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Information for manufacturers of medical devices on post-market surveillance, reporting adverse incidents and field safety corrective actions to the MHRA.
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.
How to ensure the products you make or import comply with the law and are safe for consumers to use.
What you need to know about and do to comply with the law and keep consumers safe.
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 notify the MHRA of your intention to carry out a clinical investigation for medical devices.
How to write clear and effective field safety notices (FSNs) for medical devices.
Guidance for manufacturers, importers and distributors.
How to make sure that your products are properly checked for conformity and your technical documents are managed correctly.
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