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LICENSING REPRESENTATION FORM Section 1: License Application Details I wish to object to the following application Name of Applicant (if known):Jo TolleyPremises Name and Address:7 High StreetMargatePostcode:CT9

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How to fill out medical device establishment licence

01

Gather all necessary information and documents required for the application process.

02

Complete the application form accurately and thoroughly, providing all requested information.

03

Submit the application form along with any required supporting documents to the appropriate regulatory authority.

04

Pay any applicable fees associated with the licence application.

05

Await review and approval of the application by the regulatory authority.

06

Once approved, adhere to any conditions or regulations outlined in the licence.

Who needs medical device establishment licence?

01

Manufacturers of medical devices

02

Importers of medical devices

03

Distributors of medical devices

04

Repackagers or relabellers of medical devices

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What is medical device establishment licence?

A medical device establishment licence is a license required for any establishment that manufactures, imports, distributes, or sells medical devices in a specific country.

Who is required to file medical device establishment licence?

Any establishment that is involved in the manufacturing, importing, distributing, or selling of medical devices is required to file for a medical device establishment licence.

How to fill out medical device establishment licence?

The medical device establishment licence application process typically involves providing information about the establishment, the types of medical devices being handled, quality control measures, and complying with regulations set by the health authorities.

What is the purpose of medical device establishment licence?

The purpose of a medical device establishment licence is to ensure that establishments handling medical devices comply with regulations, maintain quality standards, and provide safe and effective medical devices to consumers.

What information must be reported on medical device establishment licence?

Information such as establishment details, types of medical devices handled, quality control measures, compliance with regulations, and contact information must be reported on a medical device establishment licence application.

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