• 2025-04-24 06:13:27

Australia’s implementation of the Unique Device Identification (UDI) system marks a major advancement in medical device traceability and regulatory oversight. This article provides medical device manufacturers with essential guidance on the TGA’s UDI requirements, timelines, and compliance obligations from 2025 through 2030. It also outlines key roles, exemptions, and actionable strategies to support successful market access and patient safety.

• 2024-12-16 10:35:14

Qualtech simplifies medical device registration and post-market compliance in China by addressing NMPA requirements with personalized guidance and localized expertise. From ensuring submission-ready dossiers to managing regulatory feedback and proactive surveillance, their support streamlines compliance, safeguards product reliability, and enhances market success.

• 2022-08-30 02:54:29

The Center for Medical Device Evaluation (CMDE) has formulated “Technical Guidelines for the Compliance of the <Basic Principles of Medical Device Safety and Performance>".

• 2020-12-24 10:54:11

Thai FDA has recently announced a list of standards to be complied by disposable surgical masks, upon making a set of COVID-19 related medical devices announcement.