Key Benefits:
(Adopted by Order No. 5 of the Government of the Shanghai City on 1 August 2003 at the 14th ordinary meeting of the Shanghai People's Government on 29 July 2003) Article 1 (Legislative purposes) In order to strengthen oversight over a one-time use of unbranted medical devices, prevent medical-source diseases, prevent environmental pollution, guarantee human health and life safety, and develop this provision in conjunction with the provisions of the Medical Assurance Regulation. Article 2 This provision refers to a one-time use of unbranted medical devices (hereinafter referred to as sterilics), which means the registration of products in accordance with sterilics, as well as the marking of “nil” “one-time use” or medical devices that may not be repeated in the product packaging. Article 3 This provision applies to the production, operation, use, destruction and monitoring of stereotyped weapons in this city. Article IV (Management) The Medical Monitoring Authority of the Shanghai City (hereinafter referred to as the Municipal Drug Regulatory Authority) is the competent authority for the production, operation, use and destruction of surveillance management in the city's sterilies. The Regional Drug Regulatory Authority is responsible for the supervision of the production, operation, use and destruction of stereotypes in the current administration. The Shanghai City Health Authority is responsible for the organization, guidance and supervision of the use of steriles and destruction of medical institutions in the city. The relevant administrations, such as environmental protection, business and industry, are in line with their respective responsibilities to oversee the management of unbranted devices. Article 5 The following conditions should also be met, in addition to the conditions set out in article 19 of the Medical Assurance Regulation: (i) Professional technicians and more than two professional test personnel familiar with the production of sterilists; (ii) A net air conditioning system, a clean region and a production environment that is adapted to the production of bacterial devices. In addition to the conditions set out in article 23 of the Medical Assurance Management Regulations, an unbranted business enterprise should also have a place of operation that is adapted to the operation of a sterile, separate from the place of operation and warehouses, and stored in the warehouse with other medical units. Article 6 In accordance with the relevant provisions of the State, a company free of bacteria produced a new construction, alteration, expansion of a clean plant at the location of the plant or from the location of the plant, a first instance, a quality system site review and a product sample test. Article 7 Enterprises with sterilized weapons should organize production in accordance with the State's specialized requirements for the quality of medical equipment, the regulations governing the production of sterilized medical devices and the requirements for the production of regulations, and organize regular internal quality clearances. Article 8 The sterile production enterprise should focus on its clean regions in the production environment, document the parameters of temperatures, humidity, bacteria, etc. in a timely manner, and ensure that the production environment is in line with national requirements for the production environment of sterilists. Article 9 The raw materials, components used in the production of non-bioids by enterprises should be consistent with national standards or relevant requirements. The raw materials, components used in the production of non-bacterial weapons by enterprises that produce stereotypes should be consistent with the raw materials, components identified at the time of registration. Changes in raw materials, components are required in the production process and should be made available to the municipal drug control authorities. The law, legislation and regulations provide otherwise, from their provisions. The raw materials and components of the unbranted manufacturer should be qualified or tested. Article 10 Enterprises with no bacterial weapons production should establish a file No. The Productive Archives include raw materials for products, production and bricks. The product-specific file should be authentic, complete and accurately reflected in the whole process of production. The period of maintenance of the product-specific file should not be less than two years after the expiry of the lifetime of the unbirable. Article 11 (Package) Enterprises with no bacterial weapons should be removed from units consistent with the conditions laid down in the rules of production to packaging materials or small packagings for sterilization and to establish systems for the acquisition, storage, distribution, use and use of product packaging. Amphetamines produced by a sterilized enterprise should be carried out in accordance with a request for use. No duplicated spare parts shall be included in a small packaging. Article 12 In the packaging of unbranted weapons, a reference to “nil”, “one-time use” or non-repetitive symbols should be made in accordance with the designation of a single-time use of a sterile. The labelling of unbranted weapons should be subject to approval of statements of use, indicating the date of production, the production of the ratifiers, the methods of extinguishment and the duration of effectiveness. Article 13 Unbranted products, components, obsolete, invalidated products or dumped products should be destroyed or destroyed in the plant area. Unbranted products, components, obsolete, invalidated products or dumped products and their labels shall not be dumped and dumped as industrial solid wastes after their destruction. Their disposal should be consistent with the relevant provisions of environmental protection. Article 14. The production of steriles, the operation of enterprises should establish a quality tracking system for sterilized weapons, the sale of unbranted weapons products or the record of the purchase should be real and complete, the sale, procurement can trace the quality of each product. The sales records of unbranted enterprises should include the date of sale, the object of sale, the number of sales, the name of the product, the specifications of the manufacture, the bacterial, the period of product effectiveness. The unbranted businesses must control the safety, effectiveness or strictly control the non-benecotics, which should include the date of purchase, the number of purchases, the name of the product, the production of the enterprise, the specifications of the manufacture, the production of bribes, the duration of the product, and the signature of the head and head. The time period for the sale of unbranted weapons products or the acquisition of records and the preservation of valid documents should not be less than two years after the expiry of the product. Article 15 In the event that the manufacturer has found that there are serious flaws in its production, even if the right use is still likely to endanger human health and safety, the immediate suspension of production, cessation of sale, the sale of which has already been sold, urgent measures should be taken to inform the business, medical institutions