The Measures for the Supervision and Administration of Disposable Sterile Medical Devices (Provisional), which were deliberated and adopted at the executive meeting of the State Drug Administration on August 17, 2000, are hereby promulgated and shall come into force as of the date of promulgation.
October 13, 2000

Measures for the Supervision and Administration of Sterile Medical Devices for Disposable Use
(Provisional)

 
Chapter I General Provisions
 
Article 1 In order to strengthen the supervision and administration of disposable sterile medical devices and ensure the effectiveness of the products, these Measures are formulated in accordance with the Regulations on the Supervision and Administration of Medical Devices.
 
Article 2 The term "single-use sterile medical devices (hereinafter referred to as sterile devices)" as mentioned in these Measures refers to medical devices that are sterile, pyrogen-free, have passed the inspection and are directly used once within the validity period.
Sterile instruments shall be supervised and managed in accordance with the Catalogue of Sterile Medical Instruments for Disposable Use (hereinafter referred to as the Catalogue). The Catalogue (see annex) shall be promulgated and adjusted by the State Drug Administration.
 
Article 3 All units or individuals engaged in the production, operation, use, supervision and management of sterile instruments within the territory of the People's Republic of China shall abide by these Measures.

Chapter II Supervision and Administration of Production
 
Article 4 The production of sterile instruments shall be carried out in accordance with the "Regulations for the Production and Management of Sterile Medical Instruments" promulgated by the State Drug Administration and the "Detailed Rules for the Implementation of Production of Sterile Instruments".
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 be delivered.
 
Article 5 The materials and components shall be purchased in accordance with the requirements of the Production Implementation Rules for the production of sterile instruments. The enterprise shall keep complete purchase and sales notes and records, and the notes and records shall be kept until the product is valid for two years.
The purchase and sale records shall include: the name of the unit sold or purchased, the quantity of supply or purchase, the name of the product, the model specification, the production batch number, the sterilization batch number, the validity period of the product, etc.
 
Article 6 A production enterprise shall purchase packaging materials or small packages of sterile devices from units that meet the conditions specified in the Detailed Rules for the Implementation of Production, and shall establish a management system for the purchase, storage, distribution and use of product packages. Kill
Unqualified sterile instruments and discarded or expired sterile instrument product packaging or parts must be destroyed or destroyed on site in the factory, and must not be released outside the factory.
 
Article 7 A manufacturing enterprise can only sell the sterile instruments produced by the enterprise. The sales personnel of the production enterprise shall register with the drug supervision and administration department of the place where the sales are located. The following certificates shall be issued at the time of sale:
(I) copies of the Medical Device Manufacturing Enterprise License, the Medical Device Product Registration Certificate and the product qualification certificate stamped with the seal of the company;
(II) the original power of attorney of the legal representative of the enterprise with the seal of the enterprise and the seal or signature of the legal representative of the enterprise, the power of attorney shall specify the scope of authorization;
(III) the salesperson's ID card.
 
Article 8 If the name, legal representative or person in charge of the production enterprise changes, the enterprise shall apply to the provincial drug administration for the change of the medical device production enterprise license, and then apply to the State Drug Administration for the change of the medical device product registration certificate. The national and provincial drug administrations shall make changes within 30 working days from the date of acceptance of the application.
After the name of the enterprise is changed, the name of the enterprise marked on the small, medium and large packages of sterile instruments shall be changed within half a year. After the new packaging is put into use, the old packaging will stop using, and the new and old packaging shall not be mixed.
 
Article 9 Where a production enterprise builds, rebuilds or expands a clean plant at the original site or in a different place, after the local provincial drug supervision and administration department has conducted a preliminary examination of its quality system, the State Drug Administration shall organize an on-site examination of the quality system and product sampling inspection, and can only produce after it is qualified.
 
