of products can be traced back from procurement to sales.
The purchase and sale records of sterile instruments must be true and complete. Purchase and sale records shall include: purchase and sale date, purchase and sale target, purchase and sale quantity, product name, production unit, model specification, production batch number, sterilization batch number and product validity period; Signature of the person in charge, etc.
Article 16 An operating enterprise shall keep complete purchase and sale records and valid vouchers of sterile instruments, which must be kept for two years after the product is valid.
Article 17 When selling sterile instruments, the sales staff of a commercial enterprise shall issue the following certificates:
(1) Copies of the Medical Device Business License and the Medical Device Product Registration Certificate stamped with the corporate seal and the product certificate;
(two) the original power of attorney of the legal representative of the enterprise stamped with the official seal of the enterprise and the seal or signature of the legal representative of the enterprise, and the power of attorney shall specify the scope of authorization;
(3) the identity card of the salesperson.
Eighteenth operating enterprises found unqualified sterile equipment, should immediately stop selling, timely report to the local drug supervision and management department. If it is proved to be unqualified, the operating enterprise must promptly notify the operating enterprise and users of the batch of sterile instruments to stop selling or using them. The unqualified products shall be supervised and handled by the local drug supervision and administration department.
For unqualified sterile instruments that have been sold to individuals, the operating enterprise shall announce to the public and take the initiative to take back the unqualified products.
Nineteenth operating enterprises operating unqualified sterile equipment, operators can not specify the manufacturer's unqualified products, as operating products without product registration certificate; If the supplier of unqualified products cannot be determined, it shall be regarded as purchasing products from an enterprise without a Medical Device Business License.
Twentieth operating sterile instruments shall not have the following acts:
(a) operating sterile instruments without valid certificates, certificates and product certificates;
(2) Forging or fraudulently using the Medical Device Business License;
(3) Renting or lending the Medical Device Business License;
(four) unqualified, expired or eliminated sterile instruments;
(five) no purchase and sale records or forged or altered purchase and sale records;
(6) purchasing sterile instruments from illegal channels;
(seven) to provide sterile equipment to urban and rural markets or directly participate in the transaction of sterile equipment in urban and rural markets.
Chapter IV Supervision over Use
Article 21 A medical institution shall purchase sterile instruments from an enterprise with a License for Medical Device Manufacturing Enterprise or a License for Medical Device Trading Enterprise.
Medical institutions should establish a sterile equipment procurement and acceptance system, strictly implement and make records. The procurement record shall at least include the name of the enterprise, product name, model and specification, product quantity, production batch number, sterilization batch number, product validity period, etc. According to the records, the procurement source of each batch of sterile instruments should be traced back.
(1) To purchase sterile instruments from a production enterprise, the certificate issued by the sales staff of the production enterprise shall be fulfilled, and the contents of the certificate issued shall comply with the provisions of Article 7.
(two) the purchase of sterile equipment from a commercial enterprise shall be certified by the sales staff of the commercial enterprise.
According to the provisions of Article 17.
Twenty-second medical institutions should establish a system of destroying sterile instruments after use. Used sterile instruments must be destroyed according to the regulations, so that their parts no longer have the function of use, disinfected and harmless, and recorded.
Medical institutions shall not reuse sterile instruments.
Twenty-third medical institutions found unqualified sterile equipment, should immediately stop using, sealed, and promptly report to the local drug supervision and administration department, shall not be disposed of without authorization.
Sterile instruments that fail to pass the inspection shall be disposed of under the supervision of the local drug supervision and administration department. ?
Twenty-fourth medical institutions use unqualified sterile instruments, and unqualified products that cannot specify manufacturers are regarded as products without product registration certificates; If the supplier of unqualified products cannot be determined, it shall be regarded as purchasing products from an enterprise without a Medical Device Business License.
Twenty-fifth medical institutions in the use of sterile equipment serious adverse events, should be within 24 hours after the incident, to the local provincial drug supervision and management departments and health administrative departments to report.
Twenty-sixth medical institutions shall not have the following acts:
(1) purchasing sterile instruments from illegal channels;
(two) the use of sterile instruments with damaged small packages and unclear labels;
(three) the use of expired and obsolete sterile instruments;
(four) the use of sterile devices without a "medical device product registration certificate" and a medical device product certificate.
Chapter V Supervision and Inspection of Sterile Instruments
Article 27 The State Administration of Medical Devices shall be responsible for compiling the national sampling plan for sterile devices and organizing its implementation. The provincial drug administration is responsible for the preparation of the sampling plan for sterile devices within its jurisdiction, and organizing the implementation after reporting to the State Medical Device Administration for the record.
The State Administration of Pharmaceutical Products and the drug administrations of all provinces, autonomous regions and municipalities directly under the Central Government announced the results of spot checks on sterile devices.