and users of the suspension or use of the sale or re-recruiting of the products of the group, while reporting to the ICBS. Unbrants produced by a non-semitical manufacturer are in pre-existing conditions, and the industrial drug control authorities may require the production of a business to suspend production, stop sale and take re-entry measures for the sale of the products. The Association of Medical Equipment Industries found that there were serious flaws in the production of unbirable devices by non-sexploitable agents, which could make recommendations to the Municipal Drug Control Agency. Article 16 (Annual nuclear test) In the case of the annual validation of the Medical Acquisition for the Production of Enterprises in accordance with the relevant provisions of the State, the Municipal Drug Regulatory Authority shall conduct nuclear tests in conjunction with the requirement for a specialized system for the quality of the medical equipment for the manufacture of a sterile, the regulations for the production of a bacteriateer and the rules for the production of a production. Article 17 The drug surveillance management conducts daily monitoring of the state of the environment in the clean region of the production of enterprises without bacterial devices, in accordance with national environmental requirements for the production of sterilies. The production environment of a sterilized enterprise is found to be incompatible with national requirements for the production of unbirable devices, and the drug surveillance management should be responsible for changing deadlines; the duration of the enterprise is not rectified or corrected, and the drug control management should be given a notice and recorded in the enterprise regulatory file. The drug surveillance management conducts daily monitoring tests and should comply with the prescribed procedures. A provisional screening of the non-sterilized enterprises should be carried out and the inspection notice should be presented at the site. In carrying out routine monitoring tests, the normal production and operation of unbirable armed manufacturers cannot be affected. Article 18 Medical institutions should be free of sterilization from the law, the procurement of qualified unbranted steriles in the business sector, the purchase of State-mandated sub-categories, and the acquisition of licenses for the production of a medical device for the production of a licence for the production of an enterprise or a licence for the operation of a medical facility, the procurement of qualified steriles in the operation of a business and the registration of a medical certificate of origin, product qualification and other markings. Medical institutions may not be able to purchase stereotypes that do not meet the requirements. Article 19 Medical institutions should be able to maintain steriles in accordance with the requirement for sterilization and store other medical devices. Article 20 Prior to the use of bacterial weapons, medical agencies should check the packaging of unbranted devices in accordance with operational regulations. The use of stereotypeds in cases such as the collapse of small packaging or more effective periods should be stopped. Article 21 The use of files should be established by medical institutions for sterilization. Article 2 (Effective and poisoning after use) In the case of the use of sterilics, medical institutions should require users to destroy the ground; in the absence of a stereotype, they should be centralized within this medical institution; in the absence of a capability to destroy them, and should be stored in specialized containers with warning signs. Medical institutions should dedicate sterilized and undesirable steriles and be stored in specialized containers with warning signs. Article 23. The medical institutions should, in accordance with the relevant provisions of the State and the city, bring to the disposal of the medical waste disposal agencies that are subject to the authority of the law accentuated. Medical institutions should record the transmission of sterilization to destruction. Article 24 Medical institutions shall not have the following acts: (i) Repetitive use of sterilized weapons; (ii) The use of steriles should be destroyed without destruction; (iii) The sale of unbirable devices to others; (iv) The use of stereotyped weapons will be dumped and abandoned; (v) Undestruction and poisoning, the use of sterilized sterilics to be processed outside the medical institution. Article 25 In violation of this provision, there are one of the following acts, which are being corrected by a drug surveillance management order and may be fined up to 1000 dollars in accordance with circumstances: (i) Unbrant-production enterprises do not carry out single packagings according to one-time use, or include, in a small packaging, duplicative parts; (ii) Unbranted products, components, obsolete, invalidated products or abandoned minor packagings and their labels were destroyed or destroyed. In violation of this provision, there are one of the following acts, which are being corrected by the drug surveillance management for the period of time; uncorrected, warnings may be given or fines of up to 5,000 dollars: (i) The unbirable production enterprise does not establish a product-specific file or the falsification of the product-specific file; (ii) Unless prescribed by law, an unbranted enterprise for the production of a sterile or a one-time use of a stereotyped label in its production of a sterile; (iii) The production of non-benecosystems, the record of the unprofessional sale of products or purchases, or the recording of the sale or purchase of products. Unbranted products, components, obsolete, invalidated products or dumped minor packagings and their labels are dumped, abandoned or disposed of environmental protection-related provisions by the environmental administration. Article 26 There are one of the following cases in the medical institutions, which are sanctioned by the drug surveillance authorities in accordance with article 43 of the Medical Assurance Regulation: (i) Repetitive use of sterilized weapons; (ii) The use of steriles should be destroyed. There are one of the following cases in the health-care institutions, which are redirected by the drug supervision management order and may be fined up to 3,000 dollars, depending on the circumstances: (i) The sale of unbirable devices to others; (ii) The use of sterilized and disincentives to be addressed outside this medical institution; (iii) It is not possible to prove that the use of steriles is disposed of by lawful means. There are one of the following cases in the health-care institution, which is being rectified by a drug surveillance management order; a failure to change; a warning may be given or a fine of up to 5,000 dollars: (i) The failure to record the use of steriles to destroy them; (ii) No sterilization, maintenance or storage of unbirable weapons, as prescribed. In violation of the relevant provisions of the protection of the environment, medical institutions are punishable by law by law by the environmental administration authorities by dumping, discarding or unlawfully disposing of steriles. Article 27 This provision was implemented effective 1 October 2003. |
