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
If the UKCA marking applies to products you manufacture or supply, you will have specific obligations and responsibilities for compliance, depending on your role.
Apply to become or identify an approved manufacturer authorised to carry out conformity assessment.
Comply with good manufacturing practice (GMP) and good distribution practice (GDP), and prepare for an inspection.
Guidance on applications and licences for manufacturers & wholesalers, suspended and revoked licences, registrations, exporting medicines, defective medicinal products and fees.
How to ensure the products you make or import comply with the law and are safe for consumers to use.
How to write clear and effective field safety notices (FSNs) for medical devices.
Information on the new regulations for decentralised manufacture, including point of care and modular manufacture, which come into effect 23 July 2025.
A digital platform designed to facilitate the reporting, monitoring, and management of medical device incidents.
Information for manufacturers of medical devices on post-market surveillance, reporting adverse incidents and field safety corrective actions to the MHRA.
UK guideline on GMP for decentralised manufacturing, ensuring compliance with EU GMP principles for safe, quality medicinal products.
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. Please fill in this survey (opens in a new tab and requires JavaScript).