Article 10 If a production enterprise has continuously stopped production for more than one year, it shall be subject to the examination of the on-site quality system and random inspection of products by the provincial drug administration, and production can be resumed only after it is qualified. If it has continuously stopped production for more than two years, its product registration certificate shall be invalidated by itself.
 
Article 11 If there is a quality problem with the sterile instrument product that has been left for observation or sold, the manufacturer must immediately seal up the batch number of the product and notify the relevant unit to stop the sale and use. If an accident of personal injury or death is caused, it shall be reported to the local provincial drug supervision and administration department within 24 hours.
 
Article 12 In the course of supervision and inspection, if a manufacturing enterprise is found to fail to meet the requirements of the Detailed Rules for the Implementation of Production, the pharmaceutical supervisory and administrative department that implements the supervision and inspection shall order it to make rectification within a time limit.
 
Article 13 A production enterprise shall not commit any of the following acts:
(I) forging or falsely using the name and address of another's factory or the certificate of the production enterprise;
(II) lease or lend the valid certificate of the production enterprise;
(III) purchase parts or product packaging in violation of regulations;
(IV) forging or altering production purchase and sale bills, original production records and product batch numbers;
(V) non-conforming products, discarded parts, expired or discarded product packaging are not handled according to regulations;
(VI) add product models and specifications without authorization;
(VII) the sales staff of the enterprise to sell products not produced by the enterprise on a commission basis;
(VIII) provide sterile instruments to urban and rural bazaars or directly participate in the transaction of sterile instruments in urban and rural bazaars.

Chapter III Supervision and Management of Operations
 
Article 14 An operating enterprise shall have business premises and warehouses suitable for its operation of sterile instruments. The product storage area shall be protected from light, ventilated and pollution-free, with dust-proof, pollution-proof, mosquito and fly-proof, insect and rat-proof and foreign matter-proof facilities, in accordance with the storage regulations of the product standard.
 
Article 15 An operating enterprise shall establish a quality tracking system for sterile instruments, so that the quality of each batch of products can be traced from procurement to sales.
The purchase and sale records of sterile instruments must be true and complete. The purchase and sale records shall include: purchase and sale date, purchase and sale object, purchase and sale quantity, product name, production unit, model specification, production batch number, sterilization batch number, product validity period; signature of the person in charge, etc.
 
Article 16 An operating enterprise shall keep complete records of the purchase and sale of sterile instruments and valid certificates, and the records of the purchase and sale of sterile instruments and valid certificates must be kept until two years after the expiration of the product's validity period.
 
Article 17 Sales personnel of an operating enterprise selling sterile instruments shall issue the following certificates:
(I) copies of the Medical Device Business Enterprise License, the Medical Device Product Registration Certificate and the product qualification certificate stamped with the seal of the company;
(II) the original power of attorney of the legal representative of the enterprise with the seal of the enterprise and the seal or signature of the legal representative of the enterprise, the power of attorney shall specify the scope of its authorization;
(III) the salesperson's ID card.
 
Article 18 If an operating enterprise discovers unqualified sterile instruments, it shall immediately stop selling them and report to the local drug supervision and administration department in a timely manner. If it is verified to be unqualified, the operating enterprise must promptly notify the operating enterprise and user of the batch of sterile instruments to stop selling or using them. The unqualified products shall be dealt with under the supervision of the local drug supervision and administration department.
For unqualified sterile instruments that have been sold for personal use, the operating enterprise shall announce to the public and take the initiative to recover the unqualified products.
 
Article 19 If an operating enterprise operates substandard sterile instruments and the operator fails to specify the producer of the substandard product, it shall be regarded as operating a product without a product registration certificate; if it fails to specify the supplier of the substandard product, it shall be regarded as purchasing the product from an enterprise without the Medical Device Business Enterprise License.
 
