Chapter I General Provisions
Article 1 The Provisions are formulated with the view to strengthening the supervision and administration of disposable sterile medical devices and ensuring the safety and effectiveness of products in accordance with the Regulations for the Supervision and Administration of Medical Devices.
Article 2 Disposable sterile medical devices (hereinafter referred to as sterile devices) as defined by the Provisions refer to the medical devices which are aseptic and pyrogen-free and confirmed conforming by testing and are for direct-single use within the term of validity.
Focused supervision and administration shall be exercised over sterile devices, in accordance with the Catalogue of Disposable Sterile Medical Devices (hereinafter referred to as Catalogue).
The Catalogue (see Appendix) is promulgated and adjusted by the State Food and Drug Administration.
Article 3 Any unit or individual engaged in the production, distribution, use, supervision and administration of sterile devices within the boundary of the People’s Republic of China shall observe the Provisions.
Chapter II Supervision and Administration of Production
Article 4 Production of sterile devices shall conform to the Good Manufacturing Practice for Sterile Medical Devices and its Implementation Details, which are promulgated by the State Food and Drug Administration.
Sterile devices shall be tested strictly in accordance with standards; products without testing or unqualified shall not be released.
Article 5 For sterile device production, materials and parts shall be purchased in accordance with the Implementation Details. Enterprises shall keep a complete set of purchase and sale receipts and records for two years after the expiry dates of products.
The purchase and sale records shall include: name of the sale or purchase entity, quantity of sales or purchase, product name, product model and specification, manufacture batch number, sterilization batch number, and term of validity, etc.
Article 6 Manufacturers shall purchase packaging materials or small packages in direct contact with sterile devices from units in conformance with conditions required by the Implementation Details, and shall establish a management system regarding the purchase, storage, dispensation and use of product packaging.
Substandard sterile devices and product packaging or components which are discarded or beyond the expiry dates shall be deformed or destroyed on the spot in the factory and shall not be released from the factory.
Article 7 A manufacturer shall only sell sterile devices produced by itself. The sales staff of the manufacturer shall register at the local drug regulatory department. The following certifications shall be presented when selling sterile devices:
1. copies of the Medical Device Manufacturing Enterprise License and Medical Device Registration Certificate, which bear the stamp of the manufacturer, as well as certificates for qualified products;
2. the original letter of authorization conferred by the legal person of the manufacturer, which bears the stamp of the manufacturer concerned and the seal or signature of the legal person of the manufacturer, defining the scope of the authorization;
3. identification cards of the sales staff.
Article 8 Where there is a change in the name of a manufacturer or in its legal person or responsible person, the manufacturer shall apply to the drug regulatory department at provincial level for the change of Medical Device Manufacturing Enterprise License, and thereafter, apply to the State Food and Drug Administration for the change of Medical Device Registration Certificates. The State Food and Drug Administration and the drug regulatory department at provincial level shall grant the change within 30 working days from the date of accepting the application.
Once the name of a manufacturer is changed, the name on the packages of small, medium and large sizes shall be changed accordingly within half a year. Once a new packaging is used, the old packaging shall be abolished; new packaging and old packaging shall not be used simultaneously.
Article 9 Where a clean room of a manufacturer is newly established, reconstructed or expanded on the original or a different site, it shall be reported to the local drug regulatory department at provincial level for a preliminary inspection of the quality system, and thereafter, reported to the State Food and Drug Administration for an onsite inspection of the quality system and random test of products and, if qualified, production can be started.
Article 10 Where production is interrupted consecutively for longer than one year, the drug regulatory department at provincial level shall conduct an onsite inspection of the quality system and (a) random check(s) of products and, if qualified, production can be resumed; where production is interrupted consecutively for longer than two years, the product registration certificate shall automatically become invalid.
Article 11 Where quality problems occur to observation samples or already distributed sterile device products, the manufacturer shall immediately seal up those products with the same batch number and notify all units concerned to stop selling and using the products. Where a personal injury or death happens, it shall be reported to the local drug regulatory department at provincial level within 24 hours.
Article 12Where a manufacturer is found not in compliance with the requirements in the Implementation Details during surveillance inspection, the drug regulatory department executing the surveillance inspection shall instruct the manufacturer to make corrections within a specified time.
Article 13 A manufacturer shall not have any of the following activities:
1. factory name, address or certificates used are forged or belong to someone else;
2. leasing or lending one’s own valid certifications to others;
3. purchasing components or packaging in violation of regulations;
4. forging or altering purchase and sales invoice and receipt, original record for production and product batch number;
5. failure to dispose of substandard products, discarded components, expired or discarded product packages in accordance with regulations;
6. adding product models and specifications without authorization;
7. selling products not produced by the manufacturer itself;
8. providing sterile devices to town or country fairs or being directly engaged in sterile device trade in town or country fairs.
