Devices made by Silimed
IntroductionThe CE certificate for all medical devices made by Silimed was suspended in 2015 by the notified body after particles were found on their surface.We issued a medical device alert…
Chapter 8 – labelling guidance – Great Britain
Clarification of the UK Government’s interpretation of the requirements for labelling e-liquids for Great Britain.
Chapter 4 – nicotine dose guidance – Great Britain
Information on testing and reporting levels of nicotine uptake when submitting a notification of intent to market e-cigarette and vape products in Great Britain.
Guidance on applying human factors to medical devices
This guidance is primarily aimed at manufacturers of all device classes and developers of medical devices and drug-device combination products, and UK Approved Bodies responsible for assuring the quality of…
List of approved countries for authorised human medicines
The Human Medicines Regulations 2012 refers to lists of approved countries for:Importation of medicines under a wholesale dealer’s licenceBatch testing of medicinesManufacturing of active substances with regulatory standards equivalent to the…
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