Article 10 The legal representative, person in charge and quality management personnel of an enterprise shall be familiar with the laws, regulations, rules and norms on the supervision and management of medical devices and the relevant knowledge of the medical devices they operate, meet the qualification requirements stipulated in relevant laws and regulations and this specification, and have not been prohibited from practicing by relevant laws and regulations.
Article 11 An enterprise shall have a quality management organization or quality management personnel suitable for its business scope and scale, and the quality management personnel shall have relevant professional qualifications or titles recognized by the state.
The person in charge of the quality of the third type of medical device business enterprise shall have a college degree or above or an intermediate title or above (related majors refer to medical devices, biomedical engineering, machinery, electronics, medicine, bioengineering, chemistry, pharmacy, nursing, rehabilitation, laboratory science, management, etc.). , the same below), and should have more than 3 years of experience in quality management of medical device business.
Article 12 An enterprise shall set up or equip personnel for key positions such as quality management and operation that are suitable for its business scope and scale and meet relevant qualification requirements. Personnel engaged in quality management of third-class medical device enterprises shall be on duty.
(1) Among the quality management personnel engaged in in in-vitro diagnostic reagents, there should be 1 person in charge of inspection, or have a college degree or above in inspection and have been engaged in inspection-related work for more than 3 years. Personnel engaged in the acceptance and after-sales service of in-vitro diagnostic reagents shall have technical secondary school education or primary professional titles of inspectors.
(2) Personnel engaged in the operation of implantable and interventional medical devices shall be equipped with personnel with college degree or above in medical related major and trained by manufacturing enterprises or suppliers.
(3) Operators of medical devices with special requirements, such as contact lenses and hearing AIDS, shall have relevant professional or professional qualifications.
Article 14 An enterprise shall conduct pre-job training and continuing training for quality leaders and personnel in various positions related to their duties and work contents, establish training files, and take up their posts only after passing the examination. The training content should include relevant laws and regulations, professional knowledge and skills of medical devices, quality management system, responsibilities and post operation procedures, etc.
Extended data:
The state implements classified management of medical devices according to the degree of risk:
The first category is low-risk medical devices, which can be guaranteed to be safe and effective through routine management.
The second category is medium-risk medical devices, which need strict control and management to ensure their safety and effectiveness.
The third category is high-risk medical devices, which need to be strictly controlled and managed by special measures to ensure their safety and effectiveness.
Commonly used medical instruments in hospitals: trauma treatment vehicles, operating tables, operating lights, monitors, anesthesia machines, ventilators, blood cell analyzers, differentiation analyzers, enzyme-labeled instruments, cleaning machines, urine analyzers, ultrasonic instruments (color ultrasound, B ultrasound, etc. ), X-ray machine, nuclear magnetic resonance, etc.
References:
Baidu Encyclopedia-Quality Management Standard for Medical Device Management
References:
Baidu encyclopedia-medical equipment