UK Updates
The UK’s PMS Overhaul: A New Era for Medical Device Safety
On June 16, 2025, the MHRA ushered in the first major reform of Post-Market Surveillance (PMS) regulations across Great Britain, reshaping how medical devices and IVDs are monitored after market entry.
Read our detailed blog on the UK's Post-Market Surveillance (PMS) reforms and what it means for manufacturers, notified bodies, and compliance stakeholders. Click here to read the full blog.
Key Changes Impacting Manufacturers:
In our latest blog, we have discussed:
European Updates
MDCG 2025-5: Clarifying Performance Study Expectations Under EU IVDR
As clinical evidence requirements becomes crucial across the EU under Regulation (EU) 2017/746, the European Commission’s latest guidance—MDCG 2025-5—provides critical clarifications on how performance studies for in vitro diagnostic medical devices (IVDs) should be planned, submitted, and conducted.
The Q&A-style document released in June 2025, addresses several vital areas that have challenged manufacturers, sponsors, and investigators alike.
Key clarifications include:
As IVDR’s clinical evidence expectations tighten, this guidance assists as a vital tool for sponsors navigating EU performance studies.
New EU Guidance: Safe Distribution of Medical Device Software (MDSW) Apps on Online Platforms
With software-based health solutions rising, MDCG 2025-4 offers timely clarity on how Medical Device Software (MDSW) apps are made available on online platforms.
The European Commission has released MDCG 2025-4, offering key guidance to ensure that Medical Device Software (MDSW) apps made available on digital platforms comply with EU MDR.
Highlights:
With MDSW playing a vital role in diagnostics and therapy, this guidance is crucial to maintaining patient safety and digital trust in an evolving regulatory environment.
It is must-read for software developers, manufacturers, and platform providers navigating the EU digital health space.
EU Revises MDCG 2019-11: Strengthening Clarity on Software Qualification & Classification under MDR/IVDR
On June 17, 2025, the European Commission shared an updated version of MDCG 2019-11 Rev.1. This update explains how software is classified and qualified under the EU Medical Device Regulation (MDR 2017/745) and the In Vitro Diagnostic Regulation (IVDR 2017/746).
What’s New in Rev.1?
This revision clarifies important ideas and provides practical examples to help classify software consistently across the EU. Key updates include:
Why This Matters ?
For software developers and regulatory teams, these updates clarify confusing areas, like products that are on the border of being medical or not. They also show the EU’s acknowledgment of quickly changing technology, such as clinical decision support systems and wearables, which require clear compliance guidelines.
By better defining software qualification thresholds, MDCG 2019-11 Rev.1 supports:
Final Thought: As digital health becomes crucial in healthcare, following this updated guidance is not just about meeting regulations; it’s a smart strategy to reduce risks in software innovation for the EU market.
USFDA Updates
FDA’s New Draft Guidance on 510(k) Transfers: What MedTech Companies Need to Know
Introduction The U.S. Food and Drug Administration (FDA) has taken a significant step toward clarifying one of the most common—yet often ambiguous—processes in the medical device industry: the transfer of a 510(k) clearance.
In its newly released draft guidance, “Transfer of a Premarket Notification (510(k)) Clearance – Questions and Answers,” the FDA provides long-awaited answers to critical questions surrounding ownership changes, mergers and acquisitions (M&A), and licensing agreements.
Key Takeaways from the Draft Guidance
Required Documentation:
In order to complete the transfer, documents which must be submitted to the FDA:
No FDA Re-Evaluation of the 510(k)
During a transfer the FDA does not re-review the safety or effectiveness of the device. The process is purely organizational. The new owner assumes responsibility for compliance. The device’s intended use, indications, and technological characteristics remain unchanged.
Liability & Compliance Shifts to the New Owner
During a transfer the FDA does not re-review the safety or effectiveness of the device. The process is purely organizational. The new owner assumes responsibility for compliance. The device’s intended use, indications, and technological characteristics remain unchanged.
Liability & Compliance Shifts to the New Owner
Once the transfer is completed the new owner becomes fully responsible for post-market surveillance, reporting adverse events, and FDA inspections.
