Giulia Guerreschi

Since September 2025, COFEPRIS's new Abbreviated Pathway has opened a faster, more accessible route to market for manufacturers who already hold approvals from major regulatory bodies like the FDA, CE, Health Canada, and others. Instead of navigating a lengthy full technical review, you can now leverage your existing approvals to dramatically cut submission time and complexity. This guide breaks down everything you need to know — from eligibility requirements and device classification to documentation, timelines, and how to appoint a Mexico Registration Holder.

Your medical device and IVD approvals in the US and EU can streamline pathways in 25+ markets worldwide, from Australia and Switzerland to Brazil and Singapore, cutting the time and cost of international expansion. And with AI-powered tools now helping regulatory specialists build submissions up to 50% faster, scaling your device portfolio across borders has never been more achievable.

Australia is a highly attractive market for medical device manufacturers, but gaining access requires navigating the TGA's rigorous registration process. This step-by-step guide covers the full pathway to ARTG inclusion, from device classification and Sponsor obligations through to Manufacturer Evidence, application submission, and audit preparation, with practical guidance on costs and timelines.

Mexico’s COFEPRIS will launch its new Abbreviated Regulatory Pathway on September 1, 2025, enabling medical device and drug manufacturers to fast-track approvals by leveraging prior authorizations from trusted international regulators. The streamlined process promises 30-day evaluations, aligning Mexico more closely with global regulatory standards and offering manufacturers a faster route to market.

The European Commission has confirmed that key EUDAMED modules will become mandatory by Q3 2026 and manufacturers selling into the EU need to be ready. This article outlines five key reasons to prioritize EUDAMED registration now to avoid disruption, ensure compliance, and maintain market access.