by Stuart McCully | 26 Jun, 2019 | Medical Devices
Substances used for in vitro diagnosis, medical device, mechanical contraceptives, disinfectants and insecticides and other notified devices in India are now regulated by the Medical Device Rules, 2017, which became effective from January 1, 2018. Prior to the...
by chuck_ltd | 6 Jul, 2017 | CHCUK News & Articles, Medical Apps, Medical Devices, News
Source: Osborne Clarke It is widely known that in some circumstances, software may fall within the category of medical device and so have to comply with the associated regulations as regards its marketing. But deciding exactly when software will be categorised as...
by chuck_ltd | 9 Jan, 2017 | CHCUK News & Articles, Cybersecurity, Digital Health Technology, Medical Apps, Medical Devices, News
On 28 December 2016, the Food and Drug Administration (FDA) issued guidance to inform industry and FDA staff of the Agency’s recommendations for managing postmarket cybersecurity vulnerabilities for marketed and distributed medical devices. In addition to the specific...
by chuck_ltd | 6 Jan, 2017 | Medical Devices
On December 30, 2016, the Food and Drug Administration (FDA or the Agency) issued a final guidance document entitled Medical Device Accessories – Describing Accessories and Classification Pathways for New Accessory Types. This guidance generally affirms the framework...
by chuck_ltd | 31 Aug, 2016 | CHCUK News & Articles, Medical Apps, Medical Devices, News, Real Word Evidence
Updated guidance issued to help identify the health apps which are medical devices and make sure they comply with regulations and are acceptably safe. From counting steps to helping healthcare professionals prescribe treatment for burns injuries, healthcare apps and...
by chuck_ltd | 8 Aug, 2016 | CHCUK News & Articles, Medical Devices, News, Real Word Evidence
FDA has issued a draft guidance to clarify how they evaluate real-world data to determine whether it may be sufficiently relevant and reliable to generate the types of real-world evidence that can be used in FDA regulatory decision-making for medical devices....
by chuck_ltd | 27 May, 2016 | CHCUK News & Articles, Medical Devices
On Wednesday 25 May the EU institutions reached agreement on the draft texts for the revised Medical Devices Regulation and In Vitro Diagnostics Regulation, which will together replace the existing three Directives regulating devices, active implantable devices and in...
