New Distributor Sign-Up - Biocare Medical

Company Profile

How long has your company been distributing medical device?*

Number of Employees:*

Number of Year(s) in Business:*

Business Compatibility

Does your company have experience with medical device manufactures?*

Yes
No

Quality

Is your company registered with the local regulatory authority?*

Yes
No

If Yes, please provide name of local authority and a copy the registration.

Copy of the Registration

Accepted file types: pdf, jpeg, png, gif, Max. file size: 8 MB.

If No, please explain.

Does your company ensure manufacturer’s product labeling meets applicable regulatory requirements per local laws, regulations, and standards prior to distrubtuion?*

Yes
No

If No, please explain.

Does your company have personnel with the knowledge of local regulatory requirements for the distribution of medical devices?*

Yes
No

If Yes, please provide the standard/regulation name and number that you are in compliance with.:

If No, please explain.

Does your company perform all required applicable local registrations for the products you put on the market?*

Yes
No

If No, please explain.

Does your company generate and maintain any installation and servicing activities for the products you put on the market?*

Yes
No

If No, please explain.

Does your company conduct any user training?*

Yes
No

Does your company maintain traceability of distributed products (at a minimum the lifetime of the product)?*

Yes
No

Does your company have a location designated for nonconforming products*

Yes
No

If No, please explain.

Does your company have any experience in representing manufacturer when conducting recalls, including notification to the appropriate regulatory authority?*

Yes
No

Contact Information

Contact Name*

First Last

Phone*

Email

Fax

New Distributor Form

Company Information

Company Profile

Business Compatibility

Quality

Contact Information

New Distributor Form

Company Information

Company Profile

Business Compatibility

Quality

Contact Information

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