https://globalregulatorypress.com/issue_articles/uk-guidance-on-registration-of-certain-devices-reliant-on-expired-or-expiring-ce-certificates-or-declarations-of-conformity/ 2025-04-30T11:29:58+00:00 https://globalregulatorypress.com/issue_articles/usa-modifications-to-the-list-of-fda-recognised-standards/ 2025-04-30T11:29:59+00:00 https://globalregulatorypress.com/issue_articles/a-comparative-analysis-of-the-us-and-eu-performance-based-regulatory-pathways-with-recommendations-for-harmonisation/ 2025-08-01T07:02:40+00:00 https://globalregulatorypress.com/issue_articles/an-overview-of-the-regulatory-requirements-for-medical-devices-and-ivds-in-uganda/ 2025-08-01T07:02:42+00:00 https://globalregulatorypress.com/issue_articles/australia-therapeutic-goods-restricted-representations-wound-dressings-permission-2025/ 2025-08-01T07:02:43+00:00 https://globalregulatorypress.com/issue_articles/australia-guidance-on-the-regulatory-requirements-for-ivd-cdx-has-been-revised/ 2025-08-01T07:02:44+00:00 https://globalregulatorypress.com/issue_articles/australia-medical-devices-exempt-from-pfas-ban/ 2025-08-01T07:02:45+00:00 https://globalregulatorypress.com/issue_articles/australia-specified-articles-and-excluded-products-in-the-regulation-of-personalised-medical-devices/ 2025-08-01T07:02:47+00:00 https://globalregulatorypress.com/issue_articles/australia-unique-device-identification-update-on-compliance-dates/ 2025-08-01T07:02:48+00:00 https://globalregulatorypress.com/issue_articles/australia-updated-guidance-on-the-regulation-of-custom-made-medical-devices/ 2025-08-01T07:02:49+00:00 https://globalregulatorypress.com/issue_articles/brazil-udi-for-class-iv-medical-devices-now-mandatory/ 2025-08-01T07:02:50+00:00 https://globalregulatorypress.com/issue_articles/china-good-manufacturing-practice-for-medical-devices/ 2025-08-01T07:02:51+00:00 https://globalregulatorypress.com/issue_articles/china-guiding-principles-and-key-points-drafted-for-public-comment/ 2025-08-01T07:02:53+00:00 https://globalregulatorypress.com/issue_articles/china-guiding-principles-published-2/ 2025-08-01T07:02:54+00:00 https://globalregulatorypress.com/issue_articles/china-measures-to-support-the-innovative-development-of-high-end-medical-devices/ 2025-08-01T07:02:55+00:00 https://globalregulatorypress.com/issue_articles/china-medical-device-registration-review-guidelines-compilation-plan-for-2025/ 2025-08-01T07:02:56+00:00 https://globalregulatorypress.com/issue_articles/china-new-and-revised-medical-device-industry-standards/ 2025-08-01T07:02:57+00:00 https://globalregulatorypress.com/issue_articles/china-quality-management-standards-for-online-sales-of-medical-devices/ 2025-08-01T07:02:58+00:00 https://globalregulatorypress.com/issue_articles/china-three-medical-device-industry-standards-abolished/ 2025-08-01T07:03:00+00:00 https://globalregulatorypress.com/issue_articles/china-updated-catalogues-of-medical-devices-and-ivd-reagents-exempt-from-clinical-evaluation/ 2025-08-01T07:03:01+00:00 https://globalregulatorypress.com/issue_articles/denmark-guidance-documents-published-on-nis-2-directive/ 2025-08-01T07:03:02+00:00 https://globalregulatorypress.com/issue_articles/egypt-activation-of-the-application-links-to-obtain-a-cfs/ 2025-08-01T07:03:03+00:00 https://globalregulatorypress.com/issue_articles/eu-answers-to-frequently-asked-questions-on-the-interplay-between-the-mdr-ivdr-and-the-artificial-intelligence-act/ 2025-08-01T07:05:31+00:00 https://globalregulatorypress.com/issue_articles/eu-commission-restricts-chinese-participation-in-medical-devices-procurement/ 2025-08-01T07:05:33+00:00 https://globalregulatorypress.com/issue_articles/eu-designation-of-an-additional-expert-panel-and-other-administrative-changes/ 2025-08-01T07:05:34+00:00 https://globalregulatorypress.com/issue_articles/eu-electronic-instructions-for-use-are-permitted-for-all-professional-use-medical-devices-and-their-accessories/ 2025-08-01T07:05:35+00:00 https://globalregulatorypress.com/issue_articles/eu-guidance-on-the-safe-making-available-of-mdsw-apps-on-online-platforms/ 2025-08-01T07:05:36+00:00 https://globalregulatorypress.com/issue_articles/eu-joint-clinical-assessments-of-medical-devices-and-in-vitro-diagnostics/ 2025-08-01T07:05:37+00:00 https://globalregulatorypress.com/issue_articles/eu-latest-update-on-the-targeted-evaluation-of-the-mdr-and-ivdr/ 2025-08-01T07:05:38+00:00 https://globalregulatorypress.com/issue_articles/eu-master-udi-to-apply-for-spectacle-frames-spectacle-lenses-and-ready-to-wear-reading-spectacles/ 2025-08-01T07:05:40+00:00 https://globalregulatorypress.com/issue_articles/eu-mdcg-2025-5-answers-questions-on-ivd-performance-studies-under-the-ivdr/ 2025-08-01T07:05:41+00:00 https://globalregulatorypress.com/issue_articles/eu-mdcg-2025-7-sets-out-timelines-for-the-implementation-of-master-udi-di-for-contact-lenses-spectacle-frames-spectacle-lenses-and-ready-to-wear-reading-spectacles/ 2025-08-01T07:05:42+00:00 https://globalregulatorypress.com/issue_articles/eu-new-version-of-mir-form-released/ 2025-08-01T07:05:43+00:00 https://globalregulatorypress.com/issue_articles/eu-proposed-establishment-of-an-expert-panel-on-orphan-and-paediatric-devices/ 2025-08-01T07:05:44+00:00 https://globalregulatorypress.com/issue_articles/eu-updated-guidance-on-qualification-and-classification-of-software-in-the-mdr-and-ivdr/ 2025-08-01T07:05:46+00:00 https://globalregulatorypress.com/issue_articles/france-ansm-publishes-a-regulatory-guide-for-manufacturers-of-ocular-prostheses/ 2025-08-01T07:05:47+00:00 https://globalregulatorypress.com/issue_articles/germany-new-version-of-dmids-clinical-trials-and-performance-studies-module/ 2025-08-01T07:05:48+00:00 https://globalregulatorypress.com/issue_articles/hong-kong-new-technical-reference-on-personalised-medical-devices/ 2025-08-01T07:05:49+00:00 https://globalregulatorypress.com/issue_articles/hong-kong-tr-007-on-software-medical-devices-and-cybersecurity-has-been-updated/ 2025-08-01T07:05:50+00:00 https://globalregulatorypress.com/issue_articles/india-cdsco-to-eliminate-loan-licence-requirement-for-outsourced-sterilisation/ 2025-08-01T07:05:52+00:00 https://globalregulatorypress.com/issue_articles/indias-regulatory-framework-for-software-as-a-medical-device-samd/ 2025-08-01T07:05:53+00:00 https://globalregulatorypress.com/issue_articles/japan-biological-safety-evaluation-review-points-published/ 2025-08-01T07:05:54+00:00 https://globalregulatorypress.com/issue_articles/japan-checklist-for-certification-of-medical-device-software-based-on-existing-notices/ 2025-08-01T07:08:18+00:00 https://globalregulatorypress.com/issue_articles/malaysia-proposed-revision-of-guidance-on-special-access-exemption-scheme/ 2025-08-01T07:08:19+00:00 https://globalregulatorypress.com/issue_articles/malaysia-updated-guidance-drafted-for-export-only-medical-devices/ 2025-08-01T07:08:20+00:00 https://globalregulatorypress.com/issue_articles/malaysia-updated-lists-of-borderline-product-determinations-and-risk-classifications-in-line-with-the-asean/ 2025-08-01T07:08:22+00:00 https://globalregulatorypress.com/issue_articles/mexico-new-agreement-extends-regulatory-reliance-options-for-medical-device-registrations/ 2025-08-01T07:08:23+00:00 https://globalregulatorypress.com/issue_articles/mexico-updated-lists-of-low-risk-medical-devices-and-health-products-not-considered-medical-devices/ 2025-08-01T07:08:24+00:00 https://globalregulatorypress.com/issue_articles/nigeria-feedback-sought-on-four-draft-african-standards/ 2025-08-01T07:08:25+00:00 