UK Updates
UK and US Collaboration on MedTech and AI
On 8 October 2025, the UK Medicines and Healthcare products Regulatory Agency (MHRA) and the US Food and Drug Administration (FDA) agreed to work even closer to improve medical technology and artificial intelligence (AI) in healthcare.
This announcement was made during the AdvaMed Conference in San Diego, where MHRA Chief Executive Lawrence Tallon and FDA Director Dr. Michelle Tarver outlined a shared vision for global regulatory harmonization.
What This Means?
Both agencies want to help new medical devices and AI tools reach patients faster. They want to make sure medical products are safe and effective. They want to make it easier for companies to sell devices in both countries without repeating the same regulatory steps.
National AI Commission
The MHRA has started a new National AI Commission that includes UK and US experts, as well as technology leaders from companies like Google and Microsoft. Their goal is to create clear and safe rules for using AI in healthcare and hospitals, especially across the NHS.
Reliance Routes
A major part of the plan is introducing International Reliance Routes for faster approval. This means the MHRA can accept medical devices already approved by trusted regulators like the FDA, saving time and avoiding repeated reviews. This new system is expected to start in 2026–2027.
Benefits for the NHS and Businesses
The UK’s National Health Service (NHS) will give companies a large real-world environment to test AI innovations and collect data. This helps new technologies prove their safety and effectiveness more quickly. Patients will get access to advanced medical devices sooner.
Manufacturers will spend less time and money on duplicate approvals.
Final Thoughts
This partnership marks a big step toward global cooperation in medical technology. By aligning their rules and working together, the UK and US are helping to bring safe, modern healthcare innovations to patients faster and more efficiently. This UK-US partnership sets a new benchmark for international regulatory cooperation. To read more visit
MHRA Device Registration Fees
The UK's Medicines and Healthcare products Regulatory Agency (MHRA) will change its device registration fees starting 1 April 2026. This cmoves from a one-time fee to an annual fee model based on Level 2 GMDN Categories. This means manufacturers and UK Responsible Persons will need to manage their device registrations differently for the Great Britain market.
What’s Changing?
Until 31 March 2026
From 1 April 2026
What to do before 30 March 2026?
To prepare and avoid account issues, manufacturers and UK Responsible Persons should check and update: -
Make sure:
Accounts that remain suspended by 17:00 on 30 March 2026 will be closed. Devices will need to re-register under the new fee model to keep selling devices.
Strategic Implications
This change highlights the need for portfolio management and correct GMDN® categorization. Manufacturers should check their registrations and combine them, if possible, to reduce fees.
Final Thoughts
The MHRA’s move to an annual fee model shows a trend towards better oversight and data accuracy in device regulation. By preparing early, everyone can avoid disruptions and meet new regulatory requirements. To read more visit
European Updates
EU Publishes Procedural Rules for Joint Clinical Assessments – Implementing Regulation (EU) 2025/2086
On 17 October 2025, the European Commission adopted Commission Implementing Regulation (EU) 2025/2086. It gives clear, practical rules and templates for how Joint Clinical Assessments (JCAs) of medical devices (MDs) and in vitro diagnostics (IVDs) will be run across the EU under the HTA Regulation.
What the regulation covers?
Key Features of Regulation (EU) 2025/2086
Structured timelines:
Practical actions for manufacturers and professionals
Final Thoughts
Commission Implementing Regulation (EU) 2025/2086 marks a critical milestone in the HTA Regulation (EU 2021/2282). By establishing clear procedural rules and standardized templates, the EU strengthens its commitment to transparent, evidence-based evaluation of medical technologies.
EU Confirms Harmonized Standards for Infection Control – Implementing Decision (EU) 2025/2078
On 17 October 2025, the European Commission issued Implementing Decision (EU) 2025/2078, amending Implementing Decision (EU) 2021/1182 and formally adopting four harmonized standards under the Medical Device Regulation (MDR). These standards set clear technical and safety expectations for surgical clothing and drapes, medical face masks, and sterilizers.