Implications for Medical Device Manufacturers
Conclusion The FDA’s draft guidance on 510(k) transfers is a major step forward in streamlining medtech transactions while ensuring continued regulatory compliance. By clarifying roles, documentation, and processes, the FDA is reducing uncertainty in M&A, licensing, and corporate restructuring—key drivers of innovation in the medical device industry.
ABHI Updates
Industry Collaboration in Action!
On 3 June 2025, ABHI hosted insightful group calls bringing together key stakeholders from the medical technology and life sciences sectors.
Sushvin consultants were pleased to join the ABHI (Association of British HealthTech Industries) Group Call on 3 June 2025, where members gathered to discuss the latest developments in UK medical device regulation.
These discussions focused on the latest regulatory updates, industry challenges, and collaborative solutions shaping the future of healthcare innovation.
Highlights from the session included:
These sessions continue to be a valuable platform for collaboration, clarity, and regulatory preparedness. A huge thank you to ABHI for facilitating such an open, engaging platform to share knowledge and align strategies across the sector.
Australian Updates
Australia’s TGA Reinforces Manufacturer Evidence Requirements for ARTG Inclusion
The Therapeutic Goods Administration (TGA) has emphasized its expectations for Manufacturer Evidence, which is essential for adding medical devices and in vitro diagnostic devices (IVDs) to the Australian Register of Therapeutic Goods (ARTG).
What Is Manufacturer Evidence?
Manufacturer Evidence is the documentation that shows a manufacturer is following the necessary rules and standards, usually by having a quality management system (QMS). This documentation ensures that a product meets Australia’s key safety, quality, and performance standards.
The Manufacturer Evidence Identifier
Sponsors must submit their conformity assessment documents through the TGA Business Services (TBS) portal. Once accepted, the TGA provides a Manufacturer Evidence Identifier, which is crucial for most ARTG applications, except for these categories:
Acceptable Evidence May Include:
Why This Matters
Manufacturer Evidence provides the TGA with assurance that a product is manufactured in accordance with internationally accepted quality and safety benchmarks. It is a core pillar of Australia’s risk-based medical device regulatory framework, ensuring transparency, traceability, and vigilance readiness post-approval.
Final Thought: As regulations change, submitting Manufacturer Evidence accurately and on time is crucial for market access. Sponsors should prepare their documentation and internal systems in advance to prevent delays during ARTG submission.
At Sushvin Consultancy, we are closely monitoring these developments and are here to help you navigate the evolving regulatory landscape. Let’s work together to ensure these changes drive innovation while safeguarding public health.
Canada Updates
Health Canada Drafts New Path for Biosimilar Approvals: Toward a More Efficient, Evidence-Based Model
Health Canada has introduced a new draft guideline called "Information and Submission Requirements for Biosimilar Biologic Drugs" (June 2025), which is now open for public feedback. This draft objective is to make the process of developing biosimilars in Canada easier while maintaining patient safety and scientific accuracy intact.
What's New?
The updated guidelines include several important changes that bring Canada in line with international standards, especially those from the UK, Australia, and parts of the EU.
Other Updates Include:
The revised guidance proposes several notable changes that align Canada with evolving global regulatory standards—particularly those seen in the UK, Australia, and some EU countries.
Phase III Clinical Trials Not Required in Most Cases
Health Canada suggests that confirmatory Phase III trials will not be required unless there are still scientific doubts after looking at the analytical and pharmacokinetic data.
Greater Emphasis on Analytical and PK/PD Comparability
Sponsors should provide a strong comparison package using advanced analysis methods and pharmacokinetic/pharmacodynamic (PK/PD) data, instead of relying on clinical efficacy trials, to demonstrate bio similarity.
Simpler Justification for Indication Extrapolation
The revised draft simplifies the process of extrapolating therapeutic indications from the reference product, removing the need for exhaustive rationale where the mechanism of action and safety profiles are well understood.
Additional Updates
Final Thought: Stakeholders are requested to submit feedback before 8 September 2025, offering a pivotal opportunity for industry voices to influence the future of biosimilar regulation in Canada.
