Global Regulatory Press

16/10/2025

In the upcoming JMDR November 2025 issue:

Regulatory Monitor:
>>Global coverage of regulatory developments, organised by world region and country, so you can track and compare requirements wherever your company operates.

The Regulatory Monitor section includes vital information – both pre- and post-market – from classification and registration requirements to clinical investigations, standards and labelling to name but a few.

>>In the JMDR November, the Regulatory Monitor will update you on legislative changes in:
Australia, Brazil, Canada, Chile, China, Denmark, Ecuador, Egypt, EU, Finland, Hong Kong, India, Italy, Malaysia, Norway, Philippines, Portugal, Spain, Switzerland, UK, Ukraine, and the USA ...

->Subscribe to the JMDR now through our website globalregulatorypress.com.

15/10/2025

Are you developing a first-of-its-kind medical device? Bringing your breakthrough device to market faster?
The FDA’s Breakthrough Devices Program can shorten timelines - but only if you understand how to use it strategically.

Our upcoming JMDR article explains how to navigate the pathway effectively:
“Best practices for obtaining breakthrough designation using the US FDA’s Breakthrough Devices Program”

The US Food and Drug Administration’s (FDA’s) Breakthrough Devices Program is intended to expedite the development and review of medical devices that offer more effective treatment or diagnosis for life-threatening or irreversibly debilitating conditions.
This article by John Doucet, PhD provides a comprehensive overview of the Program’s structure, designation criteria, and special regulatory interaction mechanisms available to device manufacturers.
It outlines best practices for obtaining a breakthrough designation, emphasising the importance of early submission, clear definition of indications for use, and alignment on standard of care.
Common pitfalls in designation requests are also identified, including overly broad or vague indications and insufficient evidence.
Finally, the article highlights the benefits of the Program, including streamlined communications, regulatory flexibility, and increased engagement opportunities.

30/09/2025

12/09/2025

Subscribe now, add a colleague for free.
With our special offer, one of your colleagues can join your Journal of Medical Device Regulation single user (SOLO) subscription for one year at no extra cost, giving both of you access to expert analyses, worldwide regulatory updates, and the fully searchable archive.

How it works:
1. Go to our subscription page and choose the single user licence SOLO.
2. Follow the steps and use coupon code SOLO2for1 at the checkout
3. Write the name and email address of your colleague who will receive free access in the “Order Notes” section of the checkout page.

*Offer valid until midnight 10 October 2025. Applicable to new subscriptions only. Not applicable to subscription renewals or other subscription types. Complimentary access is for one year.

This is why you should subscribe:
: For start-ups: the JMDR provides the critical knowledge you need to achieve market access.
: For established companies: the JMDR helps you understand and implement regulatory changes seamlessly, minimising delays and compliance risks.
: For global players: the JMDR offers an international perspective, so you can anticipate and adapt to regulatory developments across all your key markets.

Each issue of the JMDR combines:
: Expert-written analyses of regulatory frameworks and updates.
: Global coverage of the most important changes in medical device law.
: Practical usability, including searches by keyword, topic and/or country across the entire JMDR archive, available exclusively to subscribers.

11/09/2025

New Podcast Available: AI Act
The Journal of Medical Device Regulation has released a recording of our recent live session:
“The many ambiguities of the European Union’s Artificial Intelligence Act.”

Our sincere thank you to our expert speaker Cécile van der Heijden, one of the top 100 MedTech Leading Voices, for leading the live session and providing valuable insights.

Based on her in-depth article written for the Journal, the discussion explores the AI Act’s implications for the medical device industry and includes a live Q&A with attendees of the event.

The podcast is now available for download on our homepage.
Listen here: https://globalregulatorypress.com/services/medical-device-podcasts/

02/09/2025

Regulatory News Update from Brazil:

Are you aware of the new mandatory UDI requirements for Class IV medical devices?

Subscribe now to read the full story.

25/08/2025

Regulatory News update from Egypt:

Did you see that the application links to obtain a CFS for a medical device or an in vitro diagnostic reagent have been activated?

Subscribe now to read the full story.

22/08/2025

Regulatory news update from Germany:

There is a new version of the German Medical Devices Information and Database System (DMIDS) module ‘Clinical Trials and Performance Studies’.

Did you know about it?

Subscribe to the JMDR now to read the full story:
https://globalregulatorypress.com/our-shop/buy-a-subscription-to-the-jmdr/

21/08/2025

Regulatory news from EU:

Don’t forget to use the new version of the manufacturer incident report (MIR) form

Subscribe today and read the full story.

20/08/2025

Do you need to understand and implement the Network and Information Systems (NIS) 2 Directive?

The Danish Agency for Social Security has published 4 guidance documents to help the device industry understand and implement the requirements of the law.

Subscribe to the JMDR and read the full story.