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Laws & Regulations - Medical Devices - Provisions for the Supervision and Administration of Disposable Sterile Medical Devices
Provisions for the Supervision and Administration of Disposable Sterile Medical Devices
 
2012/3/20 14:30:13¡¡Source: ¡¡Hits:

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 regulator

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