Interim Provisions On The Implantable Medical Device Administration Of Gansu Province

Original Language Title: 甘肃省植入性医疗器械监督管理暂行规定

Subscribe to a Global-Regulation Premium Membership Today!

Key Benefits:

Subscribe Now for only USD$40 per month.
(November 30, 2006, the 92nd meeting of the people's Government of Gansu Province passed on December 10, 2006 32nd release of Gansu province as of January 1, 2007) first in order to strengthen the supervision of implantable medical devices, protecting people's health and use of medical device safety, according to the regulation on supervision and administration of medical devices and related laws and regulations, combined with the facts of the province, these provisions are formulated.
    Implantable medical devices referred to in the provisions of article refers to any aid surgery instruments in whole or in part into the body or in a natural cavity, stay in the body for a long time after the end of the surgical procedure, or at least 30th medical devices remain in the body.
    Article where in the province engaged in within the administrative area of implantable medical device manufacturing, operation and use of the units or individuals shall abide by these provisions.
    The fourth pharmaceutical supervisory and administrative departments at and above the county level shall be responsible for the supervision and management of implantable medical devices within the administrative area. Fifth production of an implantable medical device companies should be approved by the provincial drug supervision and management departments to review and issue a medical device manufacturing enterprise license.
    Without the medical device manufacturing enterprise license, shall be granted by the Administrative Department for industry and commerce business license.
    Production of implantable medical device shall obtain the registration certificate, the implementation of national standards or trade standards, according to national related production practices to organize production. Article sixth of an implantable medical device companies should be approved by the provincial drug supervision and management departments to review and issue a medical device distributing Enterprise license.
    No medical device distributing Enterprise license, shall be granted by the Administrative Department for industry and commerce business license.
    Seventh use of implantable medical device medical institutions should be issued by the administrative departments of public health of the practising certificate for medical institution approved and registered by the medical subjects is consistent, and should have an implantable medical device production, operating legally qualified purchase has the registration certificate of medical devices for implantable medical devices.
    Article eighth of implantable medical device manufacturing enterprises, trading enterprises and medical institutions should establish the procurement, inspection, storage, sale, storage, conservation, use and management, user registration, follow-up, quality tracking, destruction, substandard products, adverse event reporting and other management systems.
    Nineth medical device distributing Enterprise buy implantable medical device and medical institutions, shall examine the supplier of medical device manufacturing enterprise license or medical device distributing Enterprise license, product certification, product registration and other documents.
    Article tenth of implantable medical device manufacturing enterprise, enterprise storage of implanted medical devices, and medical institutions should conform to product storage conditions, store, and clearly identified. 11th acceptance of incoming and outbound sales or use a detailed traceability must be recorded and kept.
    Records include the purchase and sale of (using) date, product name, specification, quantity, manufacturer or dealer, sold in units (departments), serial number, lot number, or individual products, sterilization lot number, period of validity, quality certificates, packaging, labeling, packaging, and acceptance (delivery), custodian, reviews (receiving) signature, and so on. 12th before clinical use of implantable medical devices, medical personnel must be the illness, medical practices, using instruments, disclosure of medical risk patients or their families, and were signed informed consent by patients or their families.
    Includes: patient's basic situation, product name, production unit, implanted medical devices the possibility of risks and the possible consequences, responses, patients or their families, signature, and so on. 13th medical institutions are using legitimate qualifying product liability. Medical agencies shall not use medical devices to the patients or their families.
    Medical institutions to patients using medical devices should be handled by unified purchase and management of medical institutions and integrated into comprehensive health care services to patients. 14th medical institutions should be developing an implantable medical device registration system. Implantable medical device in clinical usage must be registered after use, ensure product quality information tracking. Records include: patient name, operation name, surgery, patient medical record number, address, contact phone number and other products using date (date of surgery), the names, specifications, types, quantity, production batch, sterilization lot number, expiry date, producers, suppliers, product packaging, a single serial number and so on.
    Records should be stored with the records. 15th medical institutions of implanted medical devices should be used according to the product's design and use requirements for implant installation.
    Without qualified medical workers engaged in an implantable medical device implant installation work.
    16th implantable medical device manufacturing enterprises or enterprises should establish a medical device quality tracking system, making quality follow-up cards, collect quality information at the right time.
    17th no duplicate use of implantable medical devices, use of implanted medical devices, medical institutions should be destroyed in accordance with the relevant provisions, and record the product name, quantity, timing, modalities, implementation of such destruction. 18th implantable medical device manufacturing enterprises, trading enterprises and medical institutions should establish the adverse event reporting system.
    Medical device adverse event occurred, related to the production, sale and use of medical devices should be in accordance with the prescribed time limit, content, procedures and management rights, reported to the drug regulatory Department and the Administrative Department of public health.
    19th medical institution can occur as a result of implanted medical device or implantable medical device may be causing serious injury or death, should be reported within 24 hours of drug supervision and Management Department and the Administrative Department of public health.
    A medical institution shall conduct a preliminary analysis of the reasons for adverse events, complete medical device adverse event reporting form, 10th in the drug regulatory Department and the Administrative Department of public health.
    Pharmaceutical supervisory and Administrative Department of the people's Government above the county level have resulted in medical device quality accidents or accidents may cause medical devices quality products and related information, can be sealed up or seized. 20th adverse events prior to the identified causes, medical device manufacturing enterprises, trading enterprises and medical institutions to respond to adverse events of the same specification models stock products, suspension of sales, use, and the registration of surplus seal, and reported to the pharmaceutical supervisory and administrative department.
    After the incident causes, products of the pharmaceutical supervisory and administrative departments shall make, and shall inform the relevant units.
    Article 21st of implantable medical device manufacturing enterprises, trading enterprises and medical institutions in violation of the provisions stipulated in the Nineth and tenth, pharmaceutical supervisory and administrative departments at and above the county level shall give it a warning, and a fine of 1000 Yuan more than 5000 Yuan fine.
    Article 22nd of implantable medical device manufacturing enterprises, trading enterprises and medical institutions in violation of the provisions set forth in the 19th, 20th, by the pharmaceutical supervisory and administrative departments at and above the county level shall give warning, rectification; fails to change, fined 10,000 yuan fine.
    23rd implantable medical device manufacturing enterprises, trading enterprises and medical institutions in violation of the provisions of other acts, laws, regulations, penalties, from its provisions.
                                                                                                                            24th article this provision come into effect on January 1, 2007.