https://globalregulatorypress.com/issue_articles/overview-of-the-regulatory-requirements-for-medical-devices-in-switzerland/ 2025-08-01T07:08:26+00:00 https://globalregulatorypress.com/issue_articles/philippines-guidelines-drafted-on-the-regulation-of-medical-device-software/ 2025-08-01T07:08:27+00:00 https://globalregulatorypress.com/issue_articles/portugal-exemption-from-presenting-information-in-portuguese-in-the-graphical-interfaces-of-medical-devices-for-professional-use/ 2025-08-01T07:08:29+00:00 https://globalregulatorypress.com/issue_articles/singapore-new-digital-portal-for-medical-devices-launched/ 2025-08-01T07:08:30+00:00 https://globalregulatorypress.com/issue_articles/singapore-proposed-exemption-from-licensing-and-registration-requirements-for-ai-samd-developed-by-certain-public-healthcare-entities-for-use-in-public-healthcare/ 2025-08-01T07:08:31+00:00 https://globalregulatorypress.com/issue_articles/singapore-revision-of-guidelines-on-risk-classification-of-samd-and-qualification-of-cdss/ 2025-08-01T07:08:32+00:00 https://globalregulatorypress.com/issue_articles/singapore-sixth-revision-of-change-notification-guidance-released/ 2025-08-01T07:08:33+00:00 https://globalregulatorypress.com/issue_articles/south-africa-iso-134852016-certificate-required-for-the-approval-of-a-medical-device-establishment-licence/ 2025-08-01T07:08:34+00:00 https://globalregulatorypress.com/issue_articles/south-africa-sahpra-joins-mdsap-as-an-affiliate-member/ 2025-08-01T07:08:36+00:00 https://globalregulatorypress.com/issue_articles/switzerland-federal-council-defines-guidelines-for-recognising-us-fda-approvals/ 2025-08-01T07:08:37+00:00 https://globalregulatorypress.com/issue_articles/switzerland-swiss-good-practice-for-the-reprocessing-of-medical-devices-in-outpatient-healthcare-facilities/ 2025-08-01T07:08:38+00:00 https://globalregulatorypress.com/issue_articles/uk-alignment-with-european-specifications-on-high-risk-ivds-to-reduce-regulatory-burden/ 2025-08-01T07:08:39+00:00 https://globalregulatorypress.com/issue_articles/uk-amended-fees-payable-to-the-mhra-from-16-july-2025/ 2025-08-01T07:08:40+00:00 https://globalregulatorypress.com/issue_articles/uk-change-to-standard-application-fee-for-registering-a-device-in-great-britain-2/ 2025-08-01T07:10:37+00:00 https://globalregulatorypress.com/issue_articles/uk-device-specific-vigilance-guidance-documents-issued/ 2025-08-01T07:10:38+00:00 https://globalregulatorypress.com/issue_articles/uk-digital-mental-health-technologies-guidance-updated/ 2025-08-01T07:10:40+00:00 https://globalregulatorypress.com/issue_articles/uk-new-pms-requirements-entered-into-force-in-june-2025/ 2025-08-01T07:10:41+00:00 https://globalregulatorypress.com/issue_articles/ukraine-new-rules-drafted-for-medical-devices-based-on-regulation-eu-2017-745/ 2025-08-01T07:10:42+00:00 https://globalregulatorypress.com/issue_articles/usa-answers-drafted-to-frequently-asked-questions-on-transfer-of-ownership-of-a-510k/ 2025-08-01T07:10:43+00:00 https://globalregulatorypress.com/issue_articles/usa-answers-to-frequently-asked-questions-on-use-of-remote-rras-provided-in-final-guidance/ 2025-08-01T07:10:44+00:00 https://globalregulatorypress.com/issue_articles/usa-breast-milk-macronutrients-test-system-classified-into-class-ii/ 2025-08-01T07:10:46+00:00 https://globalregulatorypress.com/issue_articles/usa-certain-class-ii-clinical-electronic-thermometers-are-now-exempt-from-510k-requirements/ 2025-08-01T07:10:47+00:00 https://globalregulatorypress.com/issue_articles/usa-class-ii-classification-and-special-controls-for-the-device-to-detect-and-identify-fungal-nucleic-acids-directly-in-respiratory-specimens/ 2025-08-01T07:10:48+00:00 https://globalregulatorypress.com/issue_articles/usa-class-ii-classification-for-the-device-to-detect-nucleic-acids-from-non-viral-microorganisms-causing-sexually-transmitted-infections-and-associated-resistance-markers/ 2025-08-01T07:10:49+00:00 https://globalregulatorypress.com/issue_articles/usa-class-ii-classification-for-the-dna-based-test-to-measure-minimal-residual-disease-in-haematological-malignancies/ 2025-08-01T07:10:50+00:00 https://globalregulatorypress.com/issue_articles/usa-class-ii-classification-for-the-hsv-nucleic-acid-based-assay-for-cns-infections/ 2025-08-01T07:10:51+00:00 https://globalregulatorypress.com/issue_articles/usa-class-ii-classification-for-the-plazomicin-test-system/ 2025-08-01T07:10:53+00:00 https://globalregulatorypress.com/issue_articles/usa-class-ii-classification-for-the-radiological-acquisition-and-or-optimisation-guidance-system/ 2025-08-01T07:10:54+00:00 https://globalregulatorypress.com/issue_articles/usa-class-ii-classification-for-the-temporarily-placed-urethral-opening-system-for-symptoms-of-benign-prostatic-hyperplasia/ 2025-08-01T07:10:55+00:00 https://globalregulatorypress.com/issue_articles/usa-class-ii-for-devices-to-detect-and-measure-non-microbial-analytes-to-aid-in-the-detection-and-identification-of-localised-human-infections/ 2025-08-01T07:10:56+00:00 https://globalregulatorypress.com/issue_articles/usa-class-ii-for-the-muscular-dystrophy-newborn-screening-test/ 2025-08-01T07:10:57+00:00 https://globalregulatorypress.com/issue_articles/usa-classification-of-the-cellular-analysis-system-for-multiplexed-antimicrobial-susceptibility-testing-into-class-ii/ 2025-08-01T07:10:58+00:00 https://globalregulatorypress.com/issue_articles/usa-clinical-mass-spectrometry-microorganism-identification-and-differentiation-system-classified-into-class-ii/ 2025-08-01T07:11:00+00:00 https://globalregulatorypress.com/issue_articles/usa-coagulation-system-for-the-measurement-of-whole-blood-viscoelastic-properties-in-perioperative-patients-classified-into-class-ii/ 2025-08-01T07:12:45+00:00 https://globalregulatorypress.com/issue_articles/usa-cream-for-x-ray-attenuation-classified-into-class-ii/ 2025-08-01T07:12:46+00:00 https://globalregulatorypress.com/issue_articles/usa-cytomegalovirus-nucleic-acid-detection-device-for-congenital-cytomegalovirus-infection-becomes-class-ii/ 2025-08-01T07:12:48+00:00 https://globalregulatorypress.com/issue_articles/usa-device-to-detect-bacterial-protease-activity-in-chronic-wound-fluid-becomes-class-ii/ 2025-08-01T07:12:49+00:00 https://globalregulatorypress.com/issue_articles/usa-draft-package-labelling-recommendations-for-hernia-mesh/ 2025-08-01T07:12:50+00:00 https://globalregulatorypress.com/issue_articles/usa-fda-classifies-the-anti-mullerian-hormone-test-system-into-class-ii/ 2025-08-01T07:12:51+00:00 https://globalregulatorypress.com/issue_articles/usa-fda-expands-use-of-unannounced-inspections-at-foreign-manufacturing-facilities/ 2025-08-01T07:12:52+00:00 https://globalregulatorypress.com/issue_articles/usa-fish-based-detection-of-chromosomal-abnormalities-from-patients-with-haematologic-malignancies-classified-into-class-ii/ 2025-08-01T07:12:53+00:00 https://globalregulatorypress.com/issue_articles/usa-guidance-documents-to-support-the-fdas-q-submission-process/ 2025-08-01T07:12:54+00:00 https://globalregulatorypress.com/issue_articles/usa-guidance-drafted-to-clarify-udi-requirements-for-combination-products/ 2025-08-01T07:12:56+00:00 https://globalregulatorypress.com/issue_articles/usa-inherited-nucleotide-repeat-disorder-dna-test-becomes-class-ii-with-special-controls/ 2025-08-01T07:12:57+00:00 https://globalregulatorypress.com/issue_articles/usa-lysosomal-storage-disorder-newborn-screening-test-system-becomes-class-ii/ 2025-08-01T07:12:58+00:00 https://globalregulatorypress.com/issue_articles/usa-medical-device-cybersecurity-quality-system-considerations-and-content-of-pre-market-submissions/ 