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How to get approval |
Guidance to ApplicantsThese documents are available in Adobe Acrobat format for downloading. The Adobe® Acrobat Reader® can be freely downloaded. Viewers with visual difficulties may find it useful to investigate services provided to improve the accessibility of Acrobat documents - http://access.adobe.com 1. IntroductionThe document "How do I apply for approval of my
product(s)?" outlines the essential elements of the approval application process.
You are strongly recommended to read this before proceeding further with your
application. 2. Advice SheetsAdvice Sheet 1 gives an overview of the regulatory requirements and explains how to make an application for approval. Advice sheet 2 gives guidance on what will be required in your Instructions for Use document - it is very important that any IFU submitted to us conforms fully with these requirements, otherwise your applications may be delayed. The remaining sheets provide information on the application requirements for certain product types. In addition, a range of Application forms are available, please see section 3 below. 55 Whitehall, London, SW1A 2EY
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website is set out in an accessible and understandable manner. |