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|What are the general conditions for a medical device distributor to be a bad boy?|
|Author: Anonymous Medical Devices: Site author Hits: Updated: 2019-12-24|
, 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.
6840, 6845, 6854, 6858, operating medical and sanitary materials and dressing consumables 6815, 6863, 6864, 6665, 6866, operating software Ш 6870 Quality managers need relevant professional bachelor degree or above with 2 years of work experience or intermediate or higher title For the three types of medical device products, for example, operating implantable devices such as 6821, 6822, 6846, and 6877, operating medical electronic devices such as 6821, 6822, 6823, 6824, 6825, 6826, 6828, 6830, 6832, 6832, and 6833.
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.
In addition, the enterprise should have the ability to adapt to the technical training and after-sales service of the medical device products it operates or agree to be provided by a third party to provide technical support. 4. The requirements of the sanitary management system and the after-sales service system: Operating medical device companies should be set up perfectly. Sanitary management guarantees the safety of products. What's the reply? Comments received like it has been disliked
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.
The medical device operation license of the company has launched all the RBI response categories, and the system and procedures have met the requirements of warehouse, personnel and quality. What's the reply? Comments received like it has been disliked
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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.
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.
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.
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.
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.
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