• 2025-08-25 05:57:23

Thai FDA has announced a significant update to the renewal process for Class 2, 3, 4 medical device certificates, effective from 22 July 2025. This reform introduces streamlined procedures, with automatic renewals for full CSDT dossiers and differentiated requirements for Partial pathway registrations. By reducing unnecessary document submissions, the Thai FDA aims to balance regulatory efficiency with patient safety.

• 2025-08-25 05:37:56

Thai FDA has recently introduced an optimized process for certain medical device advertisements, allowing specific categories of promotional content to be automatically approved. The framework accelerates market communication while maintaining compliance.

• 2025-08-25 04:38:43

The Minister of Finance promulgated Circular 64 /2025/TT-BTC dated June 30, 2025, which lowered fees to alleviate difficulties and support production and business activities.

• 2025-08-25 03:35:27

The Ministry of Health Malaysia (MOH) has announced an international regulatory collaboration with China National Medical Products Administration (NMPA). This collaboration aims for accelerate pre-market approvals, quicker market access, reduced costs and enhanced patient care while strengthens Malaysia's role as regional regulatory hub.

• 2025-08-25 03:07:39

Indonesia's Ministry of Health has issued Decision Letter No. HK.01.07/MENKES/736/2025, which outlines the types of medical devices that may be sold by retail business operators. This regulation clarifies the criteria that these devices must meet and the obligations that retailers must follow when engaging in the sale of medical device. It also provides a reference list of medical devices that are eligible for retail distribution under this policy.

• 2025-07-07 08:26:29

Join Qualtech's upcoming webinar, "Accelerating Innovation: Why Australia is the Ideal Partner for Your Next Clinical Trial" to explore how Australia's clinical trial environment supports faster, cost-effective, and globally recognized medical device development. The session will feature insights from Mobius Medical Pty Ltd, Qualtech's CRO trusted partner in Australia, and highlight key advantages including expedited approvals, R&D tax incentives, and data acceptance by major regulators such as the U.S. FDA.

• 2025-04-24 09:48:40

On March 26, 2025, Qualtech hosted a regulatory webinar exploring the process of medical device approval in Australia. The session covered essential topics including device classification, conformity assessment options, ARTG registration steps, sponsor and manufacturer obligations, post-market surveillance, and upcoming UDI requirements. Practical tips and FAQs helped attendees better prepare for TGA submissions and long-term compliance in the Australian market.

• 2025-04-24 10:18:36

The Total Artificial Heart (TAH) project, supported by a hefty AUD50 million investment from the Australian Government, is poised to redefine the future of cardiac care. As it progresses into the stage of human trials, the TAH could potentially serve as a viable long-term solution to heart transplants, thereby establishing Australia as a global leader in the fight against cardiovascular diseases.

• 2025-04-24 03:49:40

The Therapeutic Goods Administration (TGA) has introduced updated regulatory requirements, effective from July 1, 2024, for medical devices containing medicinal, microbial, recombinant, or animal-origin substances. These changes aim to streamline classification rules, update labelling requirements, and broaden the recognition of international regulatory approvals, thereby reducing unnecessary regulatory burdens while maintaining safety standards.

• 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.