The person in charge of quality of medical device business enterprise should have medical device related professional (related professional refers to medical devices, biomedical engineering, machinery, electronics, medicine, bioengineering, chemistry, pharmacy, nursing, rehabilitation, testing, computers, law, management and so on) college degree or above, or more than intermediate professional and technical title. The legal representative can also be understood as an investor, without limiting the specialty and title.
There are three kinds of business scope below, the specialty will be more strict.
Enterprises should be set up or equipped with the scale and scope of business, and meet the relevant qualification requirements of quality management, operation and other key positions. Personnel engaged in quality management work should be on duty.
(a) engaged in in vitro diagnostic reagents quality management personnel, there should be a supervisor for the inspector, or with a university degree in testing related disciplines and engaged in testing related work for more than 3 years of work experience. In vitro diagnostic reagents acceptance and after-sales service personnel, should have a secondary school education in laboratory science or related disciplines, or with a junior or above the professional and technical title of inspector.
(B) engaged in implantable and interventional medical devices business personnel should be equipped with medical related college degree or above, and through the production enterprises or suppliers of training personnel.
(C) engaged in corneal contact lenses (contact lenses are also counted), hearing aids and other medical devices with special requirements of the business personnel should be equipped with relevant professional or vocational qualifications.
Expanded:
Apply for Class II medical device business administrative license conditions specific matters
1, the enterprise's legal representative, the person in charge of the enterprise, the quality management personnel should be free of "supervision and management of medical devices regulations" Article 40 of the situation;
2, the enterprise should have within the business with the scale of operation and the scope of operation of the appropriate Quality management organization or full-time quality management personnel; quality management personnel should have nationally recognized relevant professional qualifications or titles, with the qualification of professional and technical personnel according to law. Such as quality management personnel should be on duty, shall not be part-time in other units
3, with the scale and scope of operation of relatively independent business premises.
4, with the scale and scope of operation of the storage conditions (storage equipment, facilities).
5, with the operating products for technical training, after-sales service capabilities.
6, should be in accordance with relevant national and local regulations, establish and improve the necessary quality management system, and strictly enforced.
7, should collect and save the national standards for medical devices, industry standards and supervision and management of medical devices, rules and regulations and special provisions.
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