Mhra application form 2025

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The document outlines the registration process for medical devices in the UK under the Medical Devices Regulations 2002. It includes a detailed RG2 registration form that requires information about the manufacturer, device details, payment methods, and compliance with regulatory standards. The form must be completed accurately by an authorized representative or manufacturer, and it emphasizes the importance of providing necessary documentation and payment to ensure timely processing of registrations.

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Versions	Form popularity	Fillable & printable
2015	4.8 Satisfied (282 Votes)
2013	4 Satisfied (38 Votes)

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We have answers to the most popular questions from our customers. If you can't find an answer to your question, please contact us.

What needs MHRA approval?

If your research project is: a Clinical Trial of an Investigational Medicinal Product (CTIMP) (with the exception of Phase 1 trials in healthy volunteers taking place outside the NHS) a Clinical Investigation or other study of a Medical Device.

What is the turnaround time for MHRA?

new applications typically take 90 working days to process. variations where no inspection is required: 30 working days - variations where an inspection is required: 90 working days.

What is the MHRA equivalent in the US?

Food Drug Administration ing to USA-92, the FDA is responsible for protecting public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices.

What is the timeline for MHRA approval?

Benefit 1: Fast-track drug approval. Regulatory authorityReview time* EMA 210 days3 (7 months) MHRA (not via IRP) 210 days1(7 months) MHRA IRP Route A 60 days1 (2 months) MHRA IRP Route B 110 days1(34 months)1 more row Nov 17, 2023

How long does the drug approval process take?

Once the application is submitted, the FDA has 6 to 10 months to review the information and decide whether to approve the drug or not.

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What is the MHRA?

The Medicines and Healthcare products Regulatory Agency regulates medicines, medical devices and blood components for transfusion in the UK. MHRA is an executive agency, sponsored by the Department of Health and Social Care. Read more about what we do.

What does it mean to be MHRA approved?

At the end of their review, the MHRA will decide whether to authorise the drug. Once a drug has authorisation, it is licensed or approved. All these terms mean the same thing. Go to more information about the MHRA on the GOV.UK website.