2025-08-01T07:12:59+00:00 https://globalregulatorypress.com/issue_articles/usa-microbial-nucleic-acid-storage-and-stabilisation-device-becomes-class-ii/ 2025-08-01T07:13:00+00:00 https://globalregulatorypress.com/issue_articles/usa-modifications-to-the-list-of-fda-recognised-standards-2/ 2025-08-01T07:13:01+00:00 https://globalregulatorypress.com/issue_articles/usa-proposed-reclassification-of-ish-test-systems-indicated-for-use-with-a-corresponding-approved-oncology-therapeutic-product/ 2025-08-01T07:13:02+00:00 https://globalregulatorypress.com/issue_articles/usa-radiological-computer-assisted-detection-and-diagnosis-software-becomes-class-ii/ 2025-08-01T07:13:04+00:00 https://globalregulatorypress.com/issue_articles/usa-special-controls-set-for-device-to-detect-and-identify-microbial-nucleic-acids-by-fish-in-clinical-specimens/ 2025-08-01T07:13:05+00:00 https://globalregulatorypress.com/issue_articles/usa-upcoming-compliance-date-for-de-novo-submissions/ 2025-08-01T07:13:06+00:00 https://globalregulatorypress.com/issue_articles/usa-zika-virus-serological-reagents-have-been-classified-into-class-ii-special-controls/ 2025-08-01T07:13:07+00:00 https://globalregulatorypress.com/issue_articles/vietnam-fees-applicable-to-medical-devices-reduced-by-half/ 2025-08-01T07:13:40+00:00 https://globalregulatorypress.com/issue_articles/australia-advertising-permission-for-corrective-contact-lenses-and-spectacle-lenses/ 2025-10-31T08:09:44+00:00 https://globalregulatorypress.com/issue_articles/australia-complying-with-medical-device-cybersecurity-requirements/ 2025-10-31T08:09:46+00:00 https://globalregulatorypress.com/issue_articles/australia-guidance-documents-released-concerning-medical-device-application-audits/ 2025-10-31T08:09:47+00:00 https://globalregulatorypress.com/issue_articles/australia-guidance-on-the-regulatory-framework-for-ivd-cdx-and-for-the-medicine-or-biological-that-requires-cdx-testing/ 2025-10-31T08:09:48+00:00 https://globalregulatorypress.com/issue_articles/australia-guidance-released-to-clarify-when-digital-scribes-are-regulated-as-medical-devices/ 2025-10-31T08:09:49+00:00 https://globalregulatorypress.com/issue_articles/australia-tga-artificial-intelligence-review-report-now-published/ 2025-10-31T08:09:50+00:00 https://globalregulatorypress.com/issue_articles/australia-tga-seeks-input-on-digital-mental-health-tools/ 2025-10-31T08:09:52+00:00 https://globalregulatorypress.com/issue_articles/australia-updated-guidance-on-cdss-software/ 2025-10-31T08:09:53+00:00 https://globalregulatorypress.com/issue_articles/best-practices-for-obtaining-breakthrough-designation-using-the-us-fdas-breakthrough-devices-program/ 2025-10-31T08:09:54+00:00 https://globalregulatorypress.com/issue_articles/brazil-proposed-amendments-to-consolidated-conformity-assessment-requirements-for-breast-implants/ 2025-10-31T08:09:55+00:00 https://globalregulatorypress.com/issue_articles/canada-guidance-for-determining-medical-device-application-type/ 2025-10-31T08:09:56+00:00 https://globalregulatorypress.com/issue_articles/canada-second-estar-pilot-expands-scope-of-submission-types/ 2025-10-31T08:09:58+00:00 https://globalregulatorypress.com/issue_articles/chile-updated-conformity-standards-for-sterile-single-use-hypodermic-needles-and-syringes/ 2025-10-31T08:09:59+00:00 https://globalregulatorypress.com/issue_articles/china-guiding-principles-drafted-and-published/ 2025-10-31T08:10:00+00:00 https://globalregulatorypress.com/issue_articles/china-new-revised-and-abolished-medical-device-industry-standards/ 2025-10-31T08:10:01+00:00 https://globalregulatorypress.com/issue_articles/china-regulations-drafted-on-the-filing-and-management-of-internet-drug-and-medical-device-information-services/ 2025-10-31T08:10:03+00:00 https://globalregulatorypress.com/issue_articles/china-standards-drafted-on-wrought-stainless-steel-used-in-surgical-implants-and-optical-radiation-safety-for-ophthalmic-instruments/ 2025-10-31T08:10:04+00:00 https://globalregulatorypress.com/issue_articles/converging-regulations-the-eus-wfd-scip-reporting-the-espr-and-the-future-of-sustainable-medical-device-design/ 2025-10-31T08:10:05+00:00 https://globalregulatorypress.com/issue_articles/cybersecurity-in-the-usa-developing-a-nist-ssdf-based-profile-for-low-and-moderate-risk-medical-device-applications/ 2025-10-31T08:10:06+00:00 https://globalregulatorypress.com/issue_articles/denmark-danish-medicines-agency-expands-its-regulatory-advice-to-include-ai-act/ 2025-10-31T08:10:07+00:00 https://globalregulatorypress.com/issue_articles/ecuador-changes-to-rules-for-issuing-certificates-indicating-whether-or-not-a-sanitary-registration-notification-is-required-2/ 2025-10-31T08:13:14+00:00 https://globalregulatorypress.com/issue_articles/egypt-regulatory-guide-on-the-rules-and-procedures-for-the-import-and-export-of-non-commercial-samples/ 2025-10-31T08:13:15+00:00 https://globalregulatorypress.com/issue_articles/eu-additional-references-to-harmonised-standards-published-to-support-the-mdr/ 2025-10-31T08:13:16+00:00 https://globalregulatorypress.com/issue_articles/eu-first-revision-of-mdcg-2024-14-on-the-master-udi-di-solution-for-contact-lenses/ 2025-10-31T08:13:18+00:00 https://globalregulatorypress.com/issue_articles/eu-manual-on-borderline-and-classification-decisions-is-updated-3/ 2025-10-31T08:13:19+00:00 https://globalregulatorypress.com/issue_articles/eu-master-udi-to-apply-for-spectacle-frames-spectacle-lenses-and-ready-to-wear-reading-spectacles-2/ 2025-10-31T08:13:20+00:00 https://globalregulatorypress.com/issue_articles/eu-new-timetable-for-eudamed-implementation/ 2025-10-31T08:13:21+00:00 https://globalregulatorypress.com/issue_articles/eu-procedural-rules-for-joint-clinical-assessments-performed-under-health-technology-assessment-regulation/ 2025-10-31T08:13:22+00:00 https://globalregulatorypress.com/issue_articles/finland-fimea-strengthens-its-ai-expertise-in-the-supervision-of-medical-devices/ 2025-10-31T08:13:24+00:00 https://globalregulatorypress.com/issue_articles/finland-new-online-tool-helps-operators-assess-whether-they-are-covered-by-nis-2-cybersecurity-obligations/ 2025-10-31T08:13:25+00:00 https://globalregulatorypress.com/issue_articles/ghwp-public-consultation-held-on-several-proposed-documents/ 2025-10-31T08:13:26+00:00 https://globalregulatorypress.com/issue_articles/hong-kong-new-technical-reference-document-is-published-concerning-medical-device-software-and-cybersecurity/ 2025-10-31T08:13:27+00:00 https://globalregulatorypress.com/issue_articles/hong-kong-new-technical-reference-on-artificial-intelligence-in-medical-devices/ 2025-10-31T08:13:28+00:00 https://globalregulatorypress.com/issue_articles/hong-kong-updated-definition-of-adaptable-medical-device-in-guidance-gn-00/ 2025-10-31T08:13:30+00:00 https://globalregulatorypress.com/issue_articles/imdrf-comments-sought-on-essential-principles-and-content-of-pccps/ 2025-10-31T08:13:31+00:00 https://globalregulatorypress.com/issue_articles/india-comments-sought-on-draft-guidance-concerning-medical-device-software/ 2025-10-31T08:13:32+00:00 https://globalregulatorypress.com/issue_articles/india-standard-ivd-evaluation-protocols-published-by-icmr-and-cdsco/ 2025-10-31T08:13:33+00:00 https://globalregulatorypress.com/issue_articles/indonesia-version-6-of-the-electronic-catalogue-becomes-effective/ 2025-10-31T08:13:34+00:00 https://globalregulatorypress.com/issue_articles/ireland-proposed-medical-device-fees-for-2026/ 2025-10-31T08:13:35+00:00 