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How to use RamaXL, including system availability, running reports and how to subscribe.
There are different regulations which apply to devices and equipment including hand gels and PPE (personal protective equipment)
MHRA has published guidance on the importance of applying human factors to medical devices, so they are designed and optimised to minimise patient and user safety risks.
The different types of tests and testing kits for COVID-19, and the specifications for manufacturers.
Current listing of UK brokers authorised to broker human medicines, including company name, registration and address.
An overview of the legal requirements for children’s medicines that Marketing Authorisation Holders (MAHs) need to abide by.
Use the rolling review route when you want to submit your eCTD dossier in separate parts for pre-assessment instead of making a full consolidated document submission.
Information about the MHRA's Graduate Scheme and how to apply.
Directory of current ICH Guidelines which have been implemented by the Medicines and Healthcare products Regulatory Agency.
Guidance on whether or not your product is a medical device.
Information for manufacturers of Software as a Medical Device, detailing events that may cause indirect harm and are therefore reportable.
Approved countries for batch testing and importation of medicines
This guidance sets out how the MHRA is handling centralised applications that were still pending on 1 January 2021.
Some of the different symbols used on medical devices.
This guide has been provided to reduce the burden when preparing responses to Post Inspection Letters.
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 (…
Guidance on the submission, processing and assessment of all completed paediatric studies sponsored by Marketing Authorisation Holders (MAHs)
Guidance for dispensing of valproate-containing medicines in the manufacturer’s original full pack, following amendments to the Human Medicines Regulations (HMRs).
Guidance for safe use in medical, surgical, dental and aesthetic practices
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