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This guide has been provided to reduce the burden when preparing responses to Post Inspection Letters.
Guidance to help medicine manufacturers meet safe limits on levels of nitrosamine impurities in medicines.
Some of the different symbols used on medical devices.
Information on medical facilities available in Timor-Leste
How to get fast-track approval of medical devices during COVID-19.
Guidance for holders of Marketing Authorisations approved in Northern Ireland or the EU/EEA member states who want to bring a product to market in Great Britain.
A summary of actions related to problems with T34 syringe drivers
Information for manufacturers of Software as a Medical Device, detailing events that may cause indirect harm and are therefore reportable.
Which submission type to select when submitting a notification of intent to market e-cigarette and vape products in Great Britain.
Guidance for medical device manufacturers on when electronic instructions for use can be used.
A flyer to circulate to customers alongside a field safety notice covering what it is and why it's important to take action.
Guidance for manufacturers who don’t design or manufacture devices but place their names on the product.
Under some circumstances (clarified in this statement), the CMA will not prioritise enforcement action against competing drug firms in relation to commercial negotiations to make combination therapies available to patients, …
This report reviews data on patient doses and equipment trends in dental X-ray imaging procedures between 2014 and 2017.
Guidance for marketing authorisation holders on drafting direct healthcare professional communications (DHPCs)
Guidance for healthcare establishments that manufacture medical devices in-house.
The types of emissions a manufacturer or importer of e-cigarettes should notify us about.
Checklists providing a practical guide to using medical devices.
How the ‘Written Confirmation’ process operates for active substances manufactured in Great Britain (England, Wales and Scotland).
How to apply to have nutritional or dermatological products reviewed by the Advisory Committee on Borderline Substances (ACBS).
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