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A new pathway supporting innovative approaches to the safe, timely and efficient development of medicines to improve patient access.
How to apply for a clinical trial including eligibility, phases, model IMPDs, costs and how to make changes to your application.
What animal by-products (ABPs) are, how to set up a site that uses them safely, the paperwork you need, and how to dispose of them.
There are different regulations which apply to devices and equipment including hand gels and PPE (personal protective equipment)
How to account for VAT on goods and services provided by registered health professionals, including doctors, dentists, nurses and pharmacists.
Resources to help anyone developing or running a digital health product to conduct an evaluation.
How to use a cost benefit analysis to evaluate your digital health product.
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.
Information and guidance on a range of medical devices for users and patients.
Industry review identifying opportunities for development of financial products to help people pay for care.
How to get scientific advice about your licence application from MHRA, including: submitting a request, your meeting with MHRA, fees.
How a product complies with EU safety, health and environmental requirements, and how to place a CE marking on your product.
Things to consider when buying and using products.
Guidance for industry on flexible approaches to regulation we are taking during the COVID-19 outbreak.
How to use a cost effectiveness analysis to evaluate your digital health product.
Details of the Yellow Card scheme, which is the system for recording adverse incidents with medicines and medical devices in the UK.
How to use an ethnographic study to evaluate your digital health product.
Information for manufacturers of medical devices about reporting adverse incidents and field safety corrective actions to the MHRA.
How to begin with evaluating a digital health product, including when to evaluate, budgeting and getting support.
The Medicines and Healthcare products Regulatory Agency regulates medicines, medical devices and blood components for transfusion in the UK. MHRA is an executive agency, sponsored by the Department of Health and Social Care .
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