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How to join the phase I accreditation scheme.
Guidance for health institutions that manufacture general medical devices under the Health Institution Exemption (HIE).
Take care when using creams to treat dry skin conditions as they can easily dry onto clothing, bedding and bandages, making them more flammable.
How the MHRA makes decisions on whether a borderline product is a medical device and which risk class should apply.
How manufacturers should undertake a clinical investigation for a medical device to ensure they comply with medical device regulations.
Guidance on the safe and effective use of GLP-1 medicines for weight loss and diabetes.
Guidance for UK wholesalers and manufacturers on how to import human medicines including unlicensed medicines, how to apply for a licence and how much it costs.
How to write clear and effective field safety notices (FSNs) for medical devices.
The Vaccine Development Evaluation Centre (VDEC) at Porton Down in Wiltshire facilitates the development and evaluation of new vaccines and therapeutics.
Reporting, investigating and recalling suspected defective medicinal products to the Defective Medicines Report Centre (DMRC).
What you need to do before your product can be placed on the Great Britain market with a UKCA mark.
How to comply with the requirements on promoting medicines to the public and to prescribers and suppliers of medicines
Information for healthcare professionals on how pulse oximeters are regulated, home use and issues to look out for when using the devices
Guidance for Applicants wishing to apply for a Promising Innovative Medicines designation, pre-submission meeting or an EAMS Scientific Opinion.
The MHRA will review applications for orphan designation at the time of a marketing authorisation (MA) or variation application.
How to submit your periodic safety update report report (PSUR) or periodic benefit risk evaluation report (PBRER)
Information about ensuring blood and blood component safety.
How to apply for a regulatory advice meeting on medical devices and in vitro diagnostic devices.
The Medicines and Healthcare Regulatory Agency have launched RegulatoryConnect, a service that provides the capability to track applications and view live authorisation details.
Patient factsheet providing information on respiratory syncytial virus (RSV) and RSV vaccination.
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