Medical Device Supervision and Administration Regulations (6)

Article 84 of the following circumstances, by the department responsible for drug supervision and management to the public announcement of the name of the unit and the product, and ordered to make corrections within a period of time; overdue correction, confiscate the illegal income, illegal production and operation of medical devices; illegal production and operation of medical devices less than 10,000 yuan of the value of the goods and impose a fine of 10,000 yuan of more than 50,000 yuan; value of 10,000 yuan of more than 10,000 yuan of the value of goods and impose a 5 More than 20 times the amount of fine; the circumstances are serious, the legal representative of the illegal unit, the main person in charge, directly responsible for the competent personnel and other responsible persons, confiscate the illegal behavior during the period from the unit's income, and impose a fine of more than 30% of the income earned 2 times the following fine within 5 years prohibited from engaging in the production and operation of medical equipment activities:

(a) the production and operation of the first class of medical devices without the record Medical devices;

(b) engaged in the production of Class I medical devices without filing;

(d) has been filed information does not meet the requirements.

Article 85 of the filing of false information provided by the drug supervision and management department responsible for the public announcement of the filing unit and product name, confiscate the illegal income, illegal production and operation of medical devices; illegal production and operation of medical devices less than 10,000 yuan in value and impose a fine of 20,000 yuan more than 50,000 yuan; more than 10,000 yuan in value and impose a fine of 5 times the amount of more than 20 times the amount of the goods Fines; the circumstances are serious, ordered to suspend production and business, the legal representative of the illegal unit, the main person in charge, directly responsible for the competent personnel and other responsible personnel, confiscate the illegal behavior during the period from the unit's income, and impose a fine of more than 30% of the income earned more than three times the following fine for 10 years prohibited from engaging in the production and management of medical equipment activities.

Article 86 of the following circumstances, by the drug supervision and management department responsible for ordering correction, confiscation of illegal production and operation of medical devices; illegal production and operation of medical devices less than 10,000 yuan in value, and impose a fine of 20,000 yuan more than 50,000 yuan; value of more than 10,000 yuan, and impose a fine of more than 5 times the amount of more than 20 times the amount of the fine; the circumstances are serious, shall be ordered to cease production Suspension of business, until the original licensing department to revoke the medical device registration certificate, medical device manufacturing license, medical device license, the legal representative of the illegal unit, the main person in charge, directly responsible for the competent person and other responsible personnel, confiscate the illegal behavior during the period of time from the unit's income, and impose a fine of more than 30% of the income obtained more than three times the following fine for 10 years to prohibit them from engaging in the production of medical equipment business activities. Activities:

(a) the production, operation and use of medical devices do not meet the mandatory standards or do not meet the technical requirements of the registered or filed products;

(b) not in accordance with the technical requirements of the registered or filed products to organize the production, or not in accordance with the provisions of these Regulations to establish a quality management system and maintain effective operation, affecting product safety, effectiveness;

(c) the operation and use of no qualification documents, expired, outdated or not in accordance with the provisions of the Regulations, and to maintain effective operation. Qualification documents, expired, invalid, obsolete medical devices, or the use of medical devices not registered in accordance with the law;

(d) in the drug supervision and management department responsible for ordering the recall still refused to recall, or in the drug supervision and management department responsible for ordering the cessation or suspension of the production, import, operation, still refused to stop the production, import, operation of medical devices;

(e) entrusted enterprises that do not have the conditions set out in the regulations for the production of medical devices. Regulations provide the conditions for the production of medical devices, or not entrusted to the production of enterprises to manage the production behavior;

(F) the import of expired, invalid, out of use and other medical devices have been used.

Article 87 of the medical device business enterprises, the use of units to fulfill the provisions of these regulations such as purchase inspection obligations, there is sufficient evidence to prove that it is not aware of the operation, use of medical devices for the first paragraph of Article 81, paragraph 1 (a) of Article 84 (a), Article 86 (a) and (b) of the circumstances of the medical device, and can truthfully explain the source of its purchase, the seizure of the operation, use of medical devices. Medical devices that do not meet the statutory requirements, can be exempted from administrative penalties.

