(Promulgated on August 1, 2003 by Decree No. 5 of the Shanghai Municipal People’s Government)

Article 1 (Purpose)
With a view to strengthening the supervision and administration of disposable sterilized medical instruments, preventing iatrogenic diseases, guarding against environmental pollution, and protecting human health and the safety of life, these Provisions are formulated in accordance with the “Regulations on the Supervision and Administration of Medical Instruments”, taking into account the actual circumstances of this Municipality.
Article 2 (Definition)
Disposable sterilized medical instruments mentioned in these Provisions (hereinafter referred to as sterilized instruments) refer to the medical instruments that are registered as products according to the procedure for sterilized instruments, and are marked on the product packages with “Sterilized”, “Disposable”, or other similar expressions, such as Reuse Prohibited.
Article 3 (Application Scope)
These Provisions apply to the production, trading, use, and destruction of sterilized instruments, as well as activities of their supervision and administration.
Article 4 (Administrative Departments)
The Shanghai Drug Supervision Administration (hereinafter referred to as the SDSA) is the competent department in charge of the work of supervision and administration of the production, trading, use, and destruction of sterilized instruments in this Municipality. The district and county drug supervision administration are in charge of the work of supervision and administration of the production, trading, use, and destruction of sterilized instruments in their respective administrative areas.
The Shanghai Public Health Bureau is in charge of the organization, guidance and supervision of the use of sterilized instruments and their destruction in medical institutions in this Municipality.
Relevant administrative departments, including environmental protection and industrial and commercial administration shall join their efforts in ensuring the effective supervision and administration of sterilized instruments according to their respective duties.
Article 5 (Conditions for the Setting up of Enterprises)
In addition to meeting the conditions provided in Article 19 of the “Regulations on the Supervision and Administration of Medical Instruments”, the setting up of production enterprises of sterilized instruments shall also meet the following conditions:
（1）There are professional technicians who are familiar with the production of sterilized instruments, and more than two professional inspectors;
（2）There are air-conditioning and purifying systems, neat and tidy areas and a production environment that correspond with the production of sterilized instruments.
In addition to meeting the conditions provided in Article 23 of the “Regulations on the Supervision and Administration of Medical Instruments”, the setting up of the enterprises that operate sterilized instruments business shall also have place of business that correspond with their business operation of sterilized instruments, and accomplish that the place of business are separated from warehouses, and that the sterilized instruments in the warehouses are stored in areas separated from other medical instruments.
Article 6 (Requirements for the Quality System)
Sterilized instruments production enterprises that newly construct, reconstruct or extend their neat and tidy factory buildings on the original factory site or other sites shall have their quality system for sterilized instruments preliminarily examined, on-site examined, and their products spot checked and tested by the SDSA in accordance with relevant provision of the State.
Article 7 (Enterprise Quality Control Norm)
Sterilized instruments production enterprises shall organize their production in line with the special State requirements on the quality system for medical instruments, the production administration norm for sterilized medical instruments and the detailed implementation rules of production, and organize internal quality examination and verification on a regular basis.
Article 8 (Neat and Tidy Areas)
Sterilized instruments production enterprises shall exercise focused supervision and control over the neat and tidy areas in their production environment, and record timely such parameters as temperature, humidity and the number of bacteria colonies, so as to ensure that the production environment meets the requirements of the State on the production environment of sterilized instruments.
Article 9 (Raw Materials and Parts)
The raw materials and parts used by sterilized instruments production enterprises in the production of sterilized instruments shall meet the national standards or relevant requirements.
The raw materials and parts used by sterilized instruments production enterprises in the production of sterilized instruments shall be identical to those determined at the time of registration and approval. If it is necessary to change the raw materials or parts in the course of production, such changes shall be reported to the SDSA for the record. Where laws and regulations provide otherwise, such provisions shall prevail.
Sterilized instruments production enterprises shall check or test upon acceptance the quality of the raw materials and parts purchased.
Article 10 (Files of Batch Numbers of Products)
Sterilized instruments production enterprises shall establish files of the batch numbers of sterilized instruments. The files of the batch number of products shall include such data as the batch numbers of raw materials, production batch numbers, and sterilization batch numbers.
Files of the batch numbers of products shall be true and complete, and reflect accurately the whole process of the production. Files of the batch numbers of products shall be kept for a period of not less than two years after the expiry date of the effective period of the sterilized instruments.
Article 11 (Packaging)
Sterilized instruments production enterprises shall purchase packaging materials or small packages for sterilized instruments from those units that meet the conditions prescribed in the detailed implementation rules of production, and establish a management system covering the purchase, storage, distribution, use and other aspects of the packaging of products.
Small packages of sterilized instruments produced by sterilized instruments production enterprises shall be separately packed, containing the required amount for one time of use. It is prohibited to enclose in small packages reusable parts.
