TGA Amends Clinical Decision Support System Exemption
The TGA has amended the Clinical Decision Support System exemption to clarify when it applies, with amendments taking effect from 1 November 2026 and no change to the exemption scope or new regulatory requirements.
TGA Updates Classification Rules for Certain Combination Products
The TGA has introduced a new classification rule for certain non-invasive saline-only medical devices used to maintain patency or flush the lumen of another medical device, classifying them as Class IIa under Clause 2.2.
Swissmedic Updates Technical Interpretation on Market Release and Pre-Wholesaler Distribution
Swissmedic has updated its technical interpretation on market release and distribution in cooperation with a pre-wholesaler, clarifying MAH responsibilities, quality agreements, outsourced activities, traceability, audits, retention samples and GDP compliance.
Swiss Federal Council Announces Measures on IVD Supply and Medical Device Transparency
The Swiss Federal Council has announced measures to extend IVD transition periods, continue simplified labelling requirements for certain IVDs and introduce medical device and IVD product registration in swissdamed from 2026.
European Commission JRC Report Examines Health Consequences of Cyber Incidents in Healthcare
The European Commission Joint Research Centre has published a study on cyber security in the health and medicine sector, analysing evidence of patient health consequences resulting from cyber incidents in healthcare settings.
FDA Draft Guidance Explains Drug Master File Submission and Review Expectations
FDA’s draft guidance on Drug Master Files explains DMF types, submission format, original and subsequent submissions, letters of authorization, annual reports, FDA review policies and DMF closure.
TGA Publishes Updated Overview of UDI for Australian Healthcare
The TGA has published version 3.0 of its overview of Unique Device Identification for Australian healthcare, explaining UDI concepts, AusUDID, phased implementation, healthcare adoption, reporting and device-specific requirements.
MHRA-NICE Real-World Evidence Scientific Dialogue Now Accepts Medical Device Applications
The MHRA-NICE Real-World Evidence Scientific Dialogue has been updated to include applications relating to RWE and medical devices, with Approved Bodies represented in relevant workshops.
Health Canada Updates Forms for Exceptional Importation and Sale of Medical Devices
Health Canada has updated forms FRM-0577 and FRM-0578 for exceptional importation and sale of foreign-authorized medical devices, including new web forms, supporting documentation fields and a shorter shipment notification timeframe.
Swissmedic Updates swissdamed Business Rules to Version 5.0
Swissmedic has updated the swissdamed Business Rules technical document to version 5.0, covering UDI-DI registration, legacy devices, Master UDI-DI, certificate rules, device data exchange and SRN format requirements.
MDSAP Updates Special Remote Assessment Procedure
MDSAP has updated its Special Remote Assessment Procedure, describing how remote assessments of auditing organizations are planned, performed, documented and reviewed within the Medical Device Single Audit Program.
Swissmedic Updates Information Sheet on Notification of Quality Defects
Swissmedic has updated its information sheet on notification of quality defects for medicinal products and active pharmaceutical ingredients, including reporting obligations, timelines, contact points, measures and fees.
FDA Issues Final Guidance on 510(k) Submissions for Dental Curing Lights
FDA has issued final guidance on premarket notification 510(k) submissions for dental curing lights, covering device description, predicate comparison, labeling, reprocessing, biocompatibility, software, cybersecurity, electrical safety, wireless technology and non-clinical performance testing.
Swissmedic Updates Formal Requirements Guidance Document to Version 22.0
Swissmedic has updated its Formal requirements guidance document to version 22.0, setting out administrative and submission requirements for applications, variations, medicinal product information, packaging, combination products, DMF/ASMF and special product types.
FDA Updates Breakthrough Devices Program Information and 2026 Designation Data
FDA’s Breakthrough Devices Program provides expedited interaction and prioritized review for eligible medical devices intended to treat or diagnose life-threatening or irreversibly debilitating diseases or conditions.
TGA Updates Guidance on COVID-19 Rapid Antigen Test Performance and Risk Mitigation
The TGA has updated its guidance on performance requirements and risk mitigation for COVID-19 rapid antigen tests, covering analytical and clinical evidence, self-test usability, IFU requirements, software, COR approvals and post-market monitoring.
MedTech Europe and Mecomed Highlight MDR and IVDR Impact on International Registrations in MEA
MedTech Europe and Mecomed have published considerations on the impact of the EU MDR and IVDR transition on international registrations in the Middle East and Africa, calling for a harmonised and risk-based approach to change management.
WHO Publishes Policy Considerations to Improve Access to Refractive Error Care
WHO has published policy considerations to improve access to refractive error care, focusing on spectacles, service access, workforce capacity, population education, cost reduction, surveillance and research.
EMA Updates List of CECP Opinions Issued by Medical Device Expert Panels
EMA has updated the list of CECP opinions issued by Expert Panels for medical devices undergoing conformity assessment, supporting transparency in the Clinical Evaluation Consultation Procedure.
EU Preliminary Draft 2027 AUWP Includes Standardisation Request for Medical Devices and IVDs
The preliminary draft 2027 Annual Union Work Programme for European standardisation includes a standardisation request for medical devices and IVDs under Regulations (EU) 2017/745 and 2017/746.