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.
IMDRF Publishes 2026 Document Implementation Report
IMDRF has published its 2026 Document Implementation Report, providing the self-identified implementation status of IMDRF technical documents across member jurisdictions.
TGA Updates Guidance on IVD Self-Tests for Chlamydia, Gonorrhoea and Syphilis
The TGA has updated its guidance on clinical performance and risk mitigation requirements for IVD self-tests for chlamydia, gonorrhoea and syphilis, including study design, usability, IFU and post-market monitoring expectations.
Anvisa Publishes Guidance Manuals for Medical Device Regularization
Anvisa has published two guidance manuals for the regularization of IVD devices and notification of risk class I and II medical devices, aiming to improve dossier quality and reduce technical requirements and rejections.
Health Canada Announces Changes to Special Access Program Application Process for Medical Devices
Health Canada has announced changes to the Special Access Program application process for medical devices, including a new accessible application form, secure submission method and mandatory use from 1 February 2027.
Anvisa Publishes Manual on Notification of Risk Class I and II Medical Devices
Anvisa has published a manual on the notification process for risk class I and II medical devices in Brazil, covering company regularization, product classification, Solicita electronic submission, documentation requirements and secondary petitions.
European Commission Launches Survey on Electronic Instructions for Use for Medical Devices
The European Commission is considering allowing electronic instructions for use for all professional-use medical devices and has launched a survey for healthcare professionals and healthcare institutions in the EU.
FDA Publishes Discussion Paper on Regulation of Generative AI-Enabled Medical Devices
FDA has published a discussion paper seeking stakeholder feedback on regulatory considerations for generative AI-enabled medical devices, including risk assessment, premarket evaluation, benchmarking, clinical confirmation, postmarket monitoring and foundation models.
FDA Issues Draft Guidance on Potency Assessment of Active Immunotherapy Products
FDA has issued draft guidance on potency assessment of active immunotherapy products, covering potency assays, critical quality attributes, bioassays, physicochemical assays and product-specific considerations.