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How a manufacturer can apply for approval to supply a non-compliant medical device on humanitarian grounds.
List of manufacturers and their medical devices which have been granted an exemption by the MHRA. The list also includes manufacturers whose exemption expired or was cancelled. This information will be listed for 2 months after expiry or cancellation.
The government’s plan to support a thriving UK medtech sector and make sure the health and care system can reliably access safe, effective and innovative medical technologies to deliver the best outcomes for patients.
This reciprocal healthcare policy outlines the factors the Secretary of State will consider when making funding decisions for care abroad where exceptional circumstances may apply.
How to pay an NHS debt so it does not affect your visa application or entry to the UK.
How to package medicines for sale and what information you must provide to consumers and healthcare professionals.
If you’re travelling abroad, it's important to take out appropriate travel insurance before you go.
The Medicines and Healthcare products Regulatory Agency (MHRA) have embarked upon an ambitious programme of reform to ensure that medical device regulation is fit for purpose for software, including artificial intelligence (AI).
The requirements for 3D printed products will depend on whether they are classed as medical devices, personal protective equipment (PPE) or both.
Advice on writing clear notices and maximising replies to your FSNs.
Information that patients are entitled to under the Data Protection Act 2018 and the General Data Protection Regulation 2016/279.
How to get fast-track approval of medical devices during COVID-19.
An overview of the process including submitting or fast tracking an application, naming your medicine and paying fees.
Case study from Best Practice AI.
This guidance demonstrates stakeholders, including the government, working together to address supply issues.
The CMA has completed its remittal into the private healthcare market and has brought article 22 of the 2014 Order into force.
Information for manufacturers of medical devices about reporting adverse incidents and field safety corrective actions to the MHRA.
How to conform with the legal requirements for placing medical devices on the market.
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