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How to register your medical devices with the Medicines and Healthcare products Regulatory Agency (MHRA) for the markets in Great Britain and Northern Ireland
Guidance on what approved bodies are, what they do and how you can become one.
What you need to know before you can place a medical device on the Great Britain market with a UKCA mark.
Information about the EU Regulations and their implementation in Northern Ireland
How the MHRA makes decisions on when a product is a medical device (borderline products), and which risk class should apply to a medical device.
What you need to do to place a medical device on the Great Britain, Northern Ireland and European Union (EU) markets.
How to conform with the legal requirements for placing medical devices on the market.
Information and guidance on a range of medical devices for users and patients.
Information for manufacturers of medical devices about reporting adverse incidents and field safety corrective actions to the MHRA.
List of manufacturers and their medical devices granted an exemption by MHRA. The list also includes manufacturers whose exemption expired or was cancelled.
Guidance for UK wholesalers and manufacturers on how to import human medicines including unlicensed medicines, how to apply for a licence and how much it costs.
How a manufacturer can apply for approval to supply a non-compliant medical device on humanitarian grounds.
A wholesale dealer in Great Britain may import Qualified Person certified medicines from the European Economic Area if certain checks are made by the ‘Responsible Person (import)’
How the MHRA makes decisions on what is a medicinal product (borderline products).
Placing a veterinary medicine on the market, including non-medicinal products, medicinal words and phrases, how to obtain advice, report non-compliance.
Guidance on how to license electronic cigarettes and other inhaled nicotine-containing products (NCPs) as medicines in the UK.
Guidance for NHS regarding disclosure to individuals holding either a Lasting Power of Attorney or a deputyship.
How to get an ENG1 or ML5 medical certificate.
How to apply for a clinical trial including eligibility, phases, model IMPDs, costs and how to make changes to your application.
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