Any enterprise engaged in contact lens fitting must obtain a Medical Device Business License issued by the drug administration department, and enterprises and individuals without a license will not be allowed to engage in contact lens fitting.
The State Food Supervision Administration (SFSA) classified contact lenses and nursing fluids as Class III medical devices in 2002 and implemented a license management system. Contact lens dispensers applying for a Medical Device License are required to meet the following entry requirements: they must have a full-time optometrist; they must be equipped with professional equipment such as corneal curvature meters and slit lamps; they must have an independent contact lens dispensing area; and they must have established a comprehensive system of records for the purchase, acceptance, and sale of medical devices.
Apply for a medical device license
I, the materials to be prepared
Business license, identity of the person in charge of the enterprise, the person in charge of the quality of the identity card and academic certificate, real estate property contract, business premises and warehouse premises floor plan, etc.
Two, for the process
1, the collection of information, including a copy of the business license, a copy of the academic degree, Copy of ID card, copy of real estate license, etc.
2, do the information including floor plan, facilities and equipment catalog, power of attorney, application form, management system catalog, authenticity of the statement and so on.
3, login, pre-declaration, window to submit information, in line with the submission, you can immediately handle to get the license. Three types of licenses for the more information required, the site acceptance is more stringent