The state has implemented the classification and management of medical devices according to the degree of risk, which is specifically divided into Class I, Class II and Class III. According to the latest release of the State Food and Drug Administration "supervision and management of medical devices", the operation of the first class of medical devices do not need to be licensed and filed, the operation of the second class of medical devices to implement the record management, the operation of the third class of medical devices to implement the management of the license. If the enterprise also needs to engage in medical device network sales, it must also comply with the State Food and Drug Administration issued on the "supervision and management of medical device network sales approach".
What types of enterprises need to apply?
Every enterprise that wants to legally engage in the operation of medical devices within the territory of the People's Republic of China*** and the State must apply for and have the qualification. The operation of Class I medical devices do not require licensing and filing, the operation of Class II medical devices for the record management, the operation of Class III medical devices for licensing management.
How to apply for a medical device license:
Enterprises need to have the latest release of the State Food and Drug Administration of the "supervision and management of medical devices business approach" in the enterprise conditions before applying.
Par1 Project Introduction
Medical equipment business license is a medical device business enterprises must have the documents to start the first class of medical equipment business enterprises should be to the provinces, autonomous regions and municipalities directly under the Central People's Government of the drug supervision and management department for the record; the opening of the second class, the third class of medical equipment business enterprises should be by the provinces, autonomous regions and municipalities directly under the Central People's Government of the drug supervision and management departments Review and approval, and issued "medical device business license". No "medical equipment business enterprise license" of the administration for industry and commerce shall not be issued business license.
Medical device license certification scope:
Medical device license is a medical device business enterprises must have the documents to start the first, second, third class medical device business enterprises, are required to apply for this qualification.
Par2 apply for the first class of medical devices business enterprise filing procedures and material requirements:
Enterprises operating in the first class of medical devices must apply for the filing of seal procedures. Filing procedures and reporting materials:
One, business (including part-time) enterprises to apply, fill out the "medical device business enterprise filing form" a type of three (copies are invalid), signed by the legal representative and the enterprise seal;
Two, provide materials
1, business name industrial and commercial preregistration certificate or a copy of the industrial and commercial business license copy of 1;
2, a copy of the title certificate or certificate of graduation of technical personnel;
3, all varieties of medical devices operated by a copy of the product registration certificate;
4, the basic situation of the enterprise materials (fill in the filing form), including: the economic nature of the enterprise, the scope of business operations, the variety of medical devices, technical personnel, medical equipment, quality assurance and after-sales service measures, etc.;
Third, the enterprise declaration materials must be true, all materials uniformly with A4 specification paper, fill in the form of neat font, with standardized simplified Chinese characters, all the declaration materials should be stamped with the official seal of the enterprise.
Four, complete information before acceptance, acceptance of 30 working days for the record seal.