South Korea’s medical device market is rapidly expanding, driven by technological innovations and increasing healthcare demands. As the market grows, understanding Korean medical device regulations is ...

The Food and Drug Administration (FDA) development and approval process for drugs and medical devices involves multiple phases that ensure the safety and effectiveness of products before and after ...

An accelerated regulatory pathway in Mexico has positioned the country as a priority launch market for medical devices. Guerreschi: This pathway is designed to reduce approval timelines by the Federal ...

On February 2, 2026, the U.S. Food and Drug Administration’s long-awaited harmonization of the medical device good manufacturing practice ...

At the upcoming MD&M East show in New York City in May, Janet Kwiatkowski, MBA, MSRA, president and CEO of MAE Group, will give a talk entitled “Importance of Early Dialog & Interaction with the FDA.” ...

On 20 January 2026, Ropes & Gray’s Global Life Sciences Regulatory & Compliance team hosted the “Life Sciences Regulatory Outlook 2026” webinar.

For Orthocell Ltd (ASX:OCC, OTC:ORHHF), the focus in 2026 is no longer on regulatory milestones. With US FDA approval secured ...

The advent of artificial intelligence (AI) and data-driven methodologies has triggered a wave of transformation in regulatory compliance and quality assurance for the development of medical devices.

PMA, and DeNovo submissions to bring medical devices to the US market. Recent 510(k) modifications for new technologies and safety advancements, along with AI integration, present significant ...

This article will examine market access outside the EU/EEA based on reliance and recognition. For countries outside the European Union (EU) and European Economic Area (EEA), regulatory reliance and ...

January 13, 2026 - PRESSADVANTAGE - In the highly regulated field of medical device labeling translation, ensuring that ...