UK Updates
UK Consultation on Indefinite Recognition of CE Marked Devices
On 16 February 2026, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) launched a targeted consultation on the indefinite recognition of CE marked medical devices in Great Britain. This development is very important in the UK’s post-Brexit regulatory framework for patient safety, innovation and international alignment.
Transition from CE to UKCA
Importance of this consultation
The government is evaluating whether CE marked devices should be indefinitely recognized in GB, allowing continued marketing without additional UKCA conformity assessment.
The Three Proposals
1. Extend the current GB transitional arrangements for devices that comply with the EU Medical Device Directive to align with the transitional timelines published by the EU
-This aligns GB timelines with the EU, allowing devices under the Medical Device Directive (MDD) to remain on the market until 31 December 2028 instead of 30 June 2028.
2. Indefinitely recognise devices that comply with the EU Medical Device Regulation and EU In Vitro Diagnostic Medical Device Regulation
-Indefinite recognition of CE marked devices that comply with EU MDR(2017/745) /IVDR(2017/746) , potentially allowing them to remain on the GB market without UKCA conformity assessment.
3. Introduce an international reliance route for devices that comply with the EU Medical Device Regulation and EU In Vitro Diagnostic Medical Device Regulation where the risk classification is higher under MDR 2002.
-Devices which are classified as a higher risk under UK MDR 2002 compared to the EU, introduce an international reliance pathway. Manufacturers could maintain CE access until December 2030, followed by reliance or UKCA assessment.
Conclusion
The MHRA’s consultation on indefinite CE recognition is a crucial policy decision for the UK MedTech sector. It highlights the government’s goal which is to make the UK a leader in medical technologies by 2030.
The consultation is open until 10 April 2026. Industry stakeholders and healthcare professionals are encouraged to contribute to the future of medical device regulation in Great Britain.
Visit the official MHRA website for more information
European Updates
MDSAP Audit Approach
The Medical Device Single Audit Program (MDSAP) marks a crucial advancement in harmonizing regulatory oversight for the medical device industry. By allowing a single audit system to meet the requirements of multiple regulatory authorities, MDSAP reduces duplication, simplifies compliance, and enhances the reliability of medical device quality systems on a global scale.
The Importance of MDSAP
Medical device companies often struggle with different regulatory demands across different regions. MDSAP addresses this issue through a process-based audit model that include:
This integrated framework ensures compliance across different markets through a single audit.
The Audit Process
The MDSAP audit employs a logical, risk-based sequence to evaluate the effectiveness of a medical device organization’s Quality Management System (QMS). The core processes include:
Supporting processes like Device Marketing Authorization & Facility Registration and Adverse Event/Advisory Notice Reporting ensure compliance with jurisdiction-specific requirements.
Key task for manufacturers
Conclusion
The MDSAP Audit Approach is not just a checklist it is a strategic framework that involves risk-based thinking, process integration, and global regulatory alignment. It is very important for medical device organizations because implementation MDSAP will encourage in building a robust, transparent, and globally recognized quality system.
For guidance visit Sushvin https://lnkd.in/ghhvbEec
𝗖𝗼𝗻𝗰𝗲𝗽𝘁 𝗽𝗮𝗽𝗲𝗿 𝗼𝗻 𝘁𝗵𝗲 𝗿𝗲𝘃𝗶𝘀𝗶𝗼𝗻 𝗼𝗳 𝘁𝗵𝗲 𝗘𝗨 𝗚𝗠𝗣 𝗚𝘂𝗶𝗱𝗲𝗹𝗶𝗻𝗲𝘀 - 𝗔𝗻𝗻𝗲𝘅 𝟭𝟱 (𝗤𝘂𝗮𝗹𝗶𝗳𝗶𝗰𝗮𝘁𝗶𝗼𝗻 𝗮𝗻𝗱 𝗩𝗮𝗹𝗶𝗱𝗮𝘁𝗶𝗼𝗻)
On February 9, 2026, the European Medicines Agency (EMA) and the Pharmaceutical Inspection Co-operation Scheme (PIC/S) began public consultation on a concept paper to revise Annex 15 of the EU GMP guidelines.