Malaysian Updates
Malaysia Updates ASEAN Harmonised Classification Guidance for Medical Devices
Malaysia’s Medical Device Authority (MDA) has released the Third Edition of its Guidance Document on the Harmonised Classification of Medical Devices in ASEAN (MDA/GD/0062) in June 2025. This updated guideline—published annually—lists risk-based classifications (Classes A–D) for both general and in vitro diagnostic (IVD) medical devices, aligning Malaysia with the ASEAN Medical Device Directive (AMDD) and the decisions of the ASEAN Medical Device Committee (AMDC). This is part of Malaysia's effort to work together with other countries in the region on medical device regulations.
Purpose of the Guidelines
These guidelines aim to help manufacturers, importers, and healthcare professionals understand how medical devices and in-vitro diagnostics (IVDs) are classified in Malaysia and under ASEAN rules. They support Malaysia’s national laws, including:
Key Highlights
Why It Matters
These guidelines make it easier for medical devices to enter the ASEAN market, helping manufacturers plan better and understand regulations more clearly. They also show Malaysia's growing influence in setting regulatory standards in Southeast Asia.
Final Thought: For medical technology developers looking at the ASEAN market, understanding Malaysia’s classification system is crucial. These updated guidelines provide important clarity and contribute to regional cooperation in regulations.
South Africa Updates
South Africa’s SAHPRA Mandates ISO 13485 Certification for Medical Device Establishment Licences
The South African Health Products Regulatory Authority (SAHPRA) has announced that, from 1 June 2025, a valid ISO 13485:2016 certificate will be a mandatory prerequisite for the approval or renewal of Medical Device Establishment Licences.
What’s Changing?
Manufacturers and distributors (importers) of medical devices and in vitro diagnostics (IVDs) must now submit either:
This applies to:
Why ISO 13485?
ISO 13485 is the international standard for quality management systems (QMS) in the medical device and IVD fields. It helps ensure that products are safe, effective, and made consistently according to regulations.
SAHPRA’s decision to implement this requirement aligns South Africa with global best practices and emphasizes its commitment to patient safety.
Implications for Industry
Final Thought: This change is not just a compliance update—it indicates that quality assurance is now crucial for market access in South Africa. Manufacturers and distributors should act quickly to meet the new requirements and maintain their licensing status.
Sri Lanka Updates
Sri Lanka Grants GMP Inspection Waiver for Low-Risk Medical Devices
The National Medicines Regulatory Authority (NMRA) of Sri Lanka has announced a two-year waiver on GMP inspections for Listed and Class 1 medical devices—effective from 10 May 2025 to 9 May 2027.
This initiative aims to simplify the registration process for low-risk medical devices. In doing so it is paving the way for long-term alignment with international quality standards.
What’s Changing?
Under this initiative, manufacturers of Listed and Class 1 devices are no longer required to undergo prior GMP inspection before applying for product registration. In its place they must submit:
Upon evaluation, the Manufacturing Regulatory Division (MFRD) will issue a GMP Waiver Document, which must accompany the product registration file in lieu of GMP certification.
Implications for Manufacturers
For device manufacturers, both local and international, the waiver signifies a regulatory opportunity in the increasingly competitive South Asian market. The benefits of this waiver include:
Final Thought: The NMRA’s GMP waiver is not just a temporary relief but it highlights Sri Lanka’s commitment to smarter regulation. Manufacturers who act now can benefit this opportunity to enter and expand within the Sri Lankan market.
Sushvin Provides UK Responsible Person (UK RP) Services
Are you a legal medical device/IVD manufacturer located outside the UK and would like to market your product in the UK, then you will require a UK responsible person who will act on behalf of the manufacturer to ensure all the responsibilities detailed within the updated UK MDR 2002 regulations are met.
As a legal manufacturer, organisations will have to register their devices prior to be placed on the UK market.
If you need UK Responsible Person (UK RP) services, please contact SUSHVIN for more information.
If you are planning to market your product in the EU and if you require PRRC (Person Responsible for Regulatory Compliance), we have a team of experienced regulatory professionals who can help you assist with PRRC services and get you regulatory compliant as per MDR 2017/745 and IVDR 2017/746
If you need PRRC Services, please contact SUSHVIN for more information.