https://globalregulatorypress.com/issue_articles/iso-new-version-of-iso-7405-for-the-biological-evaluation-of-dental-medical-devices/ 2025-10-31T08:13:37+00:00 https://globalregulatorypress.com/issue_articles/italy-new-fees-for-services-involving-medical-devices-and-ivds/ 2025-10-31T08:16:30+00:00 https://globalregulatorypress.com/issue_articles/japan-items-to-check-before-applying-for-a-general-medical-device-consultation/ 2025-10-31T08:16:31+00:00 https://globalregulatorypress.com/issue_articles/malaysia-fees-charged-for-the-registration-of-class-a-devices-to-change-from-1-january/ 2025-10-31T08:16:32+00:00 https://globalregulatorypress.com/issue_articles/malaysia-guidance-drafted-on-orphaned-medical-devices/ 2025-10-31T08:16:34+00:00 https://globalregulatorypress.com/issue_articles/malaysia-mda-becomes-affiliate-member-of-mdsap-and-now-accepts-mdsap-reports-and-certificates/ 2025-10-31T08:16:35+00:00 https://globalregulatorypress.com/issue_articles/malaysia-obsolete-and-discontinued-medical-devices-are-subject-of-new-draft-guidance/ 2025-10-31T08:16:36+00:00 https://globalregulatorypress.com/issue_articles/malaysia-proposed-updates-to-the-guidance-on-labelling-requirements-for-medical-devices/ 2025-10-31T08:16:37+00:00 https://globalregulatorypress.com/issue_articles/malaysia-revision-of-mda-gd-0068-on-conducting-conformity-assessment-by-way-of-verification-has-been-published/ 2025-10-31T08:16:39+00:00 https://globalregulatorypress.com/issue_articles/malaysia-second-edition-of-mda-gd-0070-establishment-guide-on-conformity-assessment-by-way-of-verification-has-been-released/ 2025-10-31T08:16:40+00:00 https://globalregulatorypress.com/issue_articles/malaysia-singapore-and-thailand-become-recognised-countries-for-conformity-assessment-purposes/ 2025-10-31T08:16:41+00:00 https://globalregulatorypress.com/issue_articles/navigating-udi-compliance-in-the-eu-practical-approaches-for-complex-and-special-device-categories/ 2025-10-31T08:16:42+00:00 https://globalregulatorypress.com/issue_articles/norway-consultation-on-changes-to-device-regulation/ 2025-10-31T08:16:43+00:00 https://globalregulatorypress.com/issue_articles/philippines-implementation-of-new-fees-and-charges-suspended-for-a-second-time/ 2025-10-31T08:16:45+00:00 https://globalregulatorypress.com/issue_articles/portugal-draft-financial-agreements-for-clinical-investigations-of-medical-devices/ 2025-10-31T08:16:46+00:00 https://globalregulatorypress.com/issue_articles/singapore-guidance-on-special-access-routes-has-been-updated/ 2025-10-31T08:16:47+00:00 https://globalregulatorypress.com/issue_articles/singapore-updated-guidance-on-laboratory-developed-tests/ 2025-10-31T08:16:49+00:00 https://globalregulatorypress.com/issue_articles/spain-collaboration-between-aemps-and-ceim-on-the-evaluation-of-clinical-investigations-and-performance-studies/ 2025-10-31T08:16:50+00:00 https://globalregulatorypress.com/issue_articles/spain-ministry-of-health-is-preparing-a-law-to-regulate-the-use-of-big-data-in-research-and-clinical-trials/ 2025-10-31T08:16:51+00:00 https://globalregulatorypress.com/issue_articles/spotlight-on-recent-regulatory-changes-in-south-africa/ 2025-10-31T08:16:52+00:00 https://globalregulatorypress.com/issue_articles/switzerland-implementation-of-the-eu-requirements-for-the-electronic-provision-of-instructions-for-use/ 2025-10-31T08:16:53+00:00 https://globalregulatorypress.com/issue_articles/switzerland-new-udi-devices-module-in-swissdamed-is-live/ 2025-10-31T08:19:11+00:00 https://globalregulatorypress.com/issue_articles/taiwan-updated-guidelines-on-artificial-intelligence-machine-learning-medical-devices/ 2025-10-31T08:19:12+00:00 https://globalregulatorypress.com/issue_articles/thailand-adverts-at-exhibitions-and-conferences-do-not-require-prior-permission/ 2025-10-31T08:19:14+00:00 https://globalregulatorypress.com/issue_articles/thailand-certain-documents-do-not-need-to-be-submitted-for-medical-device-licence-or-notification-renewals/ 2025-10-31T08:19:15+00:00 https://globalregulatorypress.com/issue_articles/thailand-preparing-and-maintaining-records-and-reports-on-the-production-import-or-sale-of-medical-devices/ 2025-10-31T08:19:16+00:00 https://globalregulatorypress.com/issue_articles/the-eu-data-act-how-manufacturers-lose-control-over-connected-device-data/ 2025-10-31T08:19:17+00:00 https://globalregulatorypress.com/issue_articles/uk-new-annual-fee-and-updated-fee-structure-to-apply-from-1-april-2026/ 2025-10-31T08:19:18+00:00 https://globalregulatorypress.com/issue_articles/uk-new-guidance-on-clinical-trials-that-include-an-ivd/ 2025-10-31T08:19:20+00:00 https://globalregulatorypress.com/issue_articles/uk-standardised-format-for-a-post-market-surveillance-report/ 2025-10-31T08:19:21+00:00 https://globalregulatorypress.com/issue_articles/uk-updated-guidance-on-clinical-investigations-for-medical-devices/ 2025-10-31T08:19:22+00:00 https://globalregulatorypress.com/issue_articles/ukraine-technical-regulation-on-medical-devices-to-be-updated/ 2025-10-31T08:19:23+00:00 https://globalregulatorypress.com/issue_articles/usa-class-ii-special-controls-classifications-made-by-the-fda/ 2025-10-31T08:19:24+00:00 https://globalregulatorypress.com/issue_articles/usa-consideration-of-enforcement-policies-for-ivd-tests-during-a-section-564-declared-emergency/ 2025-10-31T08:19:26+00:00 https://globalregulatorypress.com/issue_articles/usa-fda-medical-device-user-fees-for-fiscal-year-2026/ 2025-10-31T08:19:27+00:00 https://globalregulatorypress.com/issue_articles/usa-final-guidance-issued-on-animal-studies-for-dental-bone-grafting-material-devices/ 2025-10-31T08:19:28+00:00 https://globalregulatorypress.com/issue_articles/usa-guidance-issued-on-the-medical-device-user-fee-small-business-qualification-and-determination/ 2025-10-31T08:19:29+00:00 https://globalregulatorypress.com/issue_articles/usa-guidance-released-on-computer-software-assurance-for-production-and-quality-system-software/ 2025-10-31T08:19:30+00:00 https://globalregulatorypress.com/issue_articles/usa-input-sought-on-measuring-and-evaluating-real-world-performance-of-ai-enabled-medical-devices/ 2025-10-31T08:19:32+00:00 https://globalregulatorypress.com/issue_articles/usa-white-paper-addresses-critical-outage-situations-and-response-to-ensure-medical-imaging-device-cybersecurity/ 2025-10-31T08:19:33+00:00 https://globalregulatorypress.com/issue_articles/an-overview-of-the-medical-device-regulations-in-jordan/ 2026-01-30T09:57:47+00:00 https://globalregulatorypress.com/issue_articles/argentina-new-decree-simplifies-technical-approval-for-importing-products/ 2026-01-30T09:57:48+00:00 https://globalregulatorypress.com/issue_articles/argentina-simplified-process-for-authorising-establishments-that-manufacture-and-or-import-low-risk-medical-products/ 2026-01-30T09:57:50+00:00 https://globalregulatorypress.com/issue_articles/australia-consultation-held-on-udi-consent-to-supply-approach-and-fees/ 2026-01-30T09:57:51+00:00 https://globalregulatorypress.com/issue_articles/australia-consultation-on-proposed-amendments-to-improve-transparency-of-device-supply-disruptions/ 2026-01-30T09:57:52+00:00 https://globalregulatorypress.com/issue_articles/australia-essential-principles-guidance-updated-to-include-information-on-principle-13/ 2026-01-30T09:57:53+00:00 https://globalregulatorypress.com/issue_articles/australia-key-changes-regarding-artg-inclusion-applications/ 2026-01-30T09:57:54+00:00 https://globalregulatorypress.com/issue_articles/australia-proposed-changes-to-medical-device-conformity-assessment-procedures/ 