Article 88 of the following circumstances, by the department responsible for drug supervision and management shall order correction, impose a fine of 10,000 yuan or more than 50,000 yuan; refused to make corrections, impose a fine of 50,000 yuan or more than 100,000 yuan; the circumstances are serious, shall order the suspension of production and shutdown, until the original issuance of the department revoked the medical device production license, the medical device license, the legal representative of the offending unit, the main responsible person directly responsible for the competent person and other responsible personnel, confiscate the illegal behavior during the period from the unit's income, and impose a fine of more than 30% of the income earned 2 times the following 5 years prohibited from engaging in the production and operation of medical devices:

(a) production conditions change, no longer meet the requirements of the quality management system for medical devices, not in accordance with the provisions of these regulations to rectify, stop the production of the report;

(B) the production and operation of manuals, labels do not meet the provisions of these regulations of medical devices;

(C) not in accordance with the instructions and labels of medical devices labeling requirements for the transportation and storage of medical devices;

(D) transfer of expired, expired, eliminated, or failed to test the medical devices in use.

Article 89 of the following circumstances, by the drug supervision and management departments and health departments in charge of their respective responsibilities and ordered to correct, given a warning; refused to correct, a fine of 10,000 yuan or more than 100,000 yuan; the circumstances are serious, ordered to suspend production and business, until the original licensing department revoked the registration of medical devices, medical device manufacturing license, medical device license, the illegal units The legal representative, the main person in charge, directly responsible for the competent person and other responsible personnel shall be fined more than 10,000 yuan 30,000 yuan:

(a) not in accordance with the requirements of the quality management system to submit a self-inspection report;

(b) from the supplier does not have the legal qualifications to purchase medical devices;

(c) medical equipment business enterprises, the use of units in accordance with the provisions of these regulations to establish and implement Medical device purchase inspection record system;

(d) engaged in the second and third class medical device wholesale business and the third class medical device retail business business enterprises are not in accordance with the provisions of this regulation to establish and implement the sales record system;

(e) medical device registrants, filers, production and operation of enterprises, the use of units in accordance with the provisions of this regulation to carry out monitoring of adverse events of medical devices, failure to report adverse events, or to medical devices. Requirements to report adverse events, or adverse events monitoring of medical devices technical institutions, responsible for drug supervision and management of the department, the competent department of health to carry out the investigation of adverse events do not cooperate;

(F) medical device registrants, filers are not in accordance with the provisions of the development of post-marketing research and risk management and control program and ensure effective implementation;

(G) medical device registrants, filers are not in accordance with the provisions of the establishment and implementation of product traceability system;

(G) medical device registrants, filers are not in accordance with the provisions of the establishment and Implementation of product traceability system;

(viii) medical device registrants, filers, business enterprises engaged in the sale of medical devices network is not in accordance with the provisions of the notification of the drug supervision and management departments responsible for;

(ix) need to be regularly checked, inspection, calibration, maintenance, maintenance of medical devices, medical devices, medical devices, the use of units are not in accordance with the requirements of the product specification for checking, inspection, calibration, maintenance, repair and be recorded, timely analysis and evaluation, and to ensure the effectiveness of the product. Records, timely analysis, assessment, to ensure that the medical device is in good condition;

(J) medical device user units do not properly save the purchase of Class III medical devices of the original information.

Article 90 of the following circumstances, by the people's governments at or above the county level, the competent health department shall order correction, give a warning; refused to make corrections, impose a fine of 50,000 yuan of more than 100,000 yuan; the circumstances are serious, impose a fine of 100,000 yuan of more than 300,000 yuan, and order the suspension of the use of relevant medical devices, until the original licensing department revoke the license, and the relevant responsible personnel shall be suspended six months or more than one year of practice activities. months or more than 1 year or less of practice activities, until the original licensing department revoke the license of the relevant personnel, the legal representative of the offending unit, the main person in charge, directly responsible for the competent personnel and other responsible personnel, confiscate the illegal behavior during the period of time from the unit's income, and impose a fine of more than 30% of the income obtained more than three times the amount of the fine imposed in accordance with the law:

(a) for the reuse of medical devices, the Medical device use units not in accordance with the provisions of sterilization and management of treatment;

(b) medical device use units reuse of single-use medical devices, or not in accordance with the provisions of the destruction of used single-use medical devices;

(c) medical device use units not in accordance with the provisions of the large-scale medical devices, as well as implantable and interventional medical devices, information documented in the medical record and other relevant records

(d) the use of medical devices found in the use of medical devices there are potential safety problems did not immediately stop using, notify the maintenance, or continue to use the maintenance still can not meet the safety standards for the use of medical devices;

(e) the use of medical devices in violation of the use of large-scale medical equipment can not guarantee the quality of health care and safety.