We use some essential cookies to make this website work.
We’d like to set additional cookies to understand how you use GOV.UK, remember your settings and improve government services.
We also use cookies set by other sites to help us deliver content from their services.
You have accepted additional cookies. You can change your cookie settings at any time.
You have rejected additional cookies. You can change your cookie settings at any time.
Departments, agencies and public bodies
News stories, speeches, letters and notices
Detailed guidance, regulations and rules
Reports, analysis and official statistics
Consultations and strategy
Data, Freedom of Information releases and corporate reports
The official UK government website for data and insights on COVID-19.
How to register your medical devices with the Medicines and Healthcare products Regulatory Agency (MHRA) for the markets in Great Britain and Northern Ireland
How to conform with the legal requirements for placing medical devices on the market.
The requirements for 3D printed products will depend on whether they are classed as medical devices, personal protective equipment (PPE) or both.
Directory of current ICH Guidelines which have been implemented by the Medicines and Healthcare products Regulatory Agency.
Advice on writing clear notices and maximising replies to your FSNs.
The Foreign, Commonwealth & Development Office (FCDO) provides lists of English-speaking lawyers abroad to help British nationals find the legal support they need.
Comply with good manufacturing practice (GMP) and good distribution practice (GDP), and prepare for an inspection.
How to use a case-control study to evaluate your digital health product.
Form D20: Medical examination statement of parties and examiner.
The epidemiology, symptoms, diagnosis and management of human T-cell lymphotropic virus types 1 and 2 (HTLV-1 and HTLV-2).
Guidance for people with symptoms of a respiratory infection including COVID-19, or a positive test result for COVID-19.
Advice and guidance on the health needs of migrant patients for healthcare practitioners.
What you need to know before you can place a medical device on the Great Britain market with a UKCA mark.
Submissions related to human medicines need to be submitted directly to the MHRA.
Apply for a higher education course, track your application and accept or reject your offers.
Find registered patents, patent applications and pending patents
Apply for changes to your marketing authorisation, including minor variations type IA and IB, major variations type II and extensions.
How to use a randomised controlled trial to evaluate your digital health product.
Don’t include personal or financial information like your National Insurance number or credit card details.
To help us improve GOV.UK, we’d like to know more about your visit today. We’ll send you a link to a feedback form. It will take only 2 minutes to fill in. Don’t worry we won’t send you spam or share your email address with anyone.