Connect and stay on top of the MedTech regulatory landscape globally.

This week in global device regulatory news, SFDA has introduced major changes to GHTF MDMA license renewal and update requirements and the European Union has updated harmonised standards for medical gloves, device sterilization, and ambulance equipment.

New Australian UDI regulations are now in effect, the impact of the revised EU REP symbol on medical device labeling in the European Union, Mexico's COFEPRIS has announced modifications to GMP requirements, and more in this week's global medical device regulatory updates.

Mexico's COFEPRIS introduced new guidelines for compliance with GMP requirements, the EU reclassified SARS-CoV-2 testing devices, China NMPA issued new guidelines and requirements for medical device inspections, and more in this week's global medical device regulatory update.

This week in medical device regulatory news, the European Commission has updated official guidance on the classification of IVDs under the IVDR; Brazil has opened public consultation on UDI database management and suspended electronic signature requirements; and China revised its regulations on domestic production of imported medical devices.

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Malaysia, a key gateway to Southeast Asia, offers strategic access for businesses. Understanding medical device regulations is crucial for market entry.

In the dynamic world of MedTech compliance, AI plays a pivotal role. It streamlines regulatory research, enhances data analytics for compliance, and automates tasks, ensuring efficiency and accuracy. Looking ahead, AI-driven digital tools promise even greater efficiency, enabling global collaboration and driving the MedTech industry towards innovation and growth.