Increase the scope of business of Class II medical devices need to apply for what materials

DC Pontchanger Consulting: Currently the implementation of Class II filing business, the subject needs to prepare the personnel site products three major parts of the material, specifically:

One, the personnel

① Copy of ID card

② copy of the academic certificate

③ resume

④ proof of separation (quality personnel and acceptance of staff need to be provided) and fill out the medical device Enterprise practitioners form

⑤ personnel requirements for three people, including the person in charge of quality (1) bachelor's degree or higher, quality staff (2) secondary school or above

Two, the product information

① "Medical Device Registration Certificate" and product registration form and a copy of the accompanying pages

② supplier copy of the business license

③ "" Medical Device Business License "copy Medical Device Business License" copy

④ "Medical Device Manufacturer License" copy

⑤ "Medical Device Manufacturing Accreditation" copy

⑥ Authorization (the supplier authorizes your company to operate the medical device product authorization)

⑦ product promotional color or brochures or product manuals, etc.

Note: The supplier's business license is not required for the medical device business license.

Note: The above copies need to be stamped "supplier" enterprise's official seal, if the supplier is a manufacturer, you need to provide the ④, ⑤.

Three, site materials

① Including property certificates, lease agreements, floor plans, location maps, property information query sheet and other materials.

② Office and warehouse decoration and layout (Type II requires an office area of not less than 30 square meters, warehouse area of not less than 15 square meters)

And then a bunch of small and large forms to fill out

These forms will be used in a variety of ways.