Chapter III Supervision and Administration of Distribution
Article 14 Distributors shall have business premises and warehouses appropriate for sterile devices to be distributed. Product storage area shall be light-resistant, ventilated and free from pollution, and shall have facilities to protect against dust, pollution, mosquitoes and flies, insects and rodents, and foreign matters, which shall conform to the storage requirements in the product standards.
Article 15 Distributors shall establish a sterile device quality tracking system to ensure that the quality condition of every batch of products can be tracked down from purchase to sales.
The purchase and sales record of sterile devices shall be authentic and complete, including purchase and sales date, purchasing and selling counterparts, quantity, product name, manufacturer, model and specification, production batch number, sterilization batch number, validity term, signatures of the handling person and the person in charge, etc.
Article 16 Distributors shall keep a complete purchase and sales record of sterile devices and valid certifications for two years after the expiry dates of the products.
Article 17 When selling sterile devices, sales staff of distributors shall present the following certifications:
1. copies of the Medical Device Manufacturing Enterprise License and the Medical Device Registration Certificate, which bear the stamp of the distributor concerned, and certificates for qualified products;
2. the original letter of authorization conferred by the legal person of the distributor, which bears the stamp of the distributor concerned and the seal or signature of the legal person of the distributor, defining the scope of the authorization;
3. identification cards of sales staff.
Article 18 Where a distributor finds any substandard sterile device, it shall stop selling the product immediately and report to the local drug regulatory department in time. If the product is confirmed to be substandard, the distributor shall notify all other distributors and the units in time to stop selling or using the sterile devices of the same batch. The substandard products shall be disposed of under the supervision of the local drug regulatory department.
With regard to the substandard sterile devices which have been sold to individuals, the distributors shall announce them to the public and voluntarily recall the substandard products.
Article 19 Where a sterile devices distributor cannot specify the manufacturer of a substandard product, the distributor is deemed as distributing a product without a registration certificate; where a distributor cannot specify the supplier of a substandard product, it is deemed as purchasing products from a supplier without the Medical Device Distributing Enterprise License.
Article 20 A distributor shall not have the following activities:
1. distributing sterile devices without valid certifications, all the required certificates and licenses, or certificates for qualified products;
2. The Medical Device Distributing Enterprise License is forged or belongs to someone else;
3. leasing or lending one’s own Medical Device Distributing Enterprise License to others;
4. distributing sterile devices which are substandard, beyond expiry dates or obsolete;
5. having no purchase and sales records, or forging or altering the purchase and sales records;
6. purchasing sterile devices through illegal channels;
7. providing sterile devices to town or country fairs or being directly engaged in the trade of sterile devices at town or country fairs.
Chapter IV Supervision of Use
Article 21 Medical institutions shall purchase sterile devices from enterprises with the Medical Device Manufacturing Enterprise License or Medical Device Distributing Enterprise License.
Medical institutions shall establish and apply a sterile device purchase and acceptance system and keep a good record. The purchase record shall at least include enterprise name of the purchased product, product name, model and specification, quantity, production batch number, sterilization batch number, validity term, etc. With the record, every batch of sterile devices can be traced to the source of purchase.
1. In purchase of sterile devices from manufacturers, medical institutions shall verify certifications presented by the sales staff of manufacturers and the certifications shall be in line with the provisions in Article 7;
2. In purchase of sterile devices from distributors, medical institutions shall verify certifications presented by the sales staff of distributors and the certifications shall be in line with the provisions in Article 17.
Article 22 Medical institutions shall establish an after-use destruction system for sterile devices. The used sterile devices must be destroyed as required so that the components cannot be reused and shall be turned harmless by sterilization and other measures, and a record shall be kept.
Medical institutions shall not re-use disposable sterile devices.
Article 23 Where a medical institution finds any substandard sterile device, it shall be immediately stopped for use, sealed up and reported to the local drug regulatory departments, and shall not be disposed of without authorization.
Sterile devices which are confirmed to be substandard shall be disposed of under the supervision of the local drug regulatory departments.

Article 24 Where a medical institution using a substandard sterile device cannot specify its manufacturer, the institution is deemed as using a product without a registration certificate; where a medical institution cannot specify the supplier of a substandard product, the institution is deemed as purchasing a product from a supplier without the Medical Device Distributing Enterprise License.
Article 25 Where a serious adverse event occurs with the use of a sterile device in a medical institution, the event shall be reported to the local drug regulatory department at provincial level and the administrative department of health.
Article 26 A medical institution shall not have the following activities:
1. purchasing sterile devices through illegal channels;
2. using sterile devices in damaged small packages or with unclear labels;
3. using sterile devices which are beyond expiry dates and obsolete;
4. using sterile devices without Medical Device Registration Certificate or certificates for qualified products.
Chapter V Surveillance Inspection of Sterile Devices
Article 27 The State Food and Drug Administration shall be responsible for drafting and implementing the national plan for sterile device random inspections. The drug regulatory departments at provincial level shall be responsible for drafting the sterile device random inspection plans for their jurisdictions and implementing the plans after they are submitted to the State Food and Drug Administration for record.
