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Information for manufacturers of medical devices about reporting adverse incidents and field safety corrective actions to the MHRA.
How a product complies with EU safety, health and environmental requirements, and how to place a CE marking on your product.
What you need to do to place a medical device on the Great Britain, Northern Ireland and European Union (EU) markets.
How to register your medical devices with the Medicines and Healthcare products Regulatory Agency (MHRA) for the markets in Great Britain and Northern Ireland
Comply with good manufacturing practice (GMP) and good distribution practice (GDP), and prepare for an inspection.
What you need to know about and do to comply with the law and keep consumers safe.
How to ensure the products you make or import comply with the law and are safe for consumers to use.
If the UKCA marking applies to products you manufacture or supply, you will have specific obligations and responsibilities for compliance, depending on your role.
Find out which gas appliances must comply with the Gas Appliances (Safety) Regulations 1995, exemption and penalties for non-compliance
How to notify the MHRA of your intention to carry out a clinical investigation for medical devices.
How to register your chargepoints for OZEV chargepoint grant schemes as a manufacturer.
How to make sure that your products are properly checked for conformity and your technical documents are managed correctly.
Advice on writing clear notices and maximising replies to your FSNs.
Guidance for manufacturers, importers and distributors.
How to apply for, update and cancel licences for the manufacture, import and wholesale of human and veterinary medicines.
Change your protocol, update your authorisation, report safety issues, submit safety updates and complete your end-of-trial study report.
ISSUES UNDER THE EUROPEAN PUBLIC LIMITED-LIABILITY COMPANY (EMPLOYEE INVOLVEMENT) REGULATIONS ON WHICH APPLICATIONS OR COMPLAINTS CAN BE MADE TO THE CAC
Sets out key principles in understanding viability in plan making and decision taking.
What you need to do to comply with regulations on manufactured products you place on the market in Great Britain.
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