Aseptic devices according to the "single-use sterile medical device catalog" (hereinafter referred to as "catalog") to implement key supervision and management. Catalog" (see Annex) published by the State Drug Administration and adjusted. Article III Where the Chinese people *** and the State engaged in the production of sterile devices, business, use, supervision and management of the unit or individual shall comply with these measures. Chapter II supervision and management of the production of Article IV production of sterile devices should be carried out by the State Drug Administration promulgated the "production and management of sterile medical devices norms" and sterile devices, "Production Implementation Rules.
Aseptic devices must be strictly in accordance with the standards for testing, uninspected or unqualified shall not leave the factory. Article 5 The production of sterile devices should be in accordance with the requirements of the "Production Implementation Rules" procurement of materials and components. Enterprises shall keep complete purchase and sales bills and records, bills and records shall be kept until two years after the expiration of the validity of the product.
Purchase and sales records shall include: the name of the unit of sale or purchase, supply or purchase quantity, product name, model size, production batch number, sterilization batch number, product expiration date. Article 6 The manufacturer shall purchase packaging materials or small packages from the unit that meets the conditions stipulated in the "Rules for the Implementation of Production" for contact with sterile devices, and shall establish a management system for the purchase, storage, issuance and use of product packaging.
Unqualified sterile devices and waste, expired sterile device product packaging or parts, must be in the factory on-site disfigurement or destruction, shall not be out of the factory. Article 7 The production enterprise can only sell the sterile instruments produced by the enterprise. The sales personnel of the manufacturing enterprise shall be registered with the drug supervision and management department of the place where the sales take place. Sales shall produce the following certificates:
(1) stamped with the seal of the enterprise "medical device manufacturer license", "medical device product registration certificate" copy and product certification;
(2) stamped with the seal of the enterprise and the enterprise's legal representative of the seal or signature of the enterprise's legal representative of the original power of attorney, the power of attorney should be clear authorization range;
(C) the identity card of the salesperson. Article VIII of the manufacturer's business name, legal representative or the person in charge of the enterprise has changed, the enterprise shall apply to the provincial Drug Administration for "medical device manufacturer license" to change the formalities to the State Drug Administration to apply for "medical device product registration certificate" change. State and provincial Drug Administration shall accept the application from the date of 30 working days to give the change.
After the change of enterprise name, the small, medium and large packages of sterile devices labeled with the name of the enterprise should be changed within six months. After the opening of the new package, the old package is to stop using, new and old packaging shall not be mixed. Article IX production enterprises in the original site or off-site new construction, alteration, expansion of clean plants, by the location of the provincial drug supervision and management departments of its quality system for initial review, the State Drug Administration to organize quality system on-site review and product sampling and testing, qualified before production. Article X. Production enterprises to suspend production for more than one year, subject to the provincial Drug Administration on-site quality system review and product sampling and testing, qualified before resuming production, continuous suspension of more than two years, the certificate of registration of its products invalidated. Article XI of sample observation or have been sold sterile device products quality problems, the manufacturer must immediately seal the batch number of products, and notify the relevant units to stop sales and use. Causing personal injury or death, within 24 hours to report the location of the provincial drug supervision and management department. Article XII supervision and inspection, found that the manufacturer does not meet the "Production Implementation Rules" requirements, by the implementation of supervision and inspection of drug supervision and management departments ordered to rectify the deadline. Article XIII of the manufacturer shall not have the following behavior:
(a) forging or fraudulent use of other people's factory name, address or production company documents;
(b) rent or lend the valid documents of the production company;
(c) violation of the provisions of the procurement of parts and components or product packaging;
(d) forgery or alteration of the production of purchase and sale of bills, production of the original records, product batch number;
(E) of substandard products, waste parts and components, expired or discarded product packaging is not handled in accordance with the provisions;
(F) unauthorized increase in product models, specifications;
(VII) the enterprise's sales staff on behalf of the sale of products not produced by the enterprise;
(VIII) to the urban and rural markets to provide aseptic devices or directly involved in the transaction of the urban and rural market for aseptic devices. Chapter III supervision and management of the operation of Article XIV of the business enterprise should have its business with the operation of sterile devices appropriate business premises and warehouses. Product storage area should be protected from light, ventilation, pollution-free, with dust, pollution, mosquitoes and flies, insects and rodents and foreign matter mixing facilities, in line with product standards for storage. Article XV of the operating companies should establish a quality tracking system for sterile devices, from procurement to sales can be traced to the quality of each batch of products.
The purchase and sale of sterile devices must be true and complete records. Purchase and sale records should be: date of purchase and sale, purchase and sale of objects, purchase and sale of quantities, product name, production unit, model specifications, production batch number, sterilization batch number, product expiration date; operator, the person in charge of the signature and so on.