Article 53 violation of the provisions of these measures, did not obtain "medical device manufacturer license" to produce the second class, the third class of medical devices, in accordance with "supervision and management of medical devices regulations" Article 36 punishment.
Not obtain a medical device registration certificate for the production of medical devices, in accordance with the "supervision and management of medical equipment regulations" Article 35 punishment.
Article 54 violation of the provisions of this Measures altered, sold, rented, loaned or otherwise illegally transferred "medical device manufacturer license" by the county level or above (food) drug supervision and management department ordered to correct, and may impose a fine of 10,000 yuan or more than 30,000 yuan; for the use of altered, sold, rented, loaned or otherwise illegally transferred "medical device manufacturer license", shall order the manufacturer to pay a fine of $ 1,000,000, or more than 30,000 yuan. Enterprise License", shall order its correction, which is not obtained "Medical Device Manufacturer License" to produce Class II, Class III medical devices
mechanical, in accordance with the "Supervision and Administration of Medical Devices Regulations" Article 36 penalties.
Article 55 The applicant to conceal the relevant information or provide false materials to apply for a "medical device manufacturer license", the province, autonomous region, municipality directly under the Central (food) drug supervision and management department shall not be accepted or not approved, and give a warning, the applicant shall not apply for a "medical device manufacturer license" again within one year.
Deception, bribery and other improper means to obtain a "medical device manufacturer license" by the original licensing authority to revoke the "medical device manufacturer license"; has been carried out in accordance with the "supervision and management of medical equipment regulations" Article 36 penalties; the applicant shall not apply for the administrative licensing within three years again.
Article 56 The production of medical devices does not meet national standards, industry standards and registered product standards, in accordance with the "supervision and management of medical equipment regulations" Article 37 penalties.
Article 57 The medical device manufacturer of one of the following circumstances, by the location of the county above the (food) drug supervision and management department shall give a warning, and ordered to make corrections within a specified period of time, and may impose a fine of up to 30,000 yuan:
(a) the first class of medical devices manufacturer did not follow the provisions of the (food) drug supervision and management department in writing;
(b) not in accordance with the Standards for testing or products leaving the factory without a certificate of conformity;
(C) not in accordance with the provisions of the "Medical Device Manufacturer License" change procedures;
(D) violation of the relevant requirements for the quality management of medical device production, unauthorized reduction in the production conditions;
(E) not in accordance with the provisions of this approach to the registration record unauthorized commissioned or commissioned production of medical devices;
(F) the production of medical equipment, medical equipment, medical equipment, medical equipment and other medical equipment;
(F) in the unauthorized production site unauthorized production of medical devices;
(VII) the production of Class III medical devices are not in accordance with the provisions of the establishment of a post-marketing tracking system;
(VIII) did not comply with the provisions of the report on the occurrence of major quality incidents of medical devices;
(IX) listing of medical devices there is a major safety hazard and not rectified;
< p> (J) medical device manufacturers to suspend production for more than one year, without prior written notice of the location of the province, autonomous region, municipality directly under the Central (food) drug supervision and management department that resumed production;(K) to the supervision and inspection of the (food) drug supervision and management department responsible for concealing the relevant information, providing false materials or refusing to provide a true reflection of the activities of the material.
Medical device manufacturers have the circumstances listed in the preceding paragraph, the circumstances are serious or cause harmful consequences, is a violation of the "supervision and management of medical devices regulations" related provisions, in accordance with the "supervision and management of medical devices regulations" shall be punished.
Article 58 In the implementation of the administrative licensing of the provisions of these measures in violation of relevant laws and regulations, in accordance with relevant laws and regulations.
Article 59 (food) drug supervision and management department staff abuse of power, favoritism, dereliction of duty, constitutes a crime, according to the relevant provisions of the Criminal Law by the judicial department to pursue criminal responsibility; does not constitute a crime, the competent departments shall be given administrative sanctions.