The Class III license for medical devices is a national system for the classification and management of medical devices, which is divided into Class I, II and III, of which Class III medical devices are the highest risk products. The Class III license for medical devices is mainly issued by the State Food and Drug Administration to supervise and manage the production, sales and use of medical devices.
Enterprises applying for a Class III medical device license are required to:
1, registered capital
In accordance with relevant state regulations, the registered capital of a Class III medical device business enterprise should be not less than 1 million yuan.
2, premises requirements
The three types of medical devices business enterprise premises should meet the relevant requirements, including Have a building and decoration facilities in line with health and safety standards, to meet the storage of medical devices, sales, maintenance and other business needs; equipped with the necessary facilities and equipment, such as computers, telephones, faxes, etc., and to ensure that the facilities, equipment, safe and reliable; in line with the fire prevention and environmental protection and other relevant requirements.
3, personnel requirements
Enterprises should be assessed and recruited full-time person in charge and full-time management personnel, and equipped with professional and technical personnel and service personnel, of which the full-time management personnel should have professional knowledge of medical devices and related management experience, professional and technical personnel should have medical device-related professional skills, service personnel should be equipped with professional training certificates.
4, material requirements
Enterprises need to submit relevant application materials to the local market supervision bureau, such as industrial and commercial business license, tax registration certificate, organization code certificate, premises lease contract, list of facilities and equipment, personnel files, etc., and to submit the quality system of medical devices documents.
To sum up: for the three types of medical device license need to meet a series of conditions and requirements, including the basic conditions of the enterprise, product-related conditions, personnel-related conditions and other related conditions. Enterprises need to carefully understand and meet these conditions to ensure that they have the appropriate capabilities and qualifications to ensure the quality and safety of their products.
Legal basis:
"Regulations for the Supervision and Administration of Medical Devices"
Article 38
If a person fails to obtain a "Medical Device Business Enterprise License" to operate Class II and Class III medical devices, he/she will be ordered by the drug supervision and management department at or above the county level to stop the operation, confiscate the products illegally operated and the illegal income, and impose a fine of not less than two times and not more than five times the illegal income. The illegal income of more than five times the illegal income of more than two times the following fine; no illegal income or illegal income of less than five thousand yuan, and impose a fine of more than five thousand yuan 20,000 yuan; constitutes a crime, shall be investigated for criminal responsibility.