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Regulating medical devices in the UK - GOV.UK
- https://www.gov.uk/guidance/regulating-medical-devices-in-the-uk
Factsheet: medical devices overview - GOV.UK
- https://www.gov.uk/government/publications/medicines-and-medical-devices-bill-overarching-documents/factsheet-medical-devices-overview
- Regulations on medical devices Medical devices in the UK are regulated by the Medical Devices Regulations 2002 (as amended) which provides for a system of medical device...
Register medical devices to place on the market - GOV.UK
- https://www.gov.uk/guidance/register-medical-devices-to-place-on-the-market
- Global Medical Devices Nomenclature ( GMDN) code and term to describe your device Basic UDI-DI (if applicable) medical device name (brand/trade/proprietary …
Medical devices: how to comply with the legal …
- https://www.gov.uk/guidance/medical-devices-how-to-comply-with-the-legal-requirements
- According to the Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002), a medical device is described as any instrument, apparatus, …
Medical devices: information for users and patients
- https://www.gov.uk/guidance/medical-devices-information-for-users-and-patients
- Medical devices must have CE marking, UKCA marking or CE UKNI marking by law. This mark means that, provided you use it correctly, the device will work …
Medicines, medical devices and blood regulation and …
- https://www.gov.uk/topic/medicines-medical-devices-blood/marketing-authorisations-variations-licensing
- Medicines: licensing time-based performance measures Marketing authorisations: lists of granted licences Parallel import licences: lists of approved products Payment, fees and …
Apply for manufacturer or wholesaler of medicines …
- https://www.gov.uk/guidance/apply-for-manufacturer-or-wholesaler-of-medicines-licences
- you are applying for a wholesaler licence to sell GSL medicines only you are a registered pharmacy and the wholesale of medicines amounts to less than 15% of your …
United Kingdom - UK Medical Device Registration
- https://arazygroup.com/medical-device-registration-united-kingdom/
- Last updated on January 6th, 2022. Medical Device Regulations and Classification in United Kingdom REGULATORY AUTHORITY: Medical devices in the …
United Kingdom Medical Device Regulation
- https://www.trade.gov/market-intelligence/united-kingdom-medical-device-regulation
- UK regulatory body, the Medicines and Healthcare products Regulatory Agency (MHRA), has issued guidance relating to the regulation of medical devices and …
Licensing: how to apply - GOV.UK
- https://www.gov.uk/government/collections/licencing-how-to-apply
- Apply for a licence to market a medicine in the UK 25 January 2021 Guidance Register to make submissions to the MHRA 4 May 2021 Guidance Types of …
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