The four standards (2025 versions)
Recommended actions for stakeholders
Key takeaways -
Final Thoughts
Final Thoughts The adoption of Commission Implementing Decision (EU) 2025/2078 marks a pivotal step in strengthening the regulatory foundation for infection control across the European Union. By incorporating these standards into the MDR, the EU Commission provides manufacturers and notified bodies with clearer pathways to compliance, enhanced product safety and streamlined market access. At Sushvin Consultancy, we continue to track these developments to support our clients in maintaining global compliance and strategic readiness.
For guidance visit us at visit us at
USFDA Updates
FDA's New QMSR Draft Guidance
In October 2025, the U.S. Food and Drug Administration (FDA) introduced new draft guidance called Quality Management System Information for Certain Premarket Submission Reviews. This document explains how manufacturers should include QMS details in submissions like 510(k), De Novo, and PMA.This guidance supports the transition from the legacy Quality System Regulation (QSR) to the globally harmonized Quality Management System Regulation (QMSR), effective February 2, 2026.
Purpose of the Guidance
Key Points of the Guidance
The guidance outlines how to include QMS information in submissions, focusing on: -
Risk-Based Review Approach
The FDA will use a risk-based approach to evaluate QMS information, considering:
Integration with eSTAR
The guidance works well with the FDA's eSTAR format, allowing manufacturers to:
Strategic implications for manufacturer
Manufacturer must ensure ISO 13485 certification and inspection records are updated. Prepare concise QMS summaries for the FDA. Manufacturer must align documentation with QMSR and ISO 13485 for easier multi-market submissions.
Final Thoughts
The FDA’s draft guidance on QMS information is an important procedural update. It represents a step toward modernizing regulations. By adopting international standards and digital submission formats, the FDA is making device approvals faster, safer, and more predictable.
Australian Updates
A Guide to Australia's New Medical Device Cybersecurity Requirements
As medical devices become more connected and software-driven, cybersecurity is essential. On October 2, 2025, the Therapeutic Goods Administration (TGA) published new guidance called “Complying with Medical Device Cybersecurity Requirements.” This document is important for manufacturers and sponsors in Australia, particularly those creating devices with software.
Key Points of the TGA Cybersecurity Requirements
1. Lifecycle Approach
Cybersecurity should be considered throughout the entire product lifecycle from design to monitoring and end-of-life. This includes: -
2. Pre-Market Requirements
Manufacturers need to show:
3. Post-Market Vigilance
Sponsors should:
4. Global Consistency
The TGA’s expectations align with international regulators like:
This helps Australian manufacturers stay competitive globally while meeting local standards.
Why This Matters
Cybersecurity issues can affect device performance, patient safety, and data security. With the increasing use of AI, wearables, and cloud-connected platforms, the risks are higher. The TGA’s guidance emphasizes that cybersecurity is a vital part of regulatory compliance.
Tips for Manufacturers
Final Thoughts
The TGA’s updated guidance highlights that cybersecurity is crucial for medical device safety and effectiveness. Manufacturers must prioritize cybersecurity not just as a regulatory requirement but as a key strategy. By incorporating these principles into the development and compliance processes, manufactures can better protect patients and meet global standards. To read more visit
Australia’s TGA Updates CDx Guidance: A Strategic Framework for Precision Diagnostics
Therapeutic Goods Administration (TGA) released a significant update to its guidance on in vitro diagnostic (IVD) companion diagnostics (CDx). This document outlines the regulatory framework for CDx devices and their corresponding medicines or biologicals, supporting Australia’s commitment to precision medicine and global harmonization.
What Is a CDx?
A companion diagnostic (CDx) is an IVD medical device that provides information essential for the safe and effective use of a specific medicine or biological.
Key Regulatory Highlights
1. Classification & ARTG Inclusion
2. Companion Testing Plan Options
Sponsors must choose one of four pathways to demonstrate how CDx testing will be available in Australia:
Option
Pathway Description
3. Concurrent Submissions Encouraged
4. In-House CDx Pathway
Final Thoughts
Australia’s updated CDx guidance reflects a maturing regulatory landscape that embraces precision diagnostics, risk-based oversight, and international harmonization. For sponsors developing targeted therapies or diagnostic platforms, this framework offers clarity, structure, and strategic opportunity.
