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How to notify the MHRA of your intention to carry out a clinical investigation for medical devices.
Directory of current ICH Guidelines which have been implemented by the Medicines and Healthcare products Regulatory Agency.
A summary of the types of scientific advice available at the MHRA, the process for getting advice and the fees involved.
Advice for manufacturers of Class I medical devices for placing products on the UK market
Information about medical devices that the public can buy for personal use and how we make sure they are safe and effective.
Change your protocol, update your authorisation, report safety issues, submit safety updates and complete your end-of-trial study report.
How to write clear and effective field safety notices (FSNs) for medical devices.
Information for manufacturers of medical devices on post-market surveillance, reporting adverse incidents and field safety corrective actions to the MHRA.
Comply with good manufacturing practice (GMP) and good distribution practice (GDP), and prepare for an inspection.
Guidance on how to license electronic cigarettes and other inhaled nicotine-containing products (NCPs) as medicines in the UK.
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