Global Regulatory Press

01/10/2026

Regulatory News from Kyrgyz Republic:

*Proposed suspension of marketing authorisations without valid inspection report*

Subscribe to the JMDR now to read the full story:
GlobalRegulatoryPress.com

28/09/2026

*JMDR strengthens its Asia Pacific regulatory expertise with the appointment of Jack Wong to its Editorial Advisory Board*
We are delighted to welcome Jack Wong, Founder of the ARPA - Asia Regulatory Professionals Association, to the Editorial Advisory Board of the Journal of Medical Device Regulation.

With more than 26 years’ experience across pharma and medtech, Jack brings a wealth of regulatory expertise and a strong Asia Pacific perspective to the JMDR’s international regulatory affairs community.

As founder of the ARPA, now with more than 9,000 members, Jack has played a significant role in advancing regulatory education and professional development across the region.

His experience also spans academia, biotechnology, health AI and start-up innovation, alongside his involvement with industry and professional organisations, including the DIA.

Jack’s appointment further strengthens the JMDR’s international editorial network and our commitment to providing practical, authoritative and globally relevant insights into medical device regulation.

Welcome to the JMDR Editorial Advisory Board, Jack!

22/09/2026

Did you miss the latest live JMDR podcast?

The recording of our exclusive podcast session, “What do international medical device manufacturers often get wrong when entering the Brazilian market?”, is now available to subscribers of the Journal of Medical Device Regulation (JMDR).

In this special session, Eliana Silva de Moraes, a medical device legal and regulatory expert specialising in the Brazilian market and a member of the Journal’s Editorial Board, shares practical insights into the challenges, pitfalls and regulatory considerations that international manufacturers should understand before entering Brazil.

The recording is available exclusively to JMDR subscribers.

Interested in becoming a JMDR subscriber? Please contact us at GlobalRegulatoryPress.com.

21/09/2026

Regulatory news update from Japan:

*Conditional approval system for innovative medical devices now in effect*

Subscribe now to read the full story: GlobalRegulatoryPress.com

08/09/2026

Regulatory news from Australia:
*Updated guidance on overseas regulatory evidence might affect your TGA application*.

Subscribe now to read the full story.

👉 GlobalRegulatoryPress.com

07/09/2026

*Free article on regulatory divergence of NIRS-based technologies*

Courtesy of the authors Zhao Jianjun and Li Zhenfang, we are excited to offer complimentary access to a featured article from the August issue of the Journal of Medical Device Regulation (JMDR):

*Regulatory divergence of NIRS-based technologies: distinguishing cerebral oximeters and fNIRS devices under international 80601 standards*

By addressing long-standing terminology overlap and inconsistent application of the NIRS designation across device types, this 11-page article highlights critical regulatory implications for classification, approval pathways, and clinical claims. It further outlines practical recommendations for strengthening regulatory clarity, improving awareness of international standards, and reducing misapplication risks.

After reading this article, readers should be able to:
- Distinguish between cerebral oximeters and fNIRS devices based on intended use, measurement principles, and regulatory scope.
- Explain how ISO 80601-2-85 and IEC 80601-2-71 define different validation and performance expectations.
- Identify regulatory and compliance risks arising from ambiguous terminology or unsupported clinical claims.
- Apply classification and standards’ selection principles when evaluating NIRS-based device submissions, labelling, and promotional materials.

This article was originally published in the JMDR August 2026 issue and is now available to download free of charge.

We hope you find this expert contribution valuable in your day-to-day regulatory work.
https://globalregulatorypress.com/product/regulatory-divergence-of-nirs-based-technologies-distinguishing-cerebral-oximeters-and-fnirs-devices-under-iec-80601-standards/

18/08/2026

10/08/2026

🎙️ Exclusive JMDR Podcast Session – This Afternoon

What do international medical device manufacturers often get wrong when entering the Brazilian market?

This afternoon, JMDR subscribers will have exclusive access to a special podcast session with Eliana Silva de Moraes, a medical device legal and regulatory expert specialising in the Brazilian market and also member of the JMDR Editorial Board.

Eliana will share practical insights into the challenges, pitfalls and regulatory considerations that international manufacturers should understand before entering Brazil.

This session is exclusively available to JMDR subscribers.

If you are interested in becoming a subscriber to the JMDR then please contact us: GlobalRegulatoryPress.com

21/07/2026

As NIRS-based technologies continue to evolve, understanding the regulatory distinction between cerebral oximeters and functional near-infrared spectroscopy (fNIRS) devices is essential for manufacturers, regulatory professionals, and conformity assessment bodies.

This article examines the evolving IEC 80601-2-85 and IEC 80601-2-71 standards, explaining how these technologies have diverged in intended use, validation requirements, and regulatory classification. It also explores the implications for regulatory submissions, device labelling, clinical claims, and standards selection.

A valuable resource for anyone involved in the development, assessment, or regulation of NIRS-based medical devices.

Pre-order your copy today: https://globalregulatorypress.com/product/regulatory-divergence-of-nirs-based-technologies-distinguishing-cerebral-oximeters-and-fnirs-devices-under-iec-80601-standards/

20/07/2026

As Egypt continues to develop its medical device regulatory framework, understanding the requirements for market access and compliance is becoming increasingly important.

In this practical article, Ilona Putz provides a comprehensive overview of the Egyptian Drug Authority (EDA) regulatory system, covering:

• The legal and institutional framework
• Risk-based device classification aligned with EU MDR principles
• Registration, importation, and approval procedures
• Requirements for manufacturers, importers, distributors, and Egyptian Registration Holders
• Labelling and packaging requirements
• Post-market surveillance, vigilance, renewals, and variations
• Regulatory timelines, fees, and appeals

An essential resource for regulatory affairs professionals, manufacturers, importers, and anyone involved in bringing medical devices to the Egyptian market.

This article will be published in the August 2026 issue of the Journal of Medical Device Regulation (JMDR, Global Regulatory Press)

Pre-order your copy today: https://globalregulatorypress.com/product/an-overview-of-the-medical-device-regulations-in-the-arab-republic-of-egypt/

GlobalRegulatoryPress.com