(a) the production and operation of medical devices without obtaining the certificate of registration of medical devices of the second class, the third class of medical devices;
(b) unauthorized to engage in the production of the second class, the third class of medical devices activities;
(c) Unauthorized to engage in Class III medical device business activities.
The first paragraph of the preceding circumstances, the circumstances are serious, by the original licensing department to revoke the medical device manufacturing license or medical device license.
Article 64 Provide false information or take other deceptive means to obtain a medical device registration certificate, medical device manufacturing license, medical device license, advertising approval documents and other licenses, by the original licensing department to revoke the licenses that have been obtained, and impose a fine of 50,000 yuan or more than 100,000 yuan or less, and within five years will not be accepted by the person responsible for the relevant and the enterprise to submit the application for licensing of medical devices.
Forgery, alteration, trading, leasing, lending of medical device license, the original licensing department shall be seized or revoked, confiscate the illegal income; illegal income of less than 10,000 yuan, a fine of 10,000 yuan above 30,000 yuan; more than 10,000 yuan of illegal income, a fine of more than three times the illegal income of five times the fine; constitute a violation of law and order management, by the public security organs according to law to be Public security management penalties.
Article 65 is not filed in accordance with the provisions of these Regulations, by the people's governments at or above the county level food and drug supervision and management department shall order rectification within a specified period of time; failure to do so shall result in the announcement of the name of the unit and product not filed to the public, and may be subject to a fine of less than 10,000 yuan.
Provide false information for the record, by the people's government at or above the county level, food and drug supervision and management department of the public announcement of the filing of the unit and the name of the product; the circumstances are serious, the person directly responsible for the five years shall not be engaged in the production and operation of medical equipment activities.
Article 66 of the following circumstances, by the people's governments above the county level food and drug supervision and management department shall order rectification, confiscate the illegal production, operation or use of medical devices; illegal production, operation or use of medical devices less than 10,000 yuan, and impose a fine of 20,000 yuan more than 50,000 yuan; value of 10,000 yuan or more and impose a value of more than 5 times the amount of 10 times the fine; serious cases shall be liable to a fine of less than 10 times; and shall impose a fine of more than 10 times the amount of 10,000 yuan. The circumstances are serious, shall order the suspension of production and business, until the original licensing department to revoke the medical device registration certificate, medical device manufacturing license, medical device license:
(a) the production, operation and use of medical devices do not meet the mandatory standards or do not meet the technical requirements of the products by the registration or filing;
(b) the medical device manufacturer is not in accordance with the technical requirements of the products by the registration or filing of the organization of medical devices. Registered or filed product technical requirements for the organization of production, or not in accordance with the provisions of these regulations to establish a quality management system and maintain effective operation;
(c) the operation, use of no qualification documents, expired, expired, out of medical devices, or the use of medical equipment is not registered in accordance with the law;
(d) food and drug supervision and management authorities ordered in accordance with the provisions of this regulation to implement Recall or stop operating, but still refused to recall or stop operating medical devices;
(E) entrusted the production of medical devices do not have the conditions set out in these Regulations, or the entrusted party's production behavior is not managed.
Article 67 One of the following circumstances, the food and drug administration department of the people's government at or above the county level shall order correction, impose a fine of 10,000 yuan or more than 30,000 yuan; if the circumstances are serious, shall order the suspension of production and business, until the original licensing department revoke the license to manufacture medical devices, medical device license:
(1) the production conditions of the medical device manufacturer has changed, 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 production, reporting;
(b) the production and operation of instructions, labeling does not comply with the provisions of this regulation of medical devices;
(c) not in accordance with the requirements of the medical device instructions and labeling requirements for the transport and storage of medical devices;
(d) the transfer of expiration, expiration, Out or test failed medical devices in use.
Article 68 of the following circumstances, by the people's government at or above the county level, food and drug supervision and management departments and the competent departments of health and family planning in accordance with their respective responsibilities and ordered to make corrections, and give a warning; refusal to make corrections, shall be sentenced to a fine of 5,000 yuan or more than 20,000 yuan; the circumstances are serious, shall be ordered to suspend the production and business, or by the original department of the license to cancel the production license of medical devices, medical equipment business license:
(a) medical device manufacturers are not required to submit quality management system self-inspection report;
(b) medical device business enterprises, the use of units in accordance with the provisions of this regulation to establish and implement the medical device purchase inspection records system;
(c) engaged in the second, third class medical device wholesale business and third class medical device retail business operation Enterprises not in accordance with the provisions of these Regulations to establish and implement the sales record system;
(D) the reuse of medical devices, medical equipment using units are not in accordance with the provisions of the disinfection and management of the treatment;
(E) the reuse of medical equipment using units of single-use medical devices, or not in accordance with the provisions of the destruction of used single-use medical devices;
(F) the need for regular inspection, testing, calibration, maintenance, maintenance of medical devices, medical devices, medical devices, units are not in accordance with the requirements of the product specification inspection, testing, calibration, maintenance, maintenance and record, timely analysis, evaluation, to ensure that the medical device is in good condition;
(VII) medical devices, medical devices, units are not properly preserved to purchase Class III medical devices, the original information Information, or not in accordance with the provisions of large medical devices and implantable and interventional medical devices information recorded in medical records and other relevant records;
(h) medical device use unit found the use of medical devices have safety risks not immediately stop using, notify the overhaul, or continue to use the overhaul can not meet the use of safety standards of medical devices;
(ix) Medical device manufacturers and operators, the use of units not in accordance with the provisions of these regulations to carry out monitoring of adverse events of medical devices, not in accordance with the requirements of the report of adverse events, or monitoring of adverse events of medical devices, food and drug supervision and management departments to carry out the investigation of adverse events do not cooperate.