Article 20 The following acts shall not be involved in the operation of sterile instruments:
(I) and operate sterile instruments without valid certificates, incomplete licenses and product certificates;
(II) forgery or fraudulent use of the Medical Device Business Enterprise License;
Lease or lend the Medical Device Business License (III);
(IV) the operation of unqualified, expired or eliminated sterile instruments;
(V) there is no record of purchase and sale or forged or altered record of purchase and sale;
(VI) the procurement of sterile instruments from illegal sources;
(VII) provide sterile instruments to urban and rural bazaars or directly participate in the transaction of sterile instruments in urban and rural bazaars.

Chapter IV Supervision of Use
 
Article 21 A medical institution shall purchase sterile instruments from an enterprise with a Medical Device Manufacturing Enterprise License or a Medical Device Operating Enterprise License.
Medical institutions should establish a sterile device procurement, acceptance system, strictly implement and make records. The procurement record shall at least include: the name of the enterprise, product name, model specification, product quantity, production batch number, sterilization batch number, product validity period, etc. The source of the purchase of each batch of sterile instruments shall be traced according to the records.
 
When a (I) purchases sterile instruments from a production enterprise, it shall verify the certificate issued by the sales personnel of the production enterprise, and the content of the certificate shall be in accordance with the provisions of Article 7.
 
When a (II) purchases sterile instruments from an operating enterprise, it shall verify the certificate issued by the sales staff of the operating enterprise.
The content is in accordance with Article 17.
 
Article 22 Medical institutions shall establish a post-use destruction system for sterile instruments. Used sterile instruments must be destroyed in accordance with the provisions, so that their parts do not have the function of use, after disinfection and harmless treatment, and make records.
Medical institutions shall not reuse sterile instruments.
 
Article 23 Medical institutions shall immediately stop using and seal up unqualified sterile instruments, and promptly report to the local drug supervision and administration department, and shall not handle them without authorization.
Sterile instruments that have been verified as unqualified shall be disposed of under the supervision of the local drug supervision and administration department. Kill
 
Article 24 If a medical institution uses substandard sterile instruments and cannot specify the producer of the substandard product, it shall be deemed to use the product without the product registration certificate; if it cannot specify the supplier of the substandard product, it shall be deemed to have purchased the product from an enterprise without the license for the Operation of Medical Devices.
 
Article 25 When a serious adverse event occurs in the use of sterile instruments in a medical institution, it shall, within 24 hours after the occurrence of the event, report to the local provincial drug supervision and administration department and the health administrative department.
 
Article 26 A medical institution shall not commit any of the following acts:
(I) purchase of sterile instruments from illegal sources;
(II) the use of sterile instruments with small packages that have been damaged and poorly marked;
(III) the use of expired, obsolete sterile instruments;
(IV) use sterile instruments without Medical Device Product Registration Certificate or Medical Device Product Certificate.

Chapter V Supervision and Inspection of Sterile Instruments
 
Article 27 The SDA shall be responsible for the preparation of a national plan for the random inspection of sterile instruments and organize its implementation. The provincial drug administration shall be responsible for the preparation of a plan for the random inspection of sterile instruments under its jurisdiction, which shall be submitted to the State Drug Administration for the record and then organized for implementation.
The SDA and the drug administrations of all provinces, autonomous regions and municipalities directly under the Central Government shall publish the results of spot checks on sterile instruments.
  
Article 28 If the production and trading enterprises and medical institutions have objections to the results of the random inspection, they may, within 15 days from the date of receipt of the inspection report, apply to the drug supervision and administration department that carried out the random inspection or the drug supervision and administration department at the next higher level for re-inspection, and the drug supervision and administration department that accepts the re-inspection shall make the re-inspection conclusion.

Chapter VI Penalties
 
Article 29 The production of sterile devices without obtaining the "Medical Device Product Registration Certificate" shall be punished in accordance with Article 35 of the "Regulations on the Supervision and Administration of Medical Devices.
Enterprises that have obtained the "Sterile Device Product Registration Certificate" build or rebuild factories without approval to produce without approval; forge the name, address, and product batch number of others; forge or falsely use the "Medical Device Product Registration Certificate" without authorization Those who increase the model and specifications of sterile devices shall be punished in accordance with Article 35 of the Regulations on the Supervision and Administration of Medical Devices.
 