2026-01-30T09:57:55+00:00 https://globalregulatorypress.com/issue_articles/australia-updated-guidance-on-advertising-therapeutic-goods-on-social-media/ 2026-01-30T09:57:56+00:00 https://globalregulatorypress.com/issue_articles/brazil-anvisa-launches-new-tool-for-issuing-medical-device-certificates/ 2026-01-30T09:57:58+00:00 https://globalregulatorypress.com/issue_articles/brazil-anvisa-publishes-new-version-of-manual-for-the-registration-of-medical-equipment-and-samd/ 2026-01-30T09:57:59+00:00 https://globalregulatorypress.com/issue_articles/brazil-anvisa-unifies-subject-codes-for-cbpf-applications-for-medical-devices/ 2026-01-30T09:58:00+00:00 https://globalregulatorypress.com/issue_articles/brazil-anvisa-updates-manual-for-registration-of-healthcare-materials/ 2026-01-30T09:58:01+00:00 https://globalregulatorypress.com/issue_articles/brazil-saline-solutions-for-nasal-irrigation-become-medical-devices/ 2026-01-30T09:58:02+00:00 https://globalregulatorypress.com/issue_articles/canada-advice-published-on-device-licence-applications-for-diagnostic-ultrasound-systems-and-transducers/ 2026-01-30T09:58:03+00:00 https://globalregulatorypress.com/issue_articles/canada-health-canada-aligns-medical-device-submissions-with-global-standards/ 2026-01-30T09:58:04+00:00 https://globalregulatorypress.com/issue_articles/canada-proposed-changes-to-the-rules-covering-establishment-licensing/ 2026-01-30T09:58:05+00:00 https://globalregulatorypress.com/issue_articles/canada-revised-fees-for-medical-device-applications-become-effective-on-1-april-2026/ 2026-01-30T09:58:07+00:00 https://globalregulatorypress.com/issue_articles/canada-updated-guidance-on-managing-applications-for-medical-device-licences/ 2026-01-30T09:58:08+00:00 https://globalregulatorypress.com/issue_articles/china-2025-edition-of-catalogue-of-high-end-medical-devices-priority-for-approval-published/ 2026-01-30T09:58:09+00:00 https://globalregulatorypress.com/issue_articles/china-changes-to-the-medical-device-classification-catalogue/ 2026-01-30T10:02:04+00:00 https://globalregulatorypress.com/issue_articles/china-guiding-principles-and-key-points-drafted-and-published/ 2026-01-30T10:02:05+00:00 https://globalregulatorypress.com/issue_articles/china-new-and-revised-medical-device-industry-standards-2/ 2026-01-30T10:02:06+00:00 https://globalregulatorypress.com/issue_articles/china-revised-good-manufacturing-practice-for-medical-devices-has-been-released/ 2026-01-30T10:02:07+00:00 https://globalregulatorypress.com/issue_articles/china-standard-on-roller-blood-pumps-circulated-for-comment/ 2026-01-30T10:02:08+00:00 https://globalregulatorypress.com/issue_articles/china-two-recommended-medical-device-industry-standards-to-be-developed/ 2026-01-30T10:02:09+00:00 https://globalregulatorypress.com/issue_articles/china-updated-regulations-on-the-administration-of-medical-device-export-sales-certificates/ 2026-01-30T10:02:10+00:00 https://globalregulatorypress.com/issue_articles/clarifying-the-role-of-equivalence-and-similarity-in-medical-device-conformity-assessment-under-the-mdr/ 2026-01-30T10:02:12+00:00 https://globalregulatorypress.com/issue_articles/denmark-new-guide-to-using-influencer-marketing-for-medical-devices-in-denmark/ 2026-01-30T10:02:13+00:00 https://globalregulatorypress.com/issue_articles/ecuador-changes-to-rules-for-issuing-certificates-indicating-whether-or-not-a-sanitary-registration-notification-is-required-3/ 2026-01-30T10:02:14+00:00 https://globalregulatorypress.com/issue_articles/egypt-basic-requirements-for-accepting-import-approval-requests-via-medevice/ 2026-01-30T10:02:15+00:00 https://globalregulatorypress.com/issue_articles/egypt-formal-adoption-of-es-5526-3/ 2026-01-30T10:02:16+00:00 https://globalregulatorypress.com/issue_articles/egypt-import-approvals-for-refurbished-spare-parts-for-medical-and-laboratory-equipment/ 2026-01-30T10:02:17+00:00 https://globalregulatorypress.com/issue_articles/eu-commission-proposes-simplification-of-the-medical-devices-regulations/ 2026-01-30T10:02:18+00:00 https://globalregulatorypress.com/issue_articles/eu-first-four-eudamed-modules-officially-declared-functional/ 2026-01-30T10:02:20+00:00 https://globalregulatorypress.com/issue_articles/eu-first-revision-of-mdcg-2025-7-reflects-full-functionality-of-certain-eudamed-modules/ 2026-01-30T10:02:21+00:00 https://globalregulatorypress.com/issue_articles/eu-guidance-on-breakthrough-devices-published-as-mdcg-2025-9/ 2026-01-30T10:02:22+00:00 https://globalregulatorypress.com/issue_articles/eu-new-mdcg-guidance-on-pms-requirements/ 2026-01-30T10:02:23+00:00 https://globalregulatorypress.com/issue_articles/eu-pilot-coordinated-assessment-of-clinical-investigations-and-performance-studies/ 2026-01-30T10:02:24+00:00 https://globalregulatorypress.com/issue_articles/eu-publication-of-mdcg-2025-8-on-master-udi-dis-for-spectacle-frames-spectacle-lenses-and-ready-to-wear-reading-spectacles/ 2026-01-30T10:02:25+00:00 https://globalregulatorypress.com/issue_articles/evolution-of-the-biological-evaluation-of-medical-devices-to-iso-10993-12025/ 2026-01-30T10:05:01+00:00 https://globalregulatorypress.com/issue_articles/finland-fimea-publishes-guidance-on-the-use-of-artificial-intelligence-in-medical-devices/ 2026-01-30T10:05:02+00:00 https://globalregulatorypress.com/issue_articles/finland-infographic-created-to-support-clinical-trial-design/ 2026-01-30T10:05:03+00:00 https://globalregulatorypress.com/issue_articles/finland-regulatory-guidance-for-manufacturers-of-custom-made-medical-devices/ 2026-01-30T10:05:04+00:00 https://globalregulatorypress.com/issue_articles/france-optimisation-of-the-application-process-for-exceptional-access-for-an-ivd-without-a-ce-marking/ 2026-01-30T10:05:05+00:00 https://globalregulatorypress.com/issue_articles/france-procedures-established-for-quality-control-of-ct-scanners/ 2026-01-30T10:05:07+00:00 https://globalregulatorypress.com/issue_articles/ghwp-documents-endorsed-at-29th-ghwp-meeting/ 2026-01-30T10:05:08+00:00 https://globalregulatorypress.com/issue_articles/hong-kong-guidances-gn-00-gn-01-gn-07-gn-08-and-gn-09-have-been-updated/ 2026-01-30T10:05:09+00:00 https://globalregulatorypress.com/issue_articles/how-to-prepare-a-beneficial-and-efficient-pms-report/ 2026-01-30T10:05:10+00:00 https://globalregulatorypress.com/issue_articles/india-medtech-mitras-in-vitro-diagnostic-innovators-handbook/ 2026-01-30T10:05:11+00:00 https://globalregulatorypress.com/issue_articles/india-draft-regulatory-amendments-could-see-licences-and-registrations-remain-valid-indefinitely/ 2026-01-30T10:05:12+00:00 https://globalregulatorypress.com/issue_articles/india-packaging-rules-for-medical-devices-are-simplified/ 2026-01-30T10:05:14+00:00 https://globalregulatorypress.com/issue_articles/india-published-updates-to-existing-risk-based-classification-lists/ 2026-01-30T10:05:15+00:00 https://globalregulatorypress.com/issue_articles/indonesia-procedures-for-implementing-foreign-halal-certificate-registration/ 2026-01-30T10:05:16+00:00 https://globalregulatorypress.com/issue_articles/iso-standard-on-testing-of-ai-systems/ 2026-01-30T10:05:17+00:00 https://globalregulatorypress.com/issue_articles/japan-draft-review-points-for-home-use-medical-devices-that-detect-signs-of-illness-and-encourage-medical-consultations/ 2026-01-30T10:05:18+00:00 https://globalregulatorypress.com/issue_articles/japan-usa-designated-as-an-equivalent-regulatory-authority/ 2026-01-30T10:05:19+00:00 https://globalregulatorypress.com/issue_articles/levels-of-autonomy-in-medical-ai-implications-for-risk-regulation-and-clinical-practice/ 