Article I In order to strengthen the supervision and management of single-use sterile medical devices, to ensure product safety, effective, according to "supervision and management of medical devices regulations" to develop these measures.
Second Article The single-use sterile medical devices referred to in these measures (hereinafter referred to as sterile devices) refers to sterile, pyrogen-free, qualified by the test, in the validity period of one-time direct use of medical devices.
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 3 Where the Chinese people *** and the State engaged in the production of sterile devices, business, use, supervision and management of units or individuals shall comply with these measures. Article IV production of sterile devices should be implemented in the State Drug Administration promulgated the "production of sterile medical devices management norms" and sterile devices "production implementation rules".
Aseptic devices must be strictly in accordance with the standards for inspection, without inspection or unqualified inspection 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 the expiration of the product validity period of two years.
Purchase and sales records should include: the name of the unit of sale or purchase, supply or purchase quantity, product name, model specifications, production batch number, sterilization batch number, product expiration date.
Article VI The manufacturer shall purchase the packaging materials or small packages that contact the sterile instruments from the unit that conforms to the conditions stipulated in the "Production and Implementation Rules", and shall establish a management system for the purchase, storage, issuance and use of the product packaging.
Unqualified sterile instruments and waste, expired sterile instrument product packaging or parts, must be in the factory on-site disfigurement or destruction, shall not be out of the factory.
Article VII The production enterprise can only sell the sterile instruments produced by the enterprise. The sales staff of the manufacturing enterprise shall be registered with the drug supervision and management department in the place where the sales take place. Sales shall produce the following certificates:
(a) stamped with the seal of the enterprise "medical device manufacturer license", "medical device product registration certificate" copy and product certification;
(b) 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 scope;
(C) the identity card of the salesperson.
Article VIII of the manufacturer's business name, legal representative or person in charge of the enterprise changes, the enterprise shall apply to the provincial Drug Administration for the "Medical Device Manufacturer License" after the change of procedures to the State Drug Administration to apply for the "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 packaging, the old packaging is to stop using, new and old packaging shall not be mixed.
Article IX manufacturers in the original site or off-site new construction, alteration, expansion of clean plants, by the location of the provincial drug supervision and management department 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 of the 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, suspension of production for more than two years, the certificate of registration of its products invalidated.
Article XI of the sample to observe or have been sold aseptic device products quality problems, the manufacturer must immediately seal the batch number of products, and notify the relevant units to stop sales and use. Cause personal injury or death, within 24 hours, report the location of the provincial drug supervision and management department.
Article XII of the supervision and inspection, found that the manufacturer does not meet the requirements of the "Rules for the Implementation of the Production", by the implementation of supervision and inspection of drug supervision and management departments ordered to rectify the deadline.
Article XIII The production enterprises shall not engage in the following behaviors:
(1) Counterfeiting or fraudulent use of other people's factory names, factory addresses or production enterprise documents;
(2) Renting or lending of the valid documents of the production enterprise;
(3) Procurement of parts and components or product packaging in violation of the provisions of the regulations;
(4) Counterfeiting or altering the production and purchase and sale of bills, production Original records, product batch number;
(e) non-conforming products, waste parts, expired or abandoned product packaging is not disposed of in accordance with the provisions;
(f) unauthorized increase in the product model, specifications;
(g) enterprise sales staff sales of products not produced by the enterprise;
(h) to the urban and rural markets to provide sterile devices or directly involved in the urban and rural markets sterile devices trade. Trade in sterile devices in urban and rural markets. Article XIV of the business enterprise shall have its business site and warehouse suitable for the operation of sterile devices. Product storage area should be protected from light, ventilation, pollution-free, with dust, pollution, mosquitoes and flies, insect and rodent prevention and prevention of foreign body mixing and other facilities, in line with product standards for storage.
Article XV of the operating companies should establish a quality tracking system for sterile devices, so that 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, type and specification, production batch number, sterilization batch number, product expiration date; operator, the person in charge of the signature and so on.
Article XVI of the operating companies should keep a complete record of the purchase and sale of sterile devices and valid certificates, sterile device purchase and sale records and valid certificates must be saved to the expiration of the product two years after the expiration date.