The State Food and Drug Administration and the drug regulatory departments of provinces, autonomous regions and municipalities directly under the Central Government shall publicize the results of the random inspections.
Article 28 A manufacturer, distributor or medical institution which disagrees about the result of a random inspection may, within 15 days from the date of receiving the test report, apply for re-inspection to the drug regulatory departments which have conducted the random inspection or to the drug regulatory department at the next higher level. The drug regulatory department accepting the re-inspection application shall afterwards come to a conclusion about the re-inspection.
Chapter VI Penalties
Article 29 Where sterile devices are produced without Medical Device Registration Certificate, penalties shall be imposed in accordance with Article 35 in the Regulations for the Supervision and Administration of Medical Devices.
Where an enterprise with Sterile Device Registration Certificate, after new construction or reconstruction of factory buildings, starts production without authorization, or forges someone else’s factory name, address or product batch number, or adds models or speculations of sterile devices without authorization, penalties shall be imposed in according with Article 35 of the Regulations for the Supervision and Administration of Medical Devices.
Article 30 Where an enterprise produces sterile devices without Medical Device Manufacturing Enterprise License, forges Medical Device Manufacturing Enterprise License or uses someone else’s Medical Device Manufacturing Enterprise License, penalties shall be imposed in accordance with Article 36 of the Regulations for the Supervision and Administration of Medical Devices.
Article 31 Where an enterprise produces sterile devices that are not conformed to the national or industry standards, penalties shall be imposed in accordance with Article 37 of the Regulations for the Supervision and Administration of Medical Devices.
Article 32 Where an enterprise distributes sterile devices without Medical Device Distributing Enterprise License, penalties shall be imposed in accordance with Article 38 of the Regulations for the Supervision and Administration of Medical Devices.
Article 33 Where an enterprise distributes sterile devices without registration certificates or certificates for qualified products or sterile devices which are beyond the expiry dates, of compromised effectiveness, or obsolete, or purchased through illegal channels, penalties shall be imposed in accordance with Article 39 of the Regulations for the Supervision and Administration of Medical Devices.
Article 34 Where an enterprise submits false certificates, documents, or product samples in registration applications of sterile devices, or uses other deceitful means to obtain sterile device registration certificates, penalties shall be imposed in accordance with Article 40 of the Regulations for the Supervision and Administration of Medical Devices.
Article 35 Where a medical institution uses sterile devices without registration certificates or certificates for qualified products, or sterile devices which are beyond their expiry dates, of compromised effectiveness, or obsolete, or purchased through illegal channels, penalties shall be imposed in accordance with Article 42 of the Regulations for the Supervision and Administration of Medical Devices.
Article 36 Where a medical institution re-uses disposable sterile devices, fails to destroy the sterile devices which should be destroyed, penalties shall be imposed in accordance with Article 43 of the Regulations for the Supervision and Administration of Medical Devices.
Article 37 Where manufacturers, distributors and medical institutions have any of the following activities in violation of the Provisions, the drug regulatory departments at or above county level shall give an instruction for correction with a warning, and impose a fine of no less than 10,000 yuan but no more than 30,000 yuan:
1. producing sterile devices in violation of the provisions in the Implementation Details;
2. forging the original records for products or the purchase and sales invoices and receipts;
3. selling sterile devices produced by other manufacturers;
4. leasing or lending their own valid certificates to others;
5. distributing substandard sterile devices;
6. medical institutions do not have an after-use destruction system for sterile devices, or they forge or alter the purchase record or the after-use destruction record of sterile devices;
7. manufacturers, distributors and medical institutions provide sterile devices to town and country fairs or are directly engaged in the trade of sterile devices at town and country fairs.
Article 38 Where a sterile device manufacturer purchases components and product packaging in violation of regulations or sell substandard sterile devices, the drug regulatory departments at or above county level shall give a warning and an instruction for correction, and impose a fine of no less than 5,000 yuan but no more than 20,000 yuan.
Article 39 Where a sterile device distributor has no purchase and sales records or forges the purchase and sales records, production batch number, sterilization batch number, or validity term, the drug regulatory departments at or above county level shall give a warning, issue an order to stop the distribution and impose a fine of no less than 5,000 yuan but no more than 20,000yuan.
Article 40 Where manufacturers, distributors and medical institutions have any of the following activities in violation of the Provisions, the drug regulatory departments at or above county level shall issue an order for correction with a warning:
1. finding substandard sterile devices but failing to report as required and handling them without authorization;
2. failing to dispose of the discarded components, expired or discarded product packaging in accordance with requirements;
3. distributing or using sterile devices with damaged small packages or unclear labels;
4. failing to report as required in cases of serious adverse events in the use of sterile devices.
Chapter VII Supplementary Provisions
Article 41 The State Food and Drug Administration shall be responsible for the interpretation of the Provisions.
Article 42 The Provisions shall come into force as of the day of promulgation.

Appendix: Catalogue of Disposable Sterile Medical Devices