Small optical store for class III medical device license, what conditions are required, how to apply for.

According to the latest revision of the 2018 version of the Medical Device Classification Catalog, protective eyewear and other items belong to Class II medical devices, and the operation requires a Class II medical device filing license. Contact contact lenses and care solutions belong to Class III medical devices, the operation of related products need Class III medical device business license. Then, from the current point of view of our contact with the many eyeglasses business, the vast majority of the classification of this catalog is very strange, only a small part of a slight understanding, today to share the optical store how to apply for a medical device license.

1, clear for the three types of medical equipment business license legal subject must be a company, many stores are self-employed business license, so the first need to register a company, a natural person sole proprietorship or joint venture can be, as long as the main body is a limited company on the line.

2, with three types of medical equipment business must be required, the site is greater than 40 square meters, a professional visionary, quality of the person in charge, there are some necessary equipment such as slit lamp, corneal curvature meter (can be leased)

3, there are standardized rules and regulations of management system, inventory management system, etc., you must use the medical equipment sales management software.

After the above conditions are in place, you can apply for a Class III medical device license in the local Food and Drug Administration, in practice, the electronic materials through the audit, there will be a business personnel door-to-door inspection, the process, the details of a good job is the key, especially the site, the warehouse and other environments to be in place. According to our experience, generally the first door-to-door verification will not pass, the staff will put forward corrective comments, this time to fully cooperate, or be rejected on the spot, basically the three types of medical equipment business license is very difficult to handle. We have contacted a merchant was asked to rectify up to 6 times, and finally had no choice but to find us to help complete the on-site review and acceptance. Therefore, the submission of materials is only the first step, on-site verification is the most important, here you have to pay attention to the merchants, but also welcome everyone to leave a message to exchange

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