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|Acting as a medical device agent|
|Author: Anonymous Medical Devices: Site author Hits: Updated: 2019-12-24|
Have college degree or above, familiar with medical device related laws and regulations. 2. Personnel requirements: The person who operates a medical device company should be the one. The quality inspector cannot be a part-time employee in another sentry box, and the company is also a person in charge of quality management.
, Dustproof, insect-proof, moisture-proof, rodent-proof, pollution-proof, fire safety, detection and temperature and humidity conditioning equipment and equipment, and lighting equipment to meet the requirements of the warehouse requirements of the non-residential area of not less than 20 square meters for departmental product requirements of 100 More than square meters and require light and ventilation.
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Qualified personnel with a minimum of one year of work experience must have a college degree. Bachelor degree or above in clinical medicine or a title of attending physician or more must be possessed by those holding the second-class medical device production quality.
46, 6877, operating medical electronic devices Ш6821, 6822, 6823 For three types of medical device products, such as operating implantable devices three types 6821, 6822, 68,
Four copies of the applicant's qualification certificate copy of the post-approval notice of the name of the medical device operating company I. Requirements for operating medical device documents: "Medical Device Operating Enterprise Permit / Permissible Application Form" 1.
A full-time quality inspector One who is a technical secondary school or above major in the field of inspection and acceptance, a post-sale staff warehouse custody inspector requires one to be a person or member of the quality of the job history for more than three years for the disposal and inspection of the college level or above.
Identify clearly and implement the classified classification for bidding according to the product batch storage. The public storage area such as the delivery area, the failed product area, etc. shall be divided into the inspection area, the qualified product area, and the like.
Companies need two or more shareholders to register a medical device operating company. 7 legal representatives except company personnel are required at most. People, full-time quality inspectors, accountants, salespersons, warehouse clerks and other enterprises serve as people, supervisors, or part of the manager, quality.
Hello, please start the whole process. If you need to prepare, there are a lot of prerequisites. At this moment, you need to be a medical device agent. The materials found are below for me. You are willing to help
70 quality managers need relevant professional majors with a bachelor degree or above with more than 2 years of work experience or intermediate or higher professional titles 6815, 6863, 6864, 6665, 6866, and operation software 68.
The requirements for the office space of a device company are the non-residential area. Section III. The requirements for offices and warehouses: operating medical care. Reagent utilization area below 60 square meters is not.
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