Global Regulatory Press

24/07/2025

Sneak Preview JMDR August 2025 issue:
India’s regulatory framework for software as a medical device (SaMD)

This article by Sundeep Agarwal offers an in-depth look into India's regulatory framework for SaMD, serving as a critical guide for developers, manufacturers, and importers aiming to bring their digital health solutions to the Indian market successfully.

India’s regulatory landscape for SaMD is rapidly evolving in response to the healthcare sector’s growing reliance on digital innovations such as artificial intelligence, wearables, and telehealth.

Under the Medical Devices Rules, 2017, the Central Drugs Standard Control Organization has established a comprehensive framework to govern SaMD throughout the total product lifecycle - from design and development to post-market surveillance. This includes risk classifications, stringent quality management requirements, clinical investigations for higher-risk devices, and a detailed registration process.

With recent mandates for version tracking, mandatory labelling, and continuous monitoring, both domestic and international stakeholders must navigate a dynamic, compliance-driven environment.

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Also in the August issue:
Regulatory news updates from:
Australia, Brazil, China, Denmark, Egypt, EU, France, Germany, Hong Kong, India, Japan, Malaysia, Mexico, Philippines, Portugal, Singapore, South Africa, Switzerland, UK, Ukraine, and the USA....

23/07/2025

Sneak Preview JMR August 2025 issue:
Overview of the regulatory requirements for medical devices in Switzerland

This article by Daniel Delfosse of Swiss Medtech provides a comprehensive overview of the regulatory framework for medical devices in Switzerland.
It focuses on Swiss-specific regulatory elements, following the expiration of the Mutual Recognition Agreement with the European Union (EU) on 26 May 2021, and explores the current legal framework and anticipated revisions.

Emphasis is placed on additional Swiss requirements that go beyond EU regulations, and a new pathway intended to permit US Food and Drug Administration-approved or -cleared devices to enter the Swiss market.

17/07/2025

Sneak Preview JMDR August 2025 issue:

A comparative analysis of the US and EU performance-based regulatory pathways with recommendations for harmonisation

Regulatory frameworks for medical devices have historically balanced innovation with patient safety. Yet, as medical technologies become increasingly modular, software enabled and patient specific, traditional regulatory models face growing limitations. This article by Haroon Atchia critically compares the US Food and Drug Administration’s Safety and Performance Based Pathway (SPBP) and Article 18(3) of the European Union’s (EU) Medical Device Regulation.

Although both regulatory mechanisms aim to reduce unnecessary burdens for mature technologies, they differ significantly in implementation, scope and operational clarity.

Ultimately, the findings support an EU-specific adaptation of the SPBP principles, and the article proposes recommendations for harmonising and modernising the EU regulatory framework accordingly.

11/06/2025

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03/06/2025

Regulatory News from the EU:

! Pilot coordinated assessment for clinical investigations or performance studies launched

Subscribe to the Journal of Medical Device Regulation now to read the full story.

02/06/2025

29/05/2025

Regulatory News from

Spain:
:: Procedure for publishing clinical research reports in the absence of EUDAMED.

-> Read the full story and subscribe to the Journal of Medical Device Regulation today.

21/05/2025

Regulatory News from

United Kingdom:
:: The Medical Devices (Amendment) (Great Britain) Regulations 2025 will come into force on 24 May.

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22/04/2025

Last day to take up on our 15% off Spring Sales offer on new subscriptions to the JMDR.

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