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Apply to become or identify an approved manufacturer authorised to carry out conformity assessment.
Information for manufacturers of medical devices on post-market surveillance, reporting adverse incidents and field safety corrective actions to the MHRA.
How to ensure the products you make or import comply with the law and are safe for consumers to use.
Guidance on applications and licences for manufacturers & wholesalers, suspended and revoked licences, registrations, exporting medicines, defective medicinal products and fees.
Guidance for manufacturers, importers and distributors.
Comply with good manufacturing practice (GMP) and good distribution practice (GDP), and prepare for an inspection.
If the UKCA marking applies to products you manufacture or supply, you will have specific obligations and responsibilities for compliance, depending on your role.
How to write clear and effective field safety notices (FSNs) for medical devices.
How to apply for an authorisation to manufacture authorised veterinary medicines or medicines marketed under the Exemptions for small pet animals.
What you need to know about and do to comply with the law and keep consumers safe.
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