2026-01-30T10:05:20+00:00 https://globalregulatorypress.com/issue_articles/malaysia-medical-device-designated-medical-device-order-2026/ 2026-01-30T10:05:22+00:00 https://globalregulatorypress.com/issue_articles/malaysia-comments-sought-on-updated-guidance-concerning-the-definition-of-a-medical-device/ 2026-01-30T10:05:23+00:00 https://globalregulatorypress.com/issue_articles/malaysia-consultation-held-on-change-management-guidance-for-registered-medical-devices/ 2026-01-30T10:07:40+00:00 https://globalregulatorypress.com/issue_articles/malaysia-delayed-enforcement-of-medical-device-import-permit-process/ 2026-01-30T10:07:41+00:00 https://globalregulatorypress.com/issue_articles/malaysia-validity-periods-for-product-classification-letters/ 2026-01-30T10:07:41+00:00 https://globalregulatorypress.com/issue_articles/mexico-cofepris-publishes-interpretive-guidance-on-gmp-standard-nom-241-ssa1-2025/ 2026-01-30T10:07:43+00:00 https://globalregulatorypress.com/issue_articles/panama-comments-sought-on-proposed-executive-decree-to-regulate-law-no-90-2017-on-medical-devices-and-ivds/ 2026-01-30T10:07:44+00:00 https://globalregulatorypress.com/issue_articles/philippines-draft-guidelines-on-the-inspection-of-medical-device-establishments/ 2026-01-30T10:07:45+00:00 https://globalregulatorypress.com/issue_articles/philippines-guidelines-drafted-on-the-qualification-criteria-for-grouping-medical-devices-for-product-registration/ 2026-01-30T10:07:46+00:00 https://globalregulatorypress.com/issue_articles/philippines-guidelines-on-using-the-eservices-portal-system-for-initial-cmdn-applications/ 2026-01-30T10:07:47+00:00 https://globalregulatorypress.com/issue_articles/portugal-new-law-strengthens-rules-for-clinical-research-and-performance-studies/ 2026-01-30T10:07:48+00:00 https://globalregulatorypress.com/issue_articles/singapore-revision-of-guidance-documents/ 2026-01-30T10:07:49+00:00 https://globalregulatorypress.com/issue_articles/south-africa-comments-sought-on-guideline-for-licence-applications-for-non-ionising-radiation-devices-classified-as-listed-electronic-products/ 2026-01-30T10:07:51+00:00 https://globalregulatorypress.com/issue_articles/south-africa-fourth-revision-of-guideline-for-donation-of-medicines-medical-devices-and-ivds/ 2026-01-30T10:07:52+00:00 https://globalregulatorypress.com/issue_articles/south-africa-guidance-drafted-on-applying-for-a-cfs-for-a-medical-device-ivd/ 2026-01-30T10:07:53+00:00 https://globalregulatorypress.com/issue_articles/south-africa-guidance-drafted-on-applying-for-a-licence-to-install-use-and-operate-mri-equipment/ 2026-01-30T10:07:54+00:00 https://globalregulatorypress.com/issue_articles/south-africa-guidance-published-on-importation-and-use-of-ultra-portable-x-ray-equipment/ 2026-01-30T10:07:55+00:00 https://globalregulatorypress.com/issue_articles/south-africa-guidance-released-on-regulatory-reliance-pathway/ 2026-01-30T10:07:56+00:00 https://globalregulatorypress.com/issue_articles/spain-council-of-ministers-approves-new-royal-decree-on-ivds/ 2026-01-30T10:07:57+00:00 https://globalregulatorypress.com/issue_articles/sweden-creation-of-dedicated-medical-technology-business-area/ 2026-01-30T10:07:58+00:00 https://globalregulatorypress.com/issue_articles/switzerland-deadline-for-product-registration-in-swissdamed/ 2026-01-30T10:08:00+00:00 https://globalregulatorypress.com/issue_articles/uk-deliverables-and-timelines-to-support-the-development-of-safe-ivds-set-out-in-roadmap/ 2026-01-30T10:08:01+00:00 https://globalregulatorypress.com/issue_articles/uk-guidance-released-on-mhra-regulatory-advice-meetings/ 2026-01-30T10:09:49+00:00 https://globalregulatorypress.com/issue_articles/uk-updated-guidance-on-gaining-approval-of-a-clinical-trial-that-includes-an-ivd/ 2026-01-30T10:09:50+00:00 https://globalregulatorypress.com/issue_articles/uk-updated-guidance-on-notifying-the-mhra-of-an-intention-to-conduct-a-clinical-investigation/ 2026-01-30T10:09:52+00:00 https://globalregulatorypress.com/issue_articles/ukraine-guidelines-published-on-hta-of-medical-devices/ 2026-01-30T10:09:53+00:00 https://globalregulatorypress.com/issue_articles/usa-class-ii-classification-for-the-anchored-oesophageal-sheath/ 2026-01-30T10:09:54+00:00 https://globalregulatorypress.com/issue_articles/usa-comments-sought-on-draft-guidance-on-cuffless-non-invasive-blood-pressure-devices/ 2026-01-30T10:09:55+00:00 https://globalregulatorypress.com/issue_articles/usa-comments-sought-on-petition-for-partial-510k-exemption-for-certain-radiology-software-devices/ 2026-01-30T10:09:56+00:00 https://globalregulatorypress.com/issue_articles/usa-electrical-tongue-nerve-stimulator-to-treat-motor-deficits-classified-into-class-ii/ 2026-01-30T10:09:57+00:00 https://globalregulatorypress.com/issue_articles/usa-field-generator-positioning-devices-become-class-i-general-controls/ 2026-01-30T10:09:58+00:00 https://globalregulatorypress.com/issue_articles/usa-guidance-drafted-on-qms-information-for-certain-pre-market-submission-reviews/ 2026-01-30T10:10:00+00:00 https://globalregulatorypress.com/issue_articles/usa-guidance-issued-on-use-of-rwe-to-support-regulatory-decision-making/ 2026-01-30T10:10:01+00:00 https://globalregulatorypress.com/issue_articles/usa-guidance-sets-out-compliance-policy-for-low-risk-general-wellness-products/ 2026-01-30T10:10:02+00:00 https://globalregulatorypress.com/issue_articles/usa-guidance-updated-on-clinical-decision-support-software/ 2026-01-30T10:10:03+00:00 https://globalregulatorypress.com/issue_articles/usa-human-factors-engineering-standard-updated-for-first-time-since-2009/ 2026-01-30T10:10:04+00:00 https://globalregulatorypress.com/issue_articles/usa-proposed-down-classification-of-nucleic-acid-based-test-systems-indicated-for-use-with-a-corresponding-approved-oncology-therapeutic-product/ 2026-01-30T10:10:05+00:00 https://globalregulatorypress.com/issue_articles/usa-safety-reporting-for-investigational-drugs-and-devices-subject-of-new-final-guidance/ 2026-01-30T10:10:06+00:00 https://globalregulatorypress.com/issue_articles/usa-technical-amendment-issued-to-quality-management-system-regulation/ 2026-01-30T10:10:07+00:00 https://globalregulatorypress.com/issue_articles/usa-updated-performance-testing-and-labelling-recommendations-drafted-for-menstrual-products/ 2026-01-30T10:10:09+00:00 https://globalregulatorypress.com/issue_articles/aligning-the-ai-act-and-the-mdr-ivdr-what-the-ai-act-simplification-proposal-means-for-ai-enabled-medical-devices/ 2026-04-30T09:15:03+00:00 https://globalregulatorypress.com/issue_articles/an-updated-overview-of-the-regulatory-requirements-for-medical-devices-including-in-vitro-diagnostic-medical-devices-in-cuba/ 2026-04-30T09:31:43+00:00 https://globalregulatorypress.com/issue_articles/analysis-of-the-european-commissions-proposal-for-the-revision-of-the-mdr-and-ivdr/ 2026-04-30T09:31:45+00:00 https://globalregulatorypress.com/issue_articles/argentina-anmat-facilitates-the-import-of-used-medical-equipment/ 2026-04-30T09:31:45+00:00 https://globalregulatorypress.com/issue_articles/argentina-simplified-registration-procedure-for-the-importation-and-marketing-of-certain-medical-devices/ 2026-04-30T09:31:45+00:00 https://globalregulatorypress.com/issue_articles/brazil-requirements-for-transmission-to-and-management-of-the-udi-database/ 2026-04-30T09:31:45+00:00 https://globalregulatorypress.com/issue_articles/australia-guidance-documents-published-on-software-based-medical-device-exclusions/ 2026-04-30T09:31:45+00:00 