Article 12 (Labeling)
On the packages of sterilized instruments there shall be printed or stuck with labels of disposable sterilized instruments marked with the words “Sterilized”, “Disposable”, or symbols of Reuse Prohibited.
Labels of sterilized instruments shall contain approved instructions for use, and indicate the date of production, the production batch number, the sterilization method used, and the effective period.
Article 13 (Disposal of Disqualified Products)
Sterilized instruments production enterprises shall deform or destroy on the spot within their own premises disqualified products and parts, products that have expired or become ineffective, discarded small packages of products and their labels, and keep due records thereof.
After deforming on the spot disqualified products and parts, products that have expired or become ineffective, discarded small packages of products and their labels, the sterilized instruments production enterprises shall dispose of them as solid industrial wastes, and shall not dump or throw them away at will. Their disposal shall comply with relevant provisions on environmental protection.
Article 14 (Quality Tracking System)
Sterilized instruments production and operating enterprises shall establish a quality tracking system for sterilized instruments, and records of the marketing or purchase and sale of sterilized instruments shall be true and complete, so that the marketing or purchase can track the quality of every batch of products.
The marketing records of sterilized instruments production enterprises shall include the dates of sale, objects of sale, quantity of sale, name of products, model numbers and specifications, product batch numbers, sterilization batch numbers and the effective period of the products.
The purchase and sale record of sterilized instruments operating enterprises of sterilized instruments whose safety or effectiveness are subject to control or strict control, shall include the dates of purchase and sale, objects of purchase and sale, and quantity of purchase and sale, the names of products, production enterprises, model numbers and specifications, production batch numbers, sterilization batch numbers, the effective period of the product, and signatures of the handling person and the person in charge.
Product marketing records or purchase and sales records of sterilized instruments and their valid certificates shall be kept for not less than two years after the expiry of the effective period of the product.
Article 15 (Measures to Prevent Damages)
Sterilized instruments production enterprises, on discovering serious defects in the sterilized instruments they produce which can still endanger human health and personal safety even though used correctly, shall immediately suspend their production and stop their sales. Emergency measures shall be taken to inform the operating enterprises, medical institutions and users to suspend the sale or use of those already sold, recall all products of that batch number, and at the same time report the matter to the SDSA.
If the conditions referred to in the preceding clause exist in the sterilized instruments produced by sterilized instruments production enterprises, and the production enterprises, fail to take the measures prescribed in the preceding clause, the SDSA may require the production enterprises to suspend production, stop the sales of the products, and take measures to recall products with that batch number already sold.
On discovering serious defects in the sterilized instruments produced by sterilized instruments production enterprises, the relevant medical instruments trade associations may put forward appropriate suggestions to SDSA.
Article 16 (Annual Verification and Inspection)
When conducting annual examination of the “Permit for Medical Instruments Production Enterprises” in accordance with relevant provisions of the State, SDSA shall conduct concurrent verification and inspection on the implementation by the sterilized instruments production enterprises of the special requirements of the quality system for medical instruments, production management norms for sterilized instruments and detailed implementation rules of production.
Article 17 (Supervision and Monitoring of the Production Environment)
The drug supervision and administrative departments shall conduct routine supervision and monitoring of the environmental conditions in the neat and tidy areas of the sterilized instruments production enterprises in accordance with the State requirements for the production environment of sterilized instruments. On finding that the production environment of the sterilized instruments production enterprises does not meet the State requirements for the production environment of sterilized instruments, the drug supervision and administrative departments shall order them to make corrections within a time limit. In case the enterprises fail to make the corrections within the time limit, or remain disqualified even after the corrections, the drug supervision and administrative departments shall publicize them, and make records in the enterprise supervision and administration files.
When conducting routine supervision and checkups, the drug supervision and administrative departments shall follow the prescribed procedure. When conducting unannounced spot checks on sterilized instruments production enterprises, they shall produce on the spot the check-up notice.
When conducting routine supervision and checkups, the normal production and operational activities of the sterilized instruments production enterprises shall not be affected.
Article 18 (Check and Acceptance of Goods Purchased)
Medical institutions shall purchase qualified sterilized instruments from the sterilized instruments production and operating enterprises that are duly qualified according to law for the operation. The medical institution that purchase the second and third category sterilized instruments prescribed by the State shall purchase qualified sterilized instruments from the production and operating enterprises that have acquired the “Permits for Medical Instruments Production Enterprises” or the “Permits for Medical Instruments Operating Enterprises”, and verify the medical instrument registration certificates, product inspection certificates, and other markings of the products.
Medical institutions shall not purchase sterilized instruments that do not meet the prescribed requirements.
Article 19 (Requirements of Storage and Safekeeping)
Medical institutions shall take proper care of sterilized instruments in accordance with the requirements of the storage of sterilized instruments, and store them in areas separated from other medical instruments.
