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Apply to become or identify an approved manufacturer authorised to carry out conformity assessment.
If the UKCA marking applies to products you manufacture or supply, you will have specific obligations and responsibilities for compliance, depending on your role.
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.
MHRA’s mechanism for evaluating the justifications supplied by applicant organisations who plan to utilise decentralised manufacture.
How to write clear and effective field safety notices (FSNs) for medical devices.
UK guideline on GMP for decentralised manufacturing, ensuring compliance with EU GMP principles for safe, quality medicinal products.
Information on the new regulations for decentralised manufacture, including point of care and modular manufacture, which come into effect 23 July 2025.
Information for manufacturers of medical devices on post-market surveillance, reporting adverse incidents and field safety corrective actions to the MHRA.
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