https://globalregulatorypress.com/issue_articles/canada-health-canada-issues-new-guidance-on-post-market-monitoring-of-medical-devices/ 2026-04-30T09:31:46+00:00 https://globalregulatorypress.com/issue_articles/canada-pre-market-guidance-for-machine-learning-medical-devices-has-been-updated/ 2026-04-30T09:31:46+00:00 https://globalregulatorypress.com/issue_articles/canada-significant-change-for-medical-devices-subject-of-updated-guidance/ 2026-04-30T09:31:46+00:00 https://globalregulatorypress.com/issue_articles/canada-updated-classification-of-covid-19-testing-devices/ 2026-04-30T09:31:46+00:00 https://globalregulatorypress.com/issue_articles/canada-updated-guidance-issued-on-use-of-terms-and-conditions-for-device-licences/ 2026-04-30T09:31:47+00:00 https://globalregulatorypress.com/issue_articles/canada-updated-guidance-on-clinical-evidence-requirements-for-medical-devices/ 2026-04-30T09:31:47+00:00 https://globalregulatorypress.com/issue_articles/canada-use-of-regulatory-enrolment-process-mandatory-for-medical-devices/ 2026-04-30T09:31:47+00:00 https://globalregulatorypress.com/issue_articles/china-new-guiding-principles-released/ 2026-04-30T09:31:47+00:00 https://globalregulatorypress.com/issue_articles/colombia-reporting-on-nomenclature-and-coding-is-now-mandatory-for-marketing/ 2026-04-30T09:31:48+00:00 https://globalregulatorypress.com/issue_articles/china-updates-on-udi-implementation-timeframes-exemptions-and-special-rules/ 2026-04-30T09:31:48+00:00 https://globalregulatorypress.com/issue_articles/china-pre-review-of-innovative-medical-device-clinical-trial-protocols/ 2026-04-30T09:31:48+00:00 https://globalregulatorypress.com/issue_articles/china-repealed-new-revised-and-draft-medical-device-industry-standards/ 2026-04-30T09:31:48+00:00 https://globalregulatorypress.com/issue_articles/egypt-country-of-origin-verification-requirements-for-ce-certified-products/ 2026-04-30T09:31:48+00:00 https://globalregulatorypress.com/issue_articles/egypt-clarification-provided-for-local-manufacturers-holding-international-quality-certificates/ 2026-04-30T09:31:48+00:00 https://globalregulatorypress.com/issue_articles/egypt-eda-facilitates-certain-medical-device-registration-procedures/ 2026-04-30T09:42:42+00:00 https://globalregulatorypress.com/issue_articles/egypt-procedures-to-be-followed-by-companies-relying-on-eu-mdr-certification/ 2026-04-30T09:42:43+00:00 https://globalregulatorypress.com/issue_articles/eu-additional-references-to-harmonised-standards-published-to-support-the-mdr-ivdr-7/ 2026-04-30T09:42:44+00:00 https://globalregulatorypress.com/issue_articles/eu-expansion-of-the-list-of-well-established-technologies/ 2026-04-30T09:42:44+00:00 https://globalregulatorypress.com/issue_articles/eu-decision-tree-supports-assessment-of-interruption-or-discontinuation-of-supply/ 2026-04-30T09:42:44+00:00 https://globalregulatorypress.com/issue_articles/eu-mdcg-2021-24-guidance-on-classification-of-medical-devices-has-been-revised/ 2026-04-30T09:42:44+00:00 https://globalregulatorypress.com/issue_articles/eu-first-revision-of-guidance-on-implementation-of-the-master-udi-di-solution-for-spectacle-frames-spectacle-lenses-and-ready-to-wear-reading-spectacles/ 2026-04-30T09:42:44+00:00 https://globalregulatorypress.com/issue_articles/eu-manual-on-borderline-and-classification-decisions-updated/ 2026-04-30T09:42:44+00:00 https://globalregulatorypress.com/issue_articles/eu-new-standard-for-the-safety-of-non-laser-light-source-equipment-used-in-medical-and-aesthetic-applications/ 2026-04-30T09:42:44+00:00 https://globalregulatorypress.com/issue_articles/eu-use-of-four-eudamed-modules-to-become-mandatory-in-may-2026/ 2026-04-30T09:42:45+00:00 https://globalregulatorypress.com/issue_articles/eu-use-of-updated-mir-form-becomes-mandatory-on-1-may-2026/ 2026-04-30T09:42:45+00:00 https://globalregulatorypress.com/issue_articles/eu-updates-to-the-european-medical-device-nomenclature/ 2026-04-30T09:42:45+00:00 https://globalregulatorypress.com/issue_articles/eu-pilot-programme-on-expert-panel-support-for-breakthrough-medical-devices/ 2026-04-30T09:42:45+00:00 https://globalregulatorypress.com/issue_articles/finland-fimea-publishes-clinical-investigation-plan-template/ 2026-04-30T09:42:45+00:00 https://globalregulatorypress.com/issue_articles/france-medical-devices-for-individual-use-that-may-be-restored-to-good-working-order/ 2026-04-30T09:42:45+00:00 https://globalregulatorypress.com/issue_articles/germany-directory-for-interoperable-interfaces-of-assistive-devices-and-implants/ 2026-04-30T09:42:45+00:00 https://globalregulatorypress.com/issue_articles/hong-kong-medical-device-software-cybersecurity-and-artificial-intelligence/ 2026-04-30T09:42:45+00:00 https://globalregulatorypress.com/issue_articles/imdrf-playbook-for-medical-device-regulatory-reliance-programs/ 2026-04-30T09:42:46+00:00 https://globalregulatorypress.com/issue_articles/imdrf-draft-technical-framework-for-ai-lifecycle-management/ 2026-04-30T09:42:46+00:00 https://globalregulatorypress.com/issue_articles/hong-kong-new-technical-guidance-released-on-combination-products/ 2026-04-30T09:42:46+00:00 https://globalregulatorypress.com/issue_articles/imdrf-guidance-drafted-on-clinical-evidence-requirements-for-ivds/ 2026-04-30T09:46:04+00:00 https://globalregulatorypress.com/issue_articles/imdrf-updated-terminologies-for-categorised-adverse-event-reporting/ 2026-04-30T09:46:06+00:00 https://globalregulatorypress.com/issue_articles/iso-second-edition-of-iso-20417-on-information-to-be-supplied-by-the-manufacturer/ 2026-04-30T09:46:06+00:00 https://globalregulatorypress.com/issue_articles/iso-updates-published-for-iso-14155-on-clinical-investigations-of-medical-devices/ 2026-04-30T09:46:06+00:00 https://globalregulatorypress.com/issue_articles/iso-new-standard-in-development-on-cleanliness-of-medical-devices-after-production/ 2026-04-30T09:46:06+00:00 https://globalregulatorypress.com/issue_articles/india-proposed-fees-for-tests-or-evaluations/ 2026-04-30T09:46:06+00:00 https://globalregulatorypress.com/issue_articles/india-draft-guidance-for-cdsco-import-licence-applications/ 2026-04-30T09:46:06+00:00 https://globalregulatorypress.com/issue_articles/india-frequently-asked-questions-on-in-vitro-diagnostics-have-been-updated/ 2026-04-30T09:46:06+00:00 https://globalregulatorypress.com/issue_articles/malaysia-approval-issued-by-hsa-permitted-by-mda-for-conformity-assessments-via-verification-process/ 2026-04-30T09:46:07+00:00 https://globalregulatorypress.com/issue_articles/malaysia-implementation-of-the-innovative-medical-device-review-pathway/ 2026-04-30T09:46:07+00:00 https://globalregulatorypress.com/issue_articles/malaysia-licensing-requirements-and-temporary-exemptions-for-medical-device-tenderers/ 2026-04-30T09:46:07+00:00 https://globalregulatorypress.com/issue_articles/malaysia-issuance-of-electronic-certificates/ 2026-04-30T09:46:07+00:00 https://globalregulatorypress.com/issue_articles/malaysia-guidance-issued-for-obsolete-and-discontinued-medical-devices/ 2026-04-30T09:46:07+00:00 https://globalregulatorypress.com/issue_articles/israel-mandatory-testing-according-to-revised-version-of-si-60601-1-from-8-february-2027/ 2026-04-30T09:46:07+00:00 https://globalregulatorypress.com/issue_articles/korea-republic-of-medical-device-gmp-regulations-available-in-english/ 2026-04-30T09:46:07+00:00 https://globalregulatorypress.com/issue_articles/malaysia-mda-able-to-participate-in-collaborative-registration-procedure-for-who-prequalified-ivds/ 2026-04-30T09:46:08+00:00 