Article 69 Violation of the provisions of these regulations to carry out clinical trials of medical devices, by the people's government at or above the county level food and drug supervision and management department shall order correction or immediately stop the clinical trial, and may impose a fine of 50,000 yuan; cause serious consequences, according to law on the directly responsible personnel in charge of the person in charge and other personnel directly responsible for the demotion, dismissal, or dismissal of the sanction; there are medical device clinical trial organization qualification, by the granting of its qualification. Agency qualification, by the competent authority to grant its qualification to revoke the qualification of medical device clinical trial organization, 5 years will not accept its application for accreditation.
Medical device clinical trial organization issued a false report, by the competent authority to grant its qualification to revoke the qualification of medical device clinical trial organization, within 10 years will not accept its application for accreditation; by the people's government at or above the county level of food and drug supervision and management department of the more than 50,000 yuan of 100,000 yuan or less fine; there is illegal income, the confiscation of the illegal income; directly responsible for the supervisor and other personnel in charge, shall be given dismissal or dismissal or dismissal, and shall be punished according to law. responsible personnel, shall be given the punishment of dismissal or expulsion.
Article 70 of the medical device inspection agency issued a false test report, by the competent authority to grant its qualification to revoke the inspection qualification, 10 years will not accept its application for accreditation; impose a fine of 50,000 yuan or more than 100,000 yuan; there is illegal income, confiscate the illegal income; directly responsible for the supervisory staff and other personnel directly responsible for the law shall be given to the dismissal or dismissal of the sanctions; dismissal of the sanctions, from the decision on the sanctions, from the time of the decision on the dismissal of the medical device inspection agency. Punishment, from the date of the disciplinary decision shall not be engaged in medical device inspection work within 10 years.
Seventy-one violation of the provisions of these Regulations, the release of medical device advertisements without obtaining the approval of documents, without prior verification of the authenticity of the approval of the document that is published medical device advertisements, or published advertisements and approval of the content of the medical device advertisements are inconsistent with the documents, by the administration for industry and commerce in accordance with the provisions of the relevant laws and administrative regulations on the management of advertising shall be punished.
Tampering with the contents of the approved medical device advertisement, the original licensing department shall revoke the approval document of the advertisement of the medical device, and shall not accept the application for approval of the advertisement within 2 years.
If a false medical device advertisement is published, the food and drug administration department of the people's government at or above the provincial level shall decide to suspend the sale of the medical device and make it known to the society; if the medical device is still sold, the food and drug administration department of the people's government at or above the county level shall confiscate the illegal sale of the medical device and impose a fine of 20,000 yuan or more than 50,000 yuan.
Article 72 The medical device technical review organization, medical device adverse event monitoring technical institutions not in accordance with the provisions of this regulation to perform their duties, resulting in review, monitoring work of major errors, by the people's government at or above the county level food and drug supervision and management department ordered to make corrections, notification of criticism, given a warning; cause serious consequences, the directly responsible for the supervisor and other personnel directly responsible for. According to law to give demotion, dismissal or dismissal of punishment.
Article 73 The food and drug supervision and management departments and their staff shall, in strict accordance with the types and range of penalties provided for in these regulations, in accordance with the nature of the violation and the specific circumstances of the exercise of the right to administrative penalties, the specific measures shall be formulated by the State Council food and drug supervision and management departments.
Article 74 violation of the provisions of these regulations, the people's government at or above the county level, food and drug supervision and management departments or other relevant departments do not perform the supervision and management of medical devices or abuse of power, dereliction of duty, favoritism and malpractice, by the supervisory organ or appointment and removal of the organ directly responsible for the competent personnel and other personnel directly responsible for the law to give a warning, a demerit or a major fault of the punishment; resulting in serious consequences, a demotion, demotion, or a major fault of the person concerned. In case of serious consequences, the person shall be demoted, dismissed or expelled.
Article 75 Violation of the provisions of these Regulations, constitutes a crime, shall be investigated for criminal responsibility; caused personal, property or other damage, shall bear the liability for compensation.