News & Press Releases

• Regulatory Bulletin June 2021 28th May 2021 Posted in: News - June's Regulatory Bulletin for subscribers to the Journal of Medical Device Regulation covers regulatory changes in: Australia Brazil China El Salvador the EU Indonesia Japan Korea (Republic of) Pakistan Switzerland USA What are Regulatory Bulletins? Regulatory Bulletins contain news snippets… Read More
• Podcast: Q&A session on regulatory requirements for medical devices and IVDs in Ecuador 24th May 2021 Posted in: News - Cristina Murgueitio, Executive Director of ASEDIM – Ecuador’s medical device association – answers the following questions posed by JMDR subscribers in our new FREE podcast: Is Ecuador’s medical device legislation in accordance with the laws of, for example, the USA… Read More
• Podcast: The impact of COVID-19, as well as current and future challenges, for the Australian TGA 18th May 2021 Posted in: News - Tracey Duffy & Prof. John Skerritt of the Australian Therapeutic Goods Administration (TGA) talk exclusively to Marija Capek of the JMDR. Tune in to the FREE podcast. Tracey Duffy leads the team specialising in medical device assessments and pre- and… Read More
• Podcast: How should manufacturers update their QMS to meet the requirements of the European MDR? 11th May 2021 Posted in: News - Stephanie Goebel & Ortzi Olasolo from Beyond Conception talk to the JMDR about how to make a Quality Management System ready for the EU MDR. Watch/listen to our FREE PODCAST. Stephanie Goebel is Senior Consultant at Beyond Conception GmbH. She… Read More
• Juan Olivares Leon joins the Journal of Medical Device Regulation as Editorial Correspondent for South America 26th January 2021 Posted in: Press Releases - The Journal of Medical Device Regulation is delighted to welcome Juan Olivares Leon as its new Editorial Correspondent for South America. "Juan will be a great asset in terms of sourcing and evaluating information, as well as feeling the pulse… Read More
• The Journal of Medical Device Regulation welcomes Dr Christina Zimmer from the German Medical Technology Association BVMed as new Editorial Advisory Board member 3rd December 2020 Posted in: Press Releases - The Journal of Medical Device Regulation (JMDR) is thrilled to welcome Dr Christina Zimmer as the newest member of its Editorial Advisory Board. Christina is the new Deputy Director General of the German Medical Technology Association BVMed, where she succeeds… Read More
• A focus on medical device regulation in the UK after Brexit, a regulatory country overview on Peru, reusable ophthalmic devices, views on biological evaluation from the Italian AFI Regulatory Affairs Working Group, the regulation of SaMD in the USA, and much more now available in the November 2020 edition of the Journal of Medical Device Regulation 10th November 2020 Posted in: Press Releases - London, 10 November 2020 – The Journal of Medical Device Regulation releases today the contents of its November 2020 issue to non-subscribing readers. The following articles are now publicly available through the Journal’s website – GlobalRegulatoryPress.com – 10 days after… Read More
• Views and positions on current regulatory issues from the US FDA, the American Dental Association, the Italian Medical Device Manufacturers Association and many more now available in the August 2020 edition of the Journal of Medical Device Regulation 11th August 2020 Posted in: Press Releases - London, 11 August 2020 – The Journal of Medical Device Regulation releases today the contents of its August 2020 issue to non-subscribing readers. The following articles are now publicly available through the Journal’s website – GlobalRegulatoryPress.com – 10 days after… Read More
• Everything manufacturers need to know about the new EU IVDR, requirements for new interactions with Notified Bodies for combination products, promotion of devices in the USA through new media, medical reversals and retractions in clinical evaluations, and updated rules for Argentina now available from the Journal of Medical Device Regulation 10th May 2020 Posted in: Press Releases - London, 10 May 2020 – The Journal of Medical Device Regulation releases today the contents of its May 2020 issue to non-subscribing readers. The following articles are now publicly available through the Journal’s website – GlobalRegulatoryPress.com – 10 days after… Read More
• The impact of the new EU Market Surveillance Regulation, China’s regulatory reforms in 2020, Advertising under the European MDR/IVDR, Classification of borderline devices, Egypt’s device regulations, and an Analysis of the new US guidance on nitinol-containing medical devices now available from the Journal of Medical Device Regulation 10th February 2020 Posted in: Press Releases - London, 10 February 2020 – The Journal of Medical Device Regulation releases today the contents of its February 2020 issue to non-subscribing readers. The following articles are now publicly available through the Journal’s website – GlobalRegulatoryPress.com – 10 days after… Read More