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 intermediate or above 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 count), hearing aids and other medical devices with special requirements of the business personnel should be equipped with relevant professional or vocational qualifications.
Expanded
Legal responsibility
1, the applicant to conceal the relevant information or provide false materials to apply for a "medical device license", the province, autonomous region, municipality directly under the Central (food) drug supervision and management department or accept the entrusted municipal (food) drug supervision and management bodies on the application of Not admissible or not issued "medical device business license", and give a warning. The applicant shall not apply again within one year, "Medical Device Business License".
2, the applicant by deception, bribery and other improper means to obtain a "medical device business enterprise license", (food) drug supervision and management authorities shall revoke its "medical device business enterprise license", and give a warning, and impose a fine of 10,000 yuan or more than 20,000 yuan. The applicant shall not apply again for the "Medical Device Business Enterprise License" within 3 years.
Baidu Encyclopedia-Medical Device Business License