• 2026-06-26 05:40:00

South Korea has introduced amendments to both the Medical Device Act and the Regulation on Medical Device Approval, Notification, and Review, bringing important updates for manufacturers and importers. Key changes include expanded use of real-world evidence (RWE), simplified documentation requirements, a broader transition period for approved changes, and the establishment of a formal quality management system (QMS) conformity recognition framework. The amendments reflect South Korea's ongoing efforts to enhance regulatory efficiency, strengthen oversight, and support innovation in the medical device sector.

• 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.

• 2026-01-30 03:45:43

The NMPA issued revised regulation on the administration of export sales certificates of medical devices, effective May 1, 2026.

• 2025-11-21 08:14:15

The Malaysian Medical Device Authority (MDA) has issued the Medical Device (Amendment) Regulations 2025 [P.U.(A) 330], which were gazetted on 11 September 2025. This amendment revises the fee structure for registrations of Class A medical device effective on or after 1 January 2026. Stakeholders are advised to review the changes and plan their submissions accordingly to ensure timely compliance.

• 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.

• 2025-03-25 05:07:23

China's State Council has issued key amendments to the Regulations on the Supervision and Administration of Medical Devices. The updates broaden emergency use provisions and remove outdated institutional references—reflecting a push for stronger, more responsive regulatory governance in the health sector.

• 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!

• 2025-02-21 05:38:28

Qualtech hosted a webinar providing key insights into the evolving European medical device regulations. The discussion covered essential updates, including the MDR transition period extension, Article 10A supply notification requirements, the gradual rollout of EUDAMED, the implications of the European AI Act, and regulatory changes in the UK and Switzerland. Attendees gained valuable guidance on compliance strategies and proactive measures to navigate these regulatory shifts.

• 2025-02-20 11:17:07

From January 4, 2025, onwards, Thai FDA has tightened medical device advertising rules to prevent misleading claims. Advertisements must align with approved product information, specify target audiences, and include required disclaimers. Stricter enforcement measures target misleads advertising, especially for dermal fillers. Likewise Consumers shall verify approved products on the Thai FDA's website, updated on a weekly bases.

• 2025-01-20 06:54:39

Register our FREE Webinar on 2025 Updates & Forecast for European Medical Device Regulations. Keep your medical device compliance in Europe up-to-date!