Annex 15 has been optional for active substance manufacturers. However, the N-nitrosamine contamination in sartans (2018–2020) highlighted gap in process knowledge, contamination control, and GMP compliance.
Key highlights
Impact on Industry
Timeline
Conclusion
The revision of Annex 15 is a significant move towards mandatory, harmonized qualification and validation requirements for active substance manufacturers. By implanting quality risk management and enhancing oversight of validation practices, regulator’s purpose is to address gaps exposed by past impurity crises and ensure medicines remain safe, effective, and high quality.
USFDA Updates
Understanding the FDA’s 2026 Cybersecurity Guidance for Medical Device Manufacturers
In February 2026, the U.S. Food and Drug Administration (FDA) released its latest guidance titled Cybersecurity in Medical Devices: Quality Management System Considerations and Content of Premarket Submissions.
This guidance applies to devices with cybersecurity threats, including device software functions or devices containing software or programmable components. It is not limited to network-enabled devices or those with connected features.
The guidance outlines recommendations for cybersecurity information to be included in the following premarket submissions to the Center for Devices and Radiological Health (CDRH) or the Center for Biologics Evaluation and Research (CBER):
Quality Management System (QMS) Considerations
The FDA stresses the importance of integrating cybersecurity across the entire product lifecycle.
Requirements for Premarket Submissions
Manufacturers must include detailed cybersecurity documentation in their submissions. The FDA specifies several important components:
Future Outlook
The FDA’s 2026 guidance reflects a global trend to treat cybersecurity as fundamental to medical device safety. Cybersecurity must be embedded within the QMS to demonstrate resilience, meet compliance requirements, and build trust.
Conclusion
Cybersecurity has become a regulatory cornerstone in medical device development. The FDA’s guidance makes it clear that safeguarding patients requires protecting devices throughout their lifecycle.
For guidance visit Sushvin: https://lnkd.in/ghhvbEec
To read more visit: https://www.fda.gov/
FDA's New Compliance Program for Medical Device Inspections (CP 7382.850)
On February 2, 2026, the U.S. Food and Drug Administration (FDA) published its updated Compliance Program Manual (CP 7382.850) for inspecting medical device manufacturers. This new program replaces previous frameworks and reflects the FDA’s updated approach to risk-based oversight, alignment with international standards, and inclusion of cybersecurity in device compliance.
Key Highlights of CP 7382.850
1. Risk-Based Inspection Approach
Inspections are prioritized by risk profiles, product categories, and compliance history. Categories include baseline surveillance, compliance follow-up, for-cause inspections, and specific product risk assignments.
2. Alignment with ISO 13485
The FDA has aligned its Quality Management System Regulation (QMSR) with ISO 13485:2016 and ISO 9000:2015 Clause 3.
3. Broadened Oversight Scope
Covers Premarket Approval (PMA), Medical Device Reporting (MDR), Tracking Requirements, Corrections and Removals, Registration & Listing, and Unique Device Identification (UDI). Includes the Medical Device Single Audit Program (MDSAP) and references recent legislative updates (FDARA, FDORA, and the Consolidated Appropriations Act 2023).
4. Cybersecurity
Cybersecurity is now a key inspection focus area. Inspectors will assess design, development, and post-market practices to ensure devices are protected against cyber threats.
5. Lifecycle Evaluation
Total Product Life Cycle (TPLC) assessment, incorporating design, manufacturing, distribution, and post-market surveillance. Includes benefit-risk considerations and patient perspectives.
6. Specialized Areas
Industry Implications
Final Thoughts
The updated FDA Compliance Program 7382.850 marks a new era of medical device oversight that is risk-based, internationally harmonized, and cyber-aware. Manufacturers must comply with these requirements not only for regulatory reasons but also to build safe, quality, and resilient devices.
