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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.
How the MHRA makes decisions on what is a medicinal product (borderline products).
How to begin with evaluating a digital health product, including when to evaluate, budgeting and getting support.
How to create a model of how your digital health product works and choose measures for your evaluation.
Information and guidance on a range of medical devices for users and patients.
Resources to help anyone developing or running a digital health product to conduct an evaluation.
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 .
A new pathway supporting innovative approaches to the safe, timely and efficient development of medicines to improve patient access.
Get help to classify herbal medicines, vitamins, food preparations, supplements and tonics for import and export.
Information for manufacturers of medical devices about reporting adverse incidents and field safety corrective actions to the MHRA.
Why it's important to evaluate digital health products that have been developed rapidly and how to choose evaluation methods in these circumstances.
This research included interviews in 2013–14 with 17 manufacturers and distributors
What you need to know before you can place a medical device on the Great Britain market with a UKCA mark.
Search for information about medicines including patient information leaflets (PILs), details on how the medicine can be used (SmPCs) and scientific reports (PARs).
How to apply for a clinical trial including eligibility, phases, model IMPDs, costs and how to make changes to your application.
How to get scientific advice about your licence application from MHRA, including: submitting a request, your meeting with MHRA, fees.
Guidance for industry on flexible approaches to regulation we are taking during the COVID-19 outbreak.
How to account for VAT on goods and services provided by registered health professionals, including doctors, dentists, nurses and pharmacists.
Competent authorities of exporting countries should use the relevant model health certificate as a template to create a version exporters can apply for to export other animal by-products to Great Britain, the Channel Islands or Isle of Man.
Competent authorities of exporting countries should use the relevant model health certificate as a template to create a version exporters can apply for to export other animal products to Great Britain, the Channel Islands or Isle of Man.
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