https://globalregulatorypress.com/issue_articles/malaysia-updated-guidance-covers-electronic-labelling-of-home-use-medical-devices/ 2026-04-30T09:46:08+00:00 https://globalregulatorypress.com/issue_articles/malaysia-new-medical-device-definitions-included-in-revised-guidance/ 2026-04-30T09:46:08+00:00 https://globalregulatorypress.com/issue_articles/malaysia-third-revision-of-guidance-on-special-access-exemption-scheme/ 2026-04-30T09:46:08+00:00 https://globalregulatorypress.com/issue_articles/malaysia-mda-gd-0066-has-been-withdrawn/ 2026-04-30T09:46:08+00:00 https://globalregulatorypress.com/issue_articles/nordic-consultation-held-on-environmental-criteria-for-plastic-and-silicone-medical-devices/ 2026-04-30T09:48:57+00:00 https://globalregulatorypress.com/issue_articles/philippines-comments-sought-on-guidance-for-good-storage-and-distribution-practices/ 2026-04-30T09:48:59+00:00 https://globalregulatorypress.com/issue_articles/philippines-guidelines-drafted-on-the-maintenance-of-importation-distribution-records-and-the-reporting-of-product-complaints-adverse-events-field-safety-corrective-actions/ 2026-04-30T09:48:59+00:00 https://globalregulatorypress.com/issue_articles/south-africa-amendment-of-a-medical-device-establishment-licence/ 2026-04-30T09:48:59+00:00 https://globalregulatorypress.com/issue_articles/south-africa-establishment-licensing-requirements-for-outsourced-or-contracted-activities/ 2026-04-30T09:48:59+00:00 https://globalregulatorypress.com/issue_articles/south-africa-guidance-issued-on-obtaining-a-certificate-of-free-sale/ 2026-04-30T09:49:00+00:00 https://globalregulatorypress.com/issue_articles/south-africa-guidance-released-on-regulatory-reliance-pathway-2/ 2026-04-30T09:49:00+00:00 https://globalregulatorypress.com/issue_articles/south-africa-guidance-on-licence-applications-for-non-ionising-radiation-medical-devices-classified-as-listed-electronic-products/ 2026-04-30T09:49:00+00:00 https://globalregulatorypress.com/issue_articles/sufficient-clinical-evidence-for-medical-devices-what-is-the-role-of-post-market-real-world-data/ 2026-04-30T09:49:00+00:00 https://globalregulatorypress.com/issue_articles/spotlight-on-recent-regulatory-changes-in-uzbekistan/ 2026-04-30T09:49:00+00:00 https://globalregulatorypress.com/issue_articles/sweden-new-version-of-the-medical-products-agencys-ai-guidance-for-healthcare/ 2026-04-30T09:49:00+00:00 https://globalregulatorypress.com/issue_articles/thailand-guidance-updated-on-change-notifications/ 2026-04-30T09:49:01+00:00 https://globalregulatorypress.com/issue_articles/thailand-proposed-revision-to-rules-for-conducting-clinical-investigations/ 2026-04-30T09:49:01+00:00 https://globalregulatorypress.com/issue_articles/switzerland-broad-package-of-eu-switzerland-agreements-signed/ 2026-04-30T09:49:01+00:00 https://globalregulatorypress.com/issue_articles/switzerland-registration-of-legacy-devices-now-possible-in-swissdamed/ 2026-04-30T09:49:01+00:00 https://globalregulatorypress.com/issue_articles/switzerland-product-registration-in-swissdamed-to-become-mandatory-on-1-july-2026/ 2026-04-30T09:49:01+00:00 https://globalregulatorypress.com/issue_articles/switzerland-swiss-good-practice-for-the-maintenance-of-medical-devices-has-been-updated/ 2026-04-30T09:49:01+00:00 https://globalregulatorypress.com/issue_articles/uk-annual-registration-fee-charged-per-level-2-gmdn-category/ 2026-04-30T09:49:02+00:00 https://globalregulatorypress.com/issue_articles/uk-consultation-on-proposals-for-indefinite-recognition-of-ce-marked-medical-devices-in-great-britain/ 2026-04-30T09:49:02+00:00 https://globalregulatorypress.com/issue_articles/uk-guidance-on-medical-device-clinical-investigations/ 2026-04-30T09:49:02+00:00 https://globalregulatorypress.com/issue_articles/uk-guidance-on-registering-medical-devices-to-place-on-the-market-has-been-updated/ 2026-04-30T09:52:07+00:00 https://globalregulatorypress.com/issue_articles/una-mirada-actualizada-a-los-requisitos-reguladores-para-dispositivos-medicos-incluyendo-los-dispositivos-medicos-para-diagnostico-in-vitro-en-cuba/ 2026-04-30T09:52:08+00:00 https://globalregulatorypress.com/issue_articles/usa-class-ii-classification-for-alzheimers-disease-pathology-assessment-tests/ 2026-04-30T09:52:08+00:00 https://globalregulatorypress.com/issue_articles/usa-digital-therapy-devices-for-amblyopia-have-been-classified-into-class-ii/ 2026-04-30T09:52:09+00:00 https://globalregulatorypress.com/issue_articles/usa-device-for-sleep-apnoea-testing-based-on-mandibular-movement-is-class-ii/ 2026-04-30T09:52:09+00:00 https://globalregulatorypress.com/issue_articles/usa-class-ii-classification-for-the-manual-surgical-instrument-for-appropriate-patient-selection-for-orthopaedic-implant/ 2026-04-30T09:52:09+00:00 https://globalregulatorypress.com/issue_articles/usa-devices-proposed-for-exemption-from-pre-market-notification/ 2026-04-30T09:52:09+00:00 https://globalregulatorypress.com/issue_articles/usa-guidance-on-incorporating-voluntary-ppi-over-the-total-product-lifecycle/ 2026-04-30T09:52:09+00:00 https://globalregulatorypress.com/issue_articles/usa-guidance-published-on-medical-devices-with-indications-associated-with-weight-loss/ 2026-04-30T09:52:09+00:00 https://globalregulatorypress.com/issue_articles/usa-non-invasive-bone-growth-stimulators-become-class-ii-subject-to-special-controls/ 2026-04-30T09:52:10+00:00 https://globalregulatorypress.com/issue_articles/usa-reclassification-of-optical-diagnostic-devices-for-melanoma-detection-and-electrical-impedance-spectrometers-into-class-ii/ 2026-04-30T09:52:10+00:00 https://globalregulatorypress.com/issue_articles/usa-proposed-classification-of-blood-irradiator-devices/ 2026-04-30T09:52:10+00:00 https://globalregulatorypress.com/issue_articles/usa-proposed-reclassification-of-qualitative-mycobacterium-tuberculosis-cell-mediated-immune-response-assays/ 2026-04-30T09:52:10+00:00 https://globalregulatorypress.com/issue_articles/usa-new-approach-speeds-access-to-medicare-coverage-of-breakthrough-devices/ 2026-04-30T09:52:10+00:00 https://globalregulatorypress.com/issue_articles/usa-medical-device-inspections-to-be-conducted-under-an-updated-process/ 2026-04-30T09:52:10+00:00 https://globalregulatorypress.com/issue_articles/usa-modifications-to-the-list-of-fda-recognised-standards-3/ 2026-04-30T09:52:10+00:00 https://globalregulatorypress.com/issue_articles/usa-setmelanotide-eligibility-gene-variant-detection-systems-become-class-ii/ 2026-04-30T09:52:11+00:00 https://globalregulatorypress.com/issue_articles/usa-transcutaneous-electrical-nerve-stimulator-for-the-relief-of-congestion-classified-into-class-ii/ 2026-04-30T09:52:11+00:00 https://globalregulatorypress.com/issue_articles/usa-updated-guidance-on-cybersecurity-in-medical-devices/ 2026-04-30T09:52:11+00:00 https://globalregulatorypress.com/issue_articles/usa-revocation-of-regulations-concerning-mutual-recognition-of-certain-medical-device-quality-system-audit-reports-and-product-evaluation-reports/ 2026-04-30T09:53:16+00:00 https://globalregulatorypress.com/issue_articles/use-of-artificial-intelligence-in-literature-screening-for-regulatory-compliance/ 2026-04-30T09:53:17+00:00 https://globalregulatorypress.com/issue_articles/usa-withdrawal-of-2015-proposed-rule-on-sunlamp-products/ 2026-04-30T09:53:17+00:00 https://globalregulatorypress.com/issue_articles/usa-usp-665-focuses-on-plastic-components-in-production/ 2026-04-30T09:53:17+00:00 https://globalregulatorypress.com/issue_articles/vietnam-advertising-of-medical-devices/ 2026-04-30T09:53:18+00:00