• 2026-06-26 04:47:11

Australia's Unique Device Identification (UDI) system is moving from concept to reality, with the first mandatory compliance deadlines commencing in July 2026. Designed to strengthen patient safety, device traceability, and post-market surveillance, the phased implementation will introduce new obligations for both manufacturers and sponsors. This article explores how UDI works, key TGA compliance milestones, and what medical device companies should do to prepare.

• 2025-08-25 07:35:29

The NMPA has released new measures to foster innovation and strengthen regulation of high-end medical devices such as surgical robots, advanced imaging systems, AI medical devices, and innovative biomaterials. The policy emphasizes faster review pathways, improved standards, stronger lifecycle oversight, and enhanced international collaboration, aiming to accelerate market access and boost the global competitiveness of China's medical device industry.

• 2025-03-10 02:22:15

Join Qualtech's webinar on March 26, 2025, for key insights into Australia's medical device market and TGA regulations. Learn about the registration process, Sponsor responsibilities, post-market requirements, and get answers to common questions. Register now here to secure your spot!

• 2024-09-17 03:17:46

Indonesia's Ministry of Health has issued Regulation No. 3 Year 2024 as a new derivative to the previous halal regulations on medical devices, providing a more specific outline on the mandate for medical device halal certification. This regulation introduces stringent requirements for manufacturing, labeling, and material disclosure.

• 2024-06-27 05:11:25

This article provides a comprehensive guide on TGA sponsors, a critical partner for medical device companies seeking to enter the Australian market. It explains the role of the Therapeutic Goods Administration (TGA) and how a TGA sponsor acts as a liaison, navigating the complex regulatory process to ensure compliance.

• 2024-03-01 06:21:15

The FDA has released a final rule amending regulation amending the current good manufacturing practice (CGMP) guidelines for medical devices under the Quality System (QS) Regulation. This rule entails an amendment to 21 CFR 820, adopting the quality management system standards outlined in the ISO 13485:2016, established by the International Organization for Standardization (ISO).

• 2024-01-26 07:08:51

A regulation on the management of emergency use of medical devices (trial) is issued.

• 2023-08-23 06:27:14

Qualtech highlights the critical role of cybersecurity in safeguarding medical devices and patient well-being, emphasizing the potential risks posed by connectivity and the need for stringent measures to counteract vulnerabilities. We emphasize the collaborative efforts required among medical device stakeholders to establish and maintain robust security standards. This QT analysis revisits a previous cybersecurity article with a focus on recent developments in Japan, China, and Singapore.

• 2023-08-23 06:09:04

Due to Regulation (EU) 2023/607, the transition period is extended. Some timelines of the related factsheet or guidance are modified accordingly.

• 2022-08-30 03:43:54

PFDA issues the updated regulation for Medical Radiation Devices that aims to provide guidelines for the importation of radiation devices used for both medical and non-medical applications in accordance to AO 2018-0002.