Article XVII of the operating enterprise sales staff sales of sterile devices, shall issue the following certificates:
(a) stamped with the seal of the enterprise "Medical Device Business Enterprise License", "Medical Device Product Registration Certificate" a copy of the product and the certificate of conformity;
(b) stamped with the seal of the enterprise and the enterprise's legal representative of the enterprise's legal representative's seal or signature, the entrustment of authorization The original authorization letter, the entrusted power of attorney shall specify the scope of its authorization;
(iii) the identity card of the salesperson.
Article XVIII of the operating enterprises found unqualified sterile devices, should immediately stop selling, and promptly report to the local drug supervision and management department. Verified as unqualified, the operating company must promptly notify the batch of sterile devices operating companies and use units to stop sales or use. Unqualified products should be dealt with under the supervision of the local drug supervision and management department.
On the unqualified sterile devices that have been sold for personal use, the operating enterprises should be announced to the community and take the initiative to withdraw the unqualified products.
Article 19 of the operating enterprises operating unqualified sterile devices, the operator can not specify the producer of substandard products, as the operation of the product without product registration certificate; can not specify the supplier of substandard products, as the purchase of products from the enterprise without the "medical device business license".
Article 20 The operation of aseptic devices shall not have the following acts:
(1) operating aseptic devices without valid certificates, incomplete certificates, and no product qualification certificates;
(2) forging or fraudulent use of the "Medical Devices Business Enterprise License";
(3) leasing or lending the "Medical Devices Business Enterprise License";
(4) operating Unqualified, expired or obsolete sterile devices;
(v) No purchase and sale records or forged or altered purchase and sale records;
(vi) Procurement of sterile devices from illegal channels;
(vii) Provision of sterile devices to urban and rural bazaars or direct participation in urban and rural bazaars sterile device trading. Article 21 medical institutions should be from the "medical device manufacturer license" or "medical device business enterprise license" of the enterprise to purchase sterile devices.
Medical institutions should establish a sterile device procurement, acceptance system, strict implementation and good records. Purchasing records should include at least: the name of the company purchasing the product, product name, model specifications, the number of products, production batch number, sterilization batch number, product expiration date and so on. According to the record should be able to trace the source of each batch of sterile instruments.
(a) Procurement of sterile instruments from the production enterprise, should be verified by the production enterprise sales staff issued by the certificate, the content of the certificate issued in accordance with the provisions of Article VII.
(B) from the business enterprise procurement of sterile devices, should be verified business enterprise sales staff issued by the certificate, the content of the certificate issued by the provisions of Article XVII.
Article 22 of the medical institutions should be established after the use of sterile instruments destruction system. Used sterile instruments must be destroyed in accordance with the provisions of the parts and components no longer have the use of function, disinfection and harmless treatment , and make a record.
Medical institutions shall not reuse sterile instruments.
Article 23 of the medical institutions found unqualified sterile devices, should immediately stop using, sealing, and promptly report to the local drug supervision and management department, shall not be disposed of without authorization.
Certified as unqualified sterile devices, under the supervision of the local drug supervision and management department to be dealt with.
Article 24 of the medical institutions to use unqualified sterile devices, can not specify the producer of substandard products, as the use of non-product registration certificate of the product; can not specify the supplier of substandard products, as the purchase of products from the enterprise without the "Medical Device Business License".
Article 25 of the use of sterile devices in medical institutions in the event of serious adverse events, should be within 24 hours after the event, report the location of the provincial drug supervision and management departments and health administrative departments.
Article 26 Medical institutions shall not engage in the following behaviors:
(1) Purchasing sterile devices from illegal channels;
(2) Using sterile devices whose small packages have been broken and poorly labeled;
(3) Using expired and obsolete sterile devices;
(4) Using sterile devices without the "Certificate of Registration of Medical Devices Products" or the Certificate of Conformity of Medical Devices Products. Certificate of Conformity of sterile devices. Article 27 The State Drug Administration is responsible for the preparation of the national sampling plan for sterile devices, and organize the implementation. Provincial Drug Administration is responsible for the preparation of this jurisdiction is responsible for the sampling plan for sterile devices, reported to the State Drug Administration for the record after the implementation of the organization.
State Drug Administration and the provinces, autonomous regions, municipalities directly under the Central Drug Administration to publish the results of sampling of sterile devices.
