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Global Regulatory Tracking

With timeliness, accuracy and practicality at its core, WISELINK offers regulatory updates, interpretations and trend analysis to help businesses navigate global compliance and drive global growth.

Medical Device Labeling in Canada: Interpretation of 10 Mandatory Label Items & Bilingual Requirements

2026-10-14

Understanding MDCG 2020‑16 rev.2 | Core Guidance on IVD Product Classification under EU IVDR

2026-10-13

Must-Know Guide: UKCA Marking for Medical Devices in 2026 – Key FAQs & Essentials

2026-10-12

FDA Update! 14 Classes of Class II Toxicology Testing Systems Qualify for 510(k) Exemption!

2026-10-10

EU CE: Multiple Core Standards Updated in 2026, Immediate Self-Review Required for MDR Technical Documentation

2026-10-09

Australia’s TGA Releases Full‑Scale UDI Guidance for Healthcare！

2026-10-08

A Complete Guide to Canada Medical Device Application Types (Part 1): Detailed Rules for Determining Single/Family/Group/System

2026-09-23

EU UDI Three Codes Breakdown: What Are the Differences Between Basic UDI-DI, UDI-DI and UDI-PI?

2026-09-22

Roszdravnadzor Updates Administrative Regulations for Medical Device Registration! Full Adjustments to Applicant Qualifications, Certificate Format and Review Timelines

2026-09-21

Full English Translation: Complete Guide to Sri Lanka NMRA Medical Device Registration

2026-09-20

Egyptian IVD Registration: Two Review Pathways — Pick the Right One to Save Half a Year!

2026-09-18

Registration of Radiation-Based Medical Devices in Indonesia: The Dual Regulatory Pathway of BAPETEN and MOH Cannot Be Ignored!

2026-09-17

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