Article 28 If a production and operation enterprise or medical institution disagrees with the results of the spot check, it may, within 5 days from the date of receiving the inspection report, apply to the pharmaceutical supervisory and administrative department that conducted the spot check or its superior pharmaceutical supervisory and administrative department for a re-inspection, and the pharmaceutical supervisory and administrative department that accepted the re-inspection shall make a re-inspection conclusion.
Chapter VI Punishment Rules
Twenty-ninth without obtaining the "medical device product registration certificate" to produce sterile devices, according to the "Regulations on the supervision and administration of medical devices" thirty-fifth punishment.
Enterprises that have obtained the registration certificate of sterile equipment products have built or rebuilt their factories for production without approval; Forging the factory name, address and product batch number of others; Whoever forges or fraudulently uses the registration certificate of medical device products and increases the model and specification of sterile devices without authorization shall be punished according to Article 35 of the Regulations on the Supervision and Administration of Medical Devices.
Article 30 Whoever produces sterile devices without obtaining the License of Medical Device Manufacturing Enterprise, forges or fraudulently uses another person's License of Medical Device Manufacturing Enterprise, shall be punished in accordance with the provisions of Article 36 of the Regulations on the Supervision and Administration of Medical Devices.
Article 31 Whoever produces sterile devices that do not meet the national or industrial standards shall be punished in accordance with the provisions of Article 37 of the Regulations on the Supervision and Administration of Medical Devices.
Thirty-second without obtaining the "medical device business license" to operate sterile devices, according to the "Regulations on the supervision and administration of medical devices" thirty-eighth punishment.
Article 33 Whoever deals in sterile devices without product registration certificate, certificate of conformity, expiration date, invalidation or elimination, or purchases sterile devices from illegal channels, shall be punished in accordance with the provisions of Article 39 of the Regulations on the Supervision and Administration of Medical Devices.
Article 34 Whoever provides false certificates, documents and samples when applying for the registration of sterile devices, or defrauds the registration certificate of sterile devices by other deceptive means, shall be punished in accordance with the provisions of Article 40 of the Regulations on the Supervision and Administration of Medical Devices.
Punishment.
Article 35 Medical institutions that use sterile devices without medical device product registration certificate, certificate of conformity, expiration date, invalidation or elimination, or purchase sterile devices from illegal channels shall be punished in accordance with the provisions of Article 42 of the Regulations on the Supervision and Administration of Medical Devices.
Article 36 Medical institutions that repeatedly use sterile instruments, or should be destroyed but not destroyed, shall be punished in accordance with Article 43 of the Regulations on the Supervision and Administration of Medical Devices.
Article 37 Where an enterprise or medical institution that produces or manages sterile instruments violates the provisions of these Measures and commits any of the following acts, the pharmaceutical supervisory and administrative department at or above the county level shall order it to make corrections, give it a warning and impose a fine of 6,543,800 yuan to 30,000 yuan:
(a) production enterprises in violation of the provisions of the detailed rules for the implementation of production;
(two) the production enterprise forged the original records of products and purchase and sale bills;
(three) the production enterprises sell the sterile instruments of other enterprises;
(4) The production and business operation enterprise rents or lends the valid certificate to others for use;
(five) the operation of unqualified sterile instruments;
(six) the medical institution has not established the system of destruction after use or forged or altered the records of the purchase and destruction of sterile instruments after use;
(seven) production and operation enterprises and medical institutions provide sterile equipment to the urban and rural markets or directly participate in the transaction of sterile equipment in the urban and rural markets.
Article 38 Where a sterile equipment manufacturing enterprise purchases spare parts and product packaging or sells unqualified sterile equipment in violation of regulations, the pharmaceutical supervisory and administrative department at or above the county level shall give it a warning, order it to make corrections and impose a fine ranging from 5,000 yuan to 20,000 yuan.
All right.
Article 39 Where an enterprise dealing in sterile instruments has no purchase and sale records or falsifies purchase and sale records, and falsifies the production batch number, sterilization batch number and product expiration date, the pharmaceutical supervisory and administrative department at or above the county level shall give a warning, order it to stop operating and impose a fine of not less than 5,000 yuan but not more than 20,000 yuan.
Fortieth enterprises and medical institutions that produce and operate sterile instruments violate the provisions of these measures and commit any of the following acts.
The drug supervision and administration department at or above the county level shall order it to make corrections and give a warning:
(a) found unqualified sterile equipment, not according to the provisions of the report, without authorization;
(2) Failing to dispose of discarded spare parts, expired or discarded product packages in accordance with regulations;
(3) Operating or using sterile instruments with damaged small packages and unclear labels;
(four) did not report the occurrence of serious adverse events due to the use of sterile equipment.
Chapter VII Supplementary Provisions
Article 41 The State Administration of Pharmaceutical Products shall be responsible for the interpretation of these Measures.
Article 42 These Measures shall be implemented as of the date of promulgation.