For Detailed Updates Visit
Malaysia Updates
Malaysia’s Updated Medical Device Registration Process
The Medical Device Authority (MDA) of Malaysia has published a new guide (MDA/GD/0070, October 2025) outlining the updated steps for registering medical devices using the Medical Device Centralised Online System (MeDC@St) .
Key Highlights:
Verification Pathway
According to the Medical Device Act 2012 (Act 737), all medical devices must be assessed for conformity before registration. However, devices already approved by recognized regulatory agencies (like FDA, TGA, EU Notified Bodies, HSA Singapore, or Thai FDA) can take a simpler route called the verification pathway.
This pathway is for:
Key Updates in the Second Edition
Fees :
Class Application Fee (RM) Registration Fee (RM)
Submission Essentials
Final Thought
This updated guidance shows MDA’s commitment to making the registration process more efficient while ensuring safety standards are met.
To read more visit
Brazil Updates
Brazil's 2025 Medical Device Manual Update
On October 22, 2025, Brazil's health authority, ANVISA, released a major update to its medical device regulations. This update modernizes the rules, especially for software-based and digital health technologies.
What’s New in the manual?
The updated manual provides clear step – by – step guidance for companies entering Brazil's health-tech market. This shows ANVISA’s focus on harmonization, transparency, and digital transformation.
Key Areas:
Strategic Implications for manufacturers
This update positions Brazil as a leader in digital health regulation. This means manufacturer must
Sushvin Consultancy Recommendations:
Final Thoughts
Brazil’s 2025 update is more than just a regulatory change it’s a move toward global standards. ANVISA is embracing innovation offering manufacturers a chance to expand confidently. By embracing international standards, clarifying software-specific pathways, and digitizing submission, Brazil is preparing its readiness to support innovation while safeguarding public health.
To read the full documents visit manual-regularizacao-gquip
ISO Updates
ISO’s October 2025 Update: Medical Devices and Product Updates
The ISO updates in October 2025 bring important changes for medical devices, focusing on quality, safety, and innovation. Here are the key points for manufacturers and stakeholders:
Main Standards in Progress
1. Quality Management
2. Biological and Clinical Evaluation
3. Implants
4. Sterilization and Packaging
5. Anaesthetic and Respiratory Equipment
Updates address video laryngoscopes (ISO 7376-2:2025), lung ventilator semantics (ISO 19223-3:2025), and sleep apnoea therapy masks (ISO 17510:2025).
6. Health Informatics and Labelling
Actions for Manufacturers
Conclusion
The October 2025 ISO update aim for safer, higher-quality, and globally aligned medical devices reflecting advancements in technology and global standardization. Manufacturers who adapt to these changes will be better equipped to offer safer, higher-quality products, ensuring smoother market entry and continued success.
India Updates
CDSCO Draft Guidance on Medical Device Software
India's Central Drugs Standard Control Organisation (CDSCO) has issued a draft Guidance Document on Medical Device Software (October 2025), clarifying the regulatory path for healthcare software and aligning with global standards.
Importance of the Guidance
The document highlights the essential role of software in healthcare, from AI diagnostics tools to apps for chronic disease management. It addresses ambiguities in the Medical Devices Rules (MDR), 2017, by:
Key Highlights
1. Regulation clarity: SaMD vs. SiMD
The guidance clearly distinguishes between two main types of medical device software:
2. Risk Classification System for SaMD For SaMD, the guidance introduces a practical, two-factor matrix for risk classification (Class A, B, C, D)
3. Technical and QMS Requirements
Focus on Cybersecurity and AI/ML: Standards like IEC 81001-5-1 (cybersecurity) and IS/ISO/IEC 42001 (AI management) are highlighted.
4. Regulatory Pathway
The guidance provides flowcharts that simplify the journey from concept to market:
5. Post-Market Vigilance
The guidance stresses on robust Post-Marketing Surveillance (PMS)
Industry implications
India's framework is harmonizing with international standards (IMDRF, EU MDR), making it easier to plan market entry.
Public Feedback
CDSCO has invited all stakeholders to provide their feedback via a Google Form within 30 days of its publication.
Link to provide comments
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.
