Canada
16 articles
Teleflex Global Regulatory Dossier: Arrow, UroLift, FDA Data & 2025 Sale
Data-driven regulatory dossier of Teleflex (NYSE: TFX): ~440 FDA 510(k)s, multi-country registration counts, Arrow Class I recalls, and the 2025 $2.03B divestiture.
MDSAP in 2026: Revised Audit Approach, TGA Migration, and Post-QMSR Value
A strategic evaluation of MDSAP in 2026: analyzing the February 2026 revised audit approach, the TGA mdsap.global migration, and a post-QMSR ROI decision framework.
Adaptive AI Medical Devices: Why an FDA PCCP Won't Update Your Model in the EU or Japan
A cross-market analysis of AI medical device change control, comparing the US FDA PCCP, Japan's IDATEN framework, and the EU's MDR and AI Act modification rules.
Why One FDA/CE Clearance Opens Far Fewer CGM Markets: The Global Class-Divergence Map
A comprehensive cross-market analysis of continuous glucose monitor (CGM) classification, clinical trial requirements, and reimbursement gates across the US, EU, China, Japan, and Canada.
Philips Worldwide Regulatory and Safety Footprint: 26-Market Registry Teardown
A comprehensive database analysis detailing Philips' 7,909 distinct registrations across 26 global markets, integrated with clinical trial data and patent portfolios.
Siemens Healthineers Global Regulatory Footprint: 28-Market Registry Breakdown
A comprehensive database analysis detailing Siemens Healthineers' 18,956 distinct registrations across 28 global markets, including IVD, imaging, and oncology segments.
Philips FDA Device Footprint: Clearances, Recalls & Consent Decree
A comprehensive regulatory dossier analyzing Philips' FDA clearances, cardiovascular PMA distribution, recall history under the 2024 consent decree, and global manufacturing plants.
Investigational Device Rules Compared: FDA 21 CFR 812, EU MDR, SFDA & Health Canada
Side-by-side comparison of investigational device rules: FDA 21 CFR Part 812 IDE, EU MDR Articles 62-82, Saudi SFDA MDS-REQ 2, and Canada's Investigational Testing Authorization.
Medical Device Economic Operator Duties Compared: EU MDR, NZ, Singapore, Canada, SFDA
Compare sponsor, importer, distributor and authorized-representative duties across EU MDR Articles 11-16, New Zealand WAND, Singapore HPA, Canada MDEL and Saudi SFDA MDS-REQ 9.
Canada MDALL Class III/IV Analysis: US Companies Hold 48% of High-Risk Listings
US companies hold 48% of Canada's 57,000 Class III/IV MDALL listings. Median device age is 9.7 years and 49% of devices are over a decade old. Full data analysis.
Health Canada REP and CESG Digital Submissions for Medical Devices
Prepare for mandatory REP and CESG submissions for Class II-IV medical device licences, including IMDRF ToC format, XML templates, workflow changes, and April 2026 scope.
Health Canada MLMD Guidance 2026: PCCP, Bias, and AI Lifecycle
Guide to Health Canada's 2026 MLMD guidance for AI/ML devices, including PCCPs, data quality, bias controls, lifecycle risk, digital submissions, and FDA/EU comparisons.
Health Canada Medical Device Regulation Reform 2026
Understand Health Canada's 2026 device reforms, including Terms and Conditions powers, AI/ML guidance, REP, IMDRF ToC, significant changes, and market access actions.
MDSAP Audit Preparation: Complete Guide for Medical Device Manufacturers (2026)
Everything you need to prepare for an MDSAP audit — the 2026 updated audit approach (AU P0002.010), QMSR alignment, step-by-step preparation checklist, costs, timelines, and common nonconformities.
Health Canada Medical Device License: The Complete Guide
How to obtain a Medical Device License from Health Canada — classification, MDSAP requirements, MDEL, application process, fees, and practical guidance for the Canadian market.
MDSAP Audit: The Complete Guide to the Medical Device Single Audit Program
Everything about MDSAP — the single audit program covering FDA, Health Canada, TGA, ANVISA, and MHLW. Audit process, grading, preparation, costs, and how to pass.