Article 28 The production, operation of enterprises and medical institutions have objections to the results of sampling, you can receive the test report within 15 days from the date of implementation of the sampling drug supervision and management department or the next level of drug supervision and management department to apply for re-inspection, the acceptance of re-inspection of drug supervision and management department to make a re-inspection of the conclusions. Article 29 The production of sterile devices without obtaining the "medical device product registration certificate", according to "supervision and management of medical devices regulations" Article 35 penalties.
Have obtained the "sterile device product registration certificate" of the enterprise new construction, alteration of plant production without authorization; forged others plant name, address, product batch number; forged or fraudulent use of "medical device product registration certificate", unauthorized increase in sterile device models, specifications, according to "Regulations for the Supervision and Management of Medical Devices" Article 35 penalties.
Article 30 does not obtain a "medical device manufacturer license" to produce sterile devices; forged or fraudulent use of others "medical device manufacturer license", according to "supervision and management of medical devices regulations" Article 36 penalties.
Article 31 The production of sterile devices does not meet the national standards or industry standards, according to "Regulations for the Supervision and Administration of Medical Devices" Article 37 penalties.
Article 32 does not obtain a "medical device business license" to operate sterile devices, according to "supervision and management of medical devices regulations" Article 38 penalties.
Article 33 The operation of no product registration certificate, no certificate of conformity, expired, expired, out of sterile devices, or from illegal channels to purchase sterile devices, according to "Regulations for the Supervision and Management of Medical Devices" Article 39 penalties.
Article 34 of the sterile device registration declaration, provide false certificates, documents, information, samples, or take other deceptive means to fraudulently obtain the certificate of registration of sterile device products, according to the "supervision and management of medical devices regulations" Article 40 penalties.
Article 35 The use of medical institutions without "medical device product registration certificate", no certificate of conformity, expired, invalid, out of sterile devices, or from illegal channels to purchase sterile devices, according to "Regulations for the Supervision and Management of Medical Devices" Article 42 penalties.
Article 36 of the medical institutions to reuse sterile devices, or should be destroyed without destruction, according to "supervision and management of medical equipment regulations" Article 43 penalties.
Article 37 The production of sterile devices, business enterprises and medical institutions in violation of the provisions of these Measures, one of the following acts, by the drug supervision and management departments at or above the county level shall order correction, give a warning and impose a fine of 10,000 yuan or more than 30,000 yuan or less:
(a) the production of production enterprises in violation of the "Production and Implementation Rules";
(b) the production enterprises to forge the Original product records and purchase and sale of bills;
(C) production enterprises selling other enterprises sterile devices;
(D) production and operation of the enterprise will be valid documents leased, lent to others to use;
(E) the operation of unqualified sterile devices;
(F) medical institutions did not establish a system of destruction after use, or falsification, alteration of the sterile device procurement
(vii) production, operation of enterprises, medical institutions to provide sterile devices to urban and rural markets or directly involved in urban and rural markets sterile device trading.
Article 38 of the sterile device manufacturers violate the provisions of the procurement of spare parts and product packaging or the sale of unqualified sterile devices, by the county-level drug supervision and management department shall be warned, ordered to make corrections, and impose a fine of 5,000 yuan or more than 20,000 yuan.
Article 39 of the sterile device business enterprises, no purchase and sale records or falsification of purchase and sale records, falsification of the production lot number, sterilization lot number, product expiration date, by the county-level drug supervision and management departments shall be warned and ordered to stop the operation of, and impose a fine of 5,000 yuan or more than 20,000 yuan.
Article 40 The production and operation of sterile devices and medical institutions in violation of the provisions of these measures, one of the following acts, by the drug supervision and management departments at or above the county level shall be ordered to make corrections, and given a warning:
(a) the discovery of unqualified sterile devices, do not report in accordance with the provisions of the unauthorized disposal;
(b) the discarded parts and components, expired or discarded product packaging, and do not In accordance with the provisions of the disposal;
(C) the operation or use of small packages have been broken, poorly labeled sterile devices;
(D) the use of sterile devices in the event of serious adverse events, do not report in accordance with the provisions of the report. Article 41 These measures by the State Drug Administration is responsible for the interpretation.
Article 42 These Measures shall be implemented from the date of promulgation.