Article 30 Those who produce sterile devices without obtaining the "Medical Device Manufacturing Enterprise License" and forge or fraudulently use the "Medical Device Manufacturing Enterprise License" of others shall be punished in accordance with Article 36 of the "Regulations on the Supervision and Administration of Medical Devices.
 
Article 31 The production of sterile devices that do not meet the national standards or industry standards shall be punished in accordance with Article 37 of the Regulations on the Supervision and Administration of Medical Devices.
 
Article 32 Anyone who operates sterile instruments without the "Medical Device Business Enterprise License" shall be punished in accordance with Article 38 of the "Regulations on the Supervision and Administration of Medical Devices.
 
Article 33 Those who operate sterile instruments without product registration certificate, qualified certificate, expired, invalid or eliminated, or purchase sterile instruments from illegal channels, shall be punished in accordance with Article 39 of the Regulations on the Supervision and Administration of Medical Devices.
 
Article 34 When applying for the registration of sterile devices, providing false certificates, documents, samples, or adopting other deceptive means to defraud the registration certificate of sterile device products, according to Article 40 of the Regulations on the Supervision and Administration of Medical Devices
Penalty.
 
Article 35 If a medical institution uses a sterile instrument without a "Medical Device Product Registration Certificate", a certificate of conformity, expiration, invalidation, or elimination, or purchases a sterile instrument from an illegal channel, it shall be punished in accordance with Article 42 of the Regulations on the Supervision and Administration of Medical Devices.
 
Article 36 If a medical institution repeatedly uses sterile instruments, or fails to destroy them, it shall be punished according to Article 43 of the Regulations on the Supervision and Administration of Medical Devices.
 
Article 37 If an enterprise or medical institution producing or operating 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 a warning, and impose a fine of not less than 10000 yuan and not more than 30000 yuan:
(I) production enterprises produce in violation of the provisions of the Detailed Rules for the Implementation of Production;
The (II) production enterprise falsifies the original records of the product and the purchase and sale bills;
(III) manufacturing enterprises sell sterile instruments of other enterprises;
A (IV) production or business enterprise rents or lends a valid certificate to others for use;
(V) the operation of substandard sterile instruments;
The (VI) medical institution fails to establish a post-use destruction system or falsifies or alters the records of purchasing and post-use destruction of sterile instruments;
(VII) production and operation enterprises and medical institutions provide sterile instruments to urban and rural markets or directly participate in the transaction of sterile instruments in urban and rural markets.
 
Article 38 If an enterprise producing sterile instruments purchases spare parts and product packaging or sells substandard sterile instruments in violation of regulations, the drug regulatory department at or above the county level shall give a warning, order it to make corrections, and impose a 20000 of not less than 5000 yuan.
Fines.
 
Article 39 If an enterprise dealing in sterile instruments has no purchase and sale records or forges purchase and sale records, forges production batch number, sterilization batch number and product validity period, the drug regulatory department at or above the county level shall give a warning, order it to stop the operation, and impose a fine of not less than 5000 yuan but not more than 20000 yuan.
 
Article 40 Enterprises and medical institutions producing and operating sterile instruments violate the provisions of these Measures and commit one of the following acts
The drug supervision and administration department at or above the county level shall order the correction and give a warning:
(I) found unqualified sterile instruments, not in accordance with the provisions of the report, without authorization to deal;
The (II) does not dispose of the discarded parts or expired or discarded product packages in accordance with the regulations;
(III) dealing in or using sterile instruments whose small packages have been damaged and the marks are not clear;
Failure to report serious adverse events when (IV) use of sterile instruments.

Chapter VII Supplementary Provisions
 
Article 41 These Measures shall be interpreted by the SDA.
 
Article 42 These Measures shall be implemented as of the date of promulgation.