Article 20 (Checkups before Use)
Before using the sterilized instruments, medical institutions shall check up the packaging of sterilized instruments in accordance with the operating rules. In case damages are identified in the small packages of sterilized instruments or their effective period has expired, their use shall be stopped.
Article 21 (Files of the Use of Sterilized Instruments Implanted in Human Bodies)
Medical institutions shall establish files of the use of sterilized instruments implanted in human bodies.
Article 22 (Deformation and Disinfection after Use)
In case of sterilized instruments that may be deformed on the spot after use, medical institutions shall require the users to deform them on the spot; if deformation is impossible on the spot, they shall be deformed in a centralized manner within the medical institutions concerned. Sharp instruments, such as surgical knives, that can not be deformed shall be kept in special containers with marks of warnings.
Medical institutions shall disinfect sterilized instruments that are deformed, as well as those that cannot be deformed, and keep them in special containers with marks of warnings.
Article 23 (Centralized Destruction and its Record)
Medical institutions shall, in accordance with relevant provisions of the State and this Municipality, disinfect sterilized instruments that are deformed, as well as those that cannot be deformed, and then deliver them in a timely manner to institutions permitted by law to engage in disposing of medical wastes for centralized disposal by their destruction.
Medical institutions shall keep record of the sterilized instruments turned over for destruction.
Article 24 (Prohibited Acts)
Medical institutions shall not do the following acts:
（1）Reuse the sterilized instruments;
（2）Fail to destroy the used sterilized instruments that shall be destroyed;
（3）Sell the used sterilized instruments to other people;
（4）Dump or throw away at will the used sterilized instruments;
（5）Turn the used sterilized instruments over to parties other than their own institutions for disposal without first deforming and disinfecting them.
Article 25 (Administrative Punishment for Wrongful Acts in Production and Operation)
In case of any of the following acts in violation of these Provisions, the drug supervision and administrative departments shall order them to be corrected, and cumulatively impose a fine of between not less than 1,000 yuan and not more than 30,000 yuan, depending on the seriousness of the case:
（1）Sterilized instruments production enterprises fail to use separate packages containing the quantity for one time of use, or they enclose reusable parts in the small packages;
（2）Sterilized instruments production enterprises fail to deform or destroy the disqualified products and parts, products that have expired or become ineffective, discarded small packages of products and their labels.
In case of any one of the following acts in violation of these Provisions, the drug supervision and administrative departments shall order them to be corrected within a time limit. In case they fail to make correction within the time limit, they may be given a warning or a fine of not more than 5,000 yuan may be imposed:
（1）Sterilized instruments production enterprises fail to establish files of product batch numbers, or forge files of product batch numbers;
（2）Sterilized instruments production enterprises fail to print or stick labels of disposable sterilized instruments on the packages of the sterilized instruments they produce in accordance with the provisions;
（3）Sterilized instruments production and operating enterprises fail to establish records of the marketing or purchase and sale of products, or forge records of the marketing or purchase and sale of products.
Sterilized instruments production enterprises that dump or throw away at will disqualified products and parts, products that have expired or become ineffective, discarded small packages of products and their labels, or dispose of them in violation of relevant provisions on environmental protection shall be punished by the environmental protection administrative departments in accordance with law.
Article 26 (Administrative Punishment for Violations of Law in Use or Destruction)
Medical institutions that are in any one of the following situations shall be punished by the drug supervision and administrative departments according to the provision of Article 43 of the “Regulations on the Supervision and Administration of Medical Instruments”:
（1）Reuse sterilized instruments;
（2）Fail to destroy used sterilized instruments that shall be destroyed.
Medical institutions that are in any one of the following situations shall be ordered by the drug supervision and administrative departments to make corrections and maybe accumulatively penalized with a fine of between not less than 1,000 yuan and not more than 30,000 yuan, depending on the seriousness of the case:
（1）Sell used sterilized instruments to other people;
（2）Turn over used sterilized instruments to parties other than their own institutions for disposal without first deforming and disinfecting them;
（3）Unable to prove that the used sterilized instruments have been disposed of through lawful channels.
Medical institutions that are in any one of the following situations shall be ordered by the drug supervision and administrative departments to make corrections; in case they fail to make correction within a time limit, they may be given warnings or be penalized with a fine of not more than 5,000 yuan:
（1）Fail to record the used sterilized instruments turned over for disposal;
（2）Fail to place, keep or store the sterilized instruments in accordance with the provisions.
Medical institutions that dump or discard used sterilized instruments at will in violation of relevant provisions on environmental protection or dispose of used sterilized instruments in violation of law shall be punished by the environmental protection administrative departments according to law.
Article 27 (Effective Date)
These Provisions shall become effective on October 1, 2003.