To read more visit: https://www.fda.gov/
For guidance visit Sushvin: https://lnkd.in/ghhvbEec
Australian Updates
Regulating Software-Based Medical Devices: Australia’s 2026 Guidance
On 24 February 2026, the Australian Therapeutic Goods Administration (TGA) released new guidance on regulating software-based medical devices (SaMD), including artificial intelligence (AI) and digital health technologies.
Importance
Software plays a crucial role in medical care, from diagnostic apps to AI-driven risk prediction tools. However, not all health apps qualify as medical devices. The TGA guidance outlines how the intended purpose determines regulation and the obligations that arise once software is classified as a medical device.
Who Is Regulated
Key Concepts
Types of Software-Based Medical Devices
ARTG Inclusion Process
Classification Rules
Essential Principles
Manufacturers must comply with safety and performance principles throughout the device lifecycle. For software, three principles are key:
Post-Market Obligations
Conclusion
The TGA’s February 2026 guidance offers clarity for developers and sponsors navigating the complex field of SaMD. By focusing on intended purpose, classification, and ongoing compliance, Australia ensures that digital health innovation is accompanied by robust patient safety measures.
Hong Kong Updates
Hong Kong Updates Medical Device Administrative Control System (MDACS)
In February 2026, the Hong Kong Department of Health released Technical Reference TR 007:2026(E), updating the Medical Device Administrative Control System (MDACS). It outlines requirements for Software in a Medical Device (SiMD), Software as a Medical Device (SaMD), and cybersecurity.
Key Highlights of TR 007:2026(E)
1. Scope and Definitions
2. Classification
3. Documentation Requirements
4. Software-Specific Standards
5. Post-Market Management
Industry Implications
Conclusion
Hong Kong’s TR 007:2026(E) emphasizes that software itself can be a medical device, and cybersecurity is vital for patient safety. By establishing clear guidelines for SiMD, SaMD, and cybersecurity, MDACS positions Hong Kong as a leader in digital health regulation.
To read more visit: https://lnkd.in/gGwpbpcB
South Korea Updates
South Korea’s 2026 Medical Device GMP Regulations
In February 2026, South Korea's Ministry of Food and Drug Safety (MFDS) published updated Medical Device Good Manufacturing Practice (GMP) Regulations.
Importance of the Update
Previously, South Korea's GMP framework was localized, requiring separate adaptation from international systems. The 2026 update harmonizes requirements, reduces duplication, and introduces specialized standards for digital health, AI-driven devices, and in vitro diagnostics.
Key Highlights
The updated framework includes four distinct GMP standards:
Part 1: Enforcement Rule of the Medical Devices Act (Effective Oct 31, 2025)
Part 2: Standards of Good Manufacturing Practice for Medical Devices (Effective Dec 9, 2025)
Part 3: Standards of Good Manufacturing Practice for In Vitro Diagnostic Medical Devices (Effective Aug 12, 2025)
Part 4: Standards of Good Manufacturing Practice for Digital Medical Devices (Effective Apr 21, 2025)
Manufacturer Action Points
Manufacturers should:
Conclusion
This 2026 update highlights South Korea's commitment to a robust and modern regulatory framework. It strengthens foundational requirements for all medical devices while introducing dedicated and detailed provisions for rapidly advancing fields such as in vitro diagnostics and AI-powered digital medical devices.
To read more visit: https://lnkd.in/dttUb6V6
IMDRF Updates
Harmonizing Adverse Event Reporting: IMDRF’s 2026 Guidance
The International Medical Device Regulators Forum (IMDRF) has released its latest guidance — IMDRF/AET WG/N86 FINAL:2026, titled Considerations for the Selection of IMDRF Adverse Event Terminology.
This document marks a crucial step toward achieving consistent, precise, and globally harmonized reporting of adverse events for medical devices.
