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Global Regulatory Press

Global Regulatory Press is the publisher of the Journal of Medical Device Regulation and e-books on medical device regulatory affairs.

09/12/2025

Regulatory News from Thailand:

Certain documents do not need to be submitted for medical device licence or notification renewals.

Subscribe now to read the full story: globalregulatorypress.com

20/11/2025

NEW: CORE Subscription Licence - designed for micro medtech RA teams

We are pleased to announce the launch of the JMDR CORE Licence - a new subscription type designed specifically for compact regulatory teams who need access for two professionals.

Over the past year, many readers told us that their regulatory teams were growing, often from one to two specialists, and that they needed a practical way to share full access without moving to a larger multi-user licence.

We listened.

Why the CORE Licence?
The CORE Licence is ideal for:

- Compact medtech regulatory teams (2 people)
- Start-ups and scale-ups
- Consultants working closely with a single colleague

It offers full JMDR access for exactly two named users, including:

✔️ All articles and news updates in every issue
✔️ Complete archive and full-text search
✔️ Unlimited downloads
✔️ Personal access for each user (no shared login)

CORE provides the same depth of content, functions and search capabilities as all other JMDR licences.
Only the number of users differs.

Learn more
If you would like to explore whether CORE is the right subscription for your team, or if you are ready to activate access, then simply email us at [email protected] or visit our website: GlobalRegulatoryPress.com

19/11/2025

Regulatory News update from Switzerland:

With immediate effect: Implementation of the EU requirements for the electronic provision of instructions for use.

Read the full story and subscribe now: GlobalRegulatoryPress.com

17/11/2025

Regulatory News from Malaysia:

Restructured fees charged for the registration of Class A medical devices.
Subscribe now to read the full story: globalregulatorypress.com

11/11/2025

Regulatory News from Canada:

Guidance for determining medical device application type published.

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06/11/2025

Regulatory News from Hong King:

New Technical Reference on artificial intelligence in medical devices has been published.

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05/11/2025

Regulatory News from Spain:

-> Collaboration between AEMPS and CEIm on the evaluation of clinical investigations and performance studies.

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04/11/2025

Now available: “The UKCA – Now, Next and Navigating Ahead” (free)

A new webinar recording featuring Teresa Perry (Peritus Regulatory Consulting® Ltd Regulatory Consulting)

Originally held live in October, this webinar explores the current state of UK medical device regulation, key developments on the horizon, and what manufacturers should do now to stay prepared.

👉 Watch the full recording on the Journal of Medical Device Regulation Global Regulatory Press website and get clear, practical insights into navigating the evolving UKCA landscape.

https://globalregulatorypress.com/services/medical-device-podcasts/

03/11/2025

Regulatory News from Australia:

TGA seeks input on digital mental health tools. Submit your information until 1 December 2025.

Subscribe to the JMDR today to read the full story:

https://globalregulatorypress.com/our-shop/buy-a-subscription-to-the-jmdr/

28/10/2025

Regulatory changes in your target markets, soon 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 issue, the Regulatory Monitor will update you on legislative changes in:

Australia, Brazil, Canada, Chile, China, Denmark, Ecuador, Egypt, EU, Finland, Hong Kong, India, Ireland, Italy, Malaysia, Norway, Philippines, Portugal, Spain, Switzerland, UK, Ukraine, and the USA.

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

24/10/2025

New Focus article coming in the JMDR November 2025 issue:
"The EU Data Act – how manufacturers lose control over connected device data"
Regulation (EU) 2023/2854 – the European Union (EU) Data Act – which largely became applicable on 12 September 2025, introduces a paradigm shift in data governance by granting users enforceable rights to access data generated by connected products, including connected medical devices.
This article by Cécile van der Heijden examines the profound implications of the Data Act for the medical technology industry. The Act mandates data accessibility by design, real-time user access to device and service-generated data, and the facilitation of data sharing with third parties under fair, reasonable, and non-discriminatory terms. Medical device manufacturers are classified as data holders and must adapt to obligations that extend across a broad digital ecosystem encompassing cloud platforms, remote monitoring services, and software components.
The Act further imposes restrictions on contractual terms, requires new pre-contractual transparency measures, and demands architecture that enables data portability and service switching.
This article outlines how these obligations challenge conventional models of data ownership, contractual arrangements, and product design in the medical technology sector. Far from a marginal compliance issue, the Data Act constitutes a structural overhaul with significant strategic and operational consequences for medical technology companies operating in the European Economic Area.

22/10/2025

New Focus article coming in the JMDR November 2025 issue:

"Converging regulations: the EU’s WFD, SCIP reporting, the ESPR, and the future of sustainable medical device design"

As the European Union (EU) advances its circular economy agenda, medical device manufacturers find themselves at a regulatory crossroads where chemical safety, product design, and end-of-life management converge. Historically governed by frameworks focused on patient safety and chemical compliance, the medical technology sector must now also contend with the evolving requirements of the EU Waste Framework Directive (WFD), the SCIP (Substances of Concern In articles, as such or in complex objects (Products)) database for hazardous substance reporting, and the Ecodesign for Sustainable Products Regulation (ESPR).

This article by Emma Owens examines the intersection of these regulatory demands, highlighting the specific challenges posed by medical devices’ complex designs, sterility requirements, and limited recyclability.

It also outlines actionable strategies for manufacturers to prepare for ESPR-driven obligations.

Ultimately, the convergence of safety and sustainability regulations presents not only a compliance challenge but also an opportunity for the sector to align with broader EU goals and design medical devices that are both safe for patients and compatible with a sustainable future.

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