medicines-medical devices-regulatory affairs
TGA, Australia has published guidance on the imminent reclassification of certain medical devices. Which medical devices are going to be reclassified? The following medical devices are going to be reclassified: Medical devices in direct contact with the heart, central circulatory…
Last updated: 4 October 2022 See updates at the end of the post. Swissmedic has provided practical interpretation on the requirement of an authorised representative (CH-REP) for drug-device combination products. Swiss authorised representative (CH-REP) The revision of the Medical Devices…
The UK MHRA is updating regulations applying to software and artificial intelligence (AI) as a medical device. The exciting and fast developing field of software and artificial intelligence (AI) as a medical device has an increasingly prominent role within health…
The UK MHRA is consulting on the future regulation of medical devices in the UK. Powers in the Medicines and Medical Devices Act (2021) allow the MHRA to amend the Medical Devices Regulations 2002 which govern medical devices regulation in…
The Medical Device Coordination Group (MDCG) has published the following updates: MDCG number Notes MDCG 2021- 23 Guidance for notified bodies, distributors and importers on certification activities in accordance with Article 16(4) of Regulation (EU) 2017/745 and Regulation (EU) 2017/746…
The TGA. Australia has provided further information on the reclassification of of software based medical devices. Recent changes to regulation of software based medical devices The regulatory changes came into effect on 25 February 2021 as previously reported in this…
The UK MHRA is seeking views on innovative medicines manufacture at point of care. It has launched a consultation on a proposed regulatory framework for Point of Care (POC) manufacturing. What is POC manufacturing? POC manufacturing refers to the manufacture…
Health Canada is consulting on revised guidance of Post-Notice of Compliance (NOC) Changes – Quality. Draft revised guidance documents on Post-Notice of Compliance (NOC) Changes – Quality have been released for stakeholder consultation. Who is the focus of the consultation?…
Last updated 25 October 2024 To view updates, click on the ‘+’ sign below. The UK MHRA has launched the Early Access to Medicines Scheme (EAMS) consultation. What is the EAMS scheme? How does the scheme work? EAMS is essentially…
Last updated: 2 October 2024 See update at the end of the post. The European Medicines Agency (EMA) issued a draft guideline in August for comments, on core Summary of Products Characteristics (SmPC), labelling and package Leaflet for ATMPs containing…
The US FDA recently approved a new use of a transplant drug based on real-world evidence (RWE). It provides an opportunity to learn more above the use of real world data (RWD) and real world evidence (RWE) in drug reegistration.…
The EU Simultaneous National Scientific Advice (SNSA) pilot has been extended to the end of 2021 due to the COVID-19 pandemic, in order to allow additional experience to be gained. About the SNSA pilot The EU Innovation Network started a…