Importance
Adverse event reporting is crucial for post-market surveillance. Without standardized terminology, regulators and manufacturers may struggle to detect signals, validate risks, and respond quickly to protect public health. IMDRF’s harmonized coding system builds on previous GHTF work and offers a structured, universally applicable framework.
“Widespread use of a single, appropriate adverse event terminology and coding system is expected to improve signal detection and validation by adverse event management systems, enabling a faster response by both industry and regulatory authorities for public health safety.” (IMDRF/AET WG/N86 FINAL:2026)
Coding Framework
The IMDRF terminology is divided into seven groups across four code sets:
| Code Group | Purpose | Example |
|---|---|---|
| A Codes | Medical Device Problem | False Positive Result [A090804] |
| G Codes | Device Component | Battery [G02002] |
| E Codes | Clinical Signs/Symptoms | Intracranial Hemorrhage [E1402] |
| F Codes | Health Impact | Death [F02] or No Health Consequences [F26] |
| B Codes | Type of Investigation | Laboratory Testing [B03] |
| C Codes | Investigation Findings | Electrical Component Problem [C0201] |
| D Codes | Investigation Conclusion | Cause Traced to Component Failure [D02] |
These codes collectively provide a complete picture of the event — from device malfunction to patient impact, and the manufacturer’s root cause analysis.
Key Coding Principles
The Bigger Picture
By aligning terminology across jurisdictions, IMDRF enables:
This guidance is not just technical — it is strategic and compliance-driven. It empowers regulators and industry stakeholders to communicate effectively when patient safety is at stake.
Egypt Updates
Egypt Proposes New Guideline for Biological Product Registration and Re-registration
On February 8, 2026, the Egyptian Drug Authority (EDA) released a draft guideline (EDREX.GL.Bioinn.004, Version 5/2026) for public consultation. This document outlines the structure and content requirements for the registration and re-registration of biological products, aligning Egypt's regulatory practices with international standards such as the ICH Common Technical Document (CTD).
Key Highlights
Scope & Definitions
Documentation Requirements
Packaging
Labelling
Patient Information Leaflet (PIL)
Summary of Product Characteristics (SmPC)
The SmPC must align with regulatory requirements and provide comprehensive scientific information supporting safe and effective product use.
Industry Impact
Conclusion
The EDA’s draft guideline for biological product registration and re-registration highlights Egypt’s commitment to international alignment, patient safety, and regulatory strengthening. Public consultation is now open, allowing stakeholders to contribute to the final version before adoption.
Indian Updates
New Draft Guidance on Importing In Vitro Diagnostic Medical Devices by CDSCO
The Central Drugs Standard Control Organization (CDSCO) has issued a Draft Guidance Document in January 2026 for the import of In Vitro Diagnostic (IVD) medical devices into India. This document, now open for public feedback, aims to simplify the licensing process, clarify regulations, and ensure adherence to the Medical Devices Rules, 2017 (MDR 2017).
Purpose of the Guidance
The draft outlines a step by step process for importers to submit product licence applications via the CDSCO online portal and the National Single Window System (NSWS).
Key Highlights
1. Licensing Authority
The Central Licensing Authority (CLA) under CDSCO will issue import licences for all IVD classes (Class A–D).
2. Classification of IVDs
Devices are categorized by risk:
3. Types of Import Applications
4. Regulatory Pathways
Defined pathways for test licences, clinical evaluations, fresh imports, endorsements, and renewals.
Integration with NSWS portal for test licences and CDSCO online portal for commercial imports.
5. Checklist and documents
Detailed checklists for MD 16 (test licence) and MD 14 (import licence) applications. Required documents include:
6. Stakeholder Roles
7. Timelines & Non Compliance
Conclusion
This draft guidance represents a significant move toward clarity, efficiency, and harmonization in regulating IVD imports in India. Stakeholders are advised to review the draft and submit comments within the 15 day.
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.
