• 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.

• 2025-08-15 01:48:59

On September 4th, join Qualtech for an insightful webinar, "Entering Japan and South Korea: Understanding PMDA and MFDS Requirements for Medical Devices". This session will offer practical guidance on navigating the regulatory systems of Japan and South Korea – ideal for companies seeking to accelerate market entry and avoid compliance-related issues.

• 2025-07-10 08:37:53

During Medical Taiwan 2025, Qualtech engaged with manufacturers and distributors seeking trusted support for regulatory navigation and market expansion across the APAC region. With growing opportunities throughout this dynamic market, Qualtech continues to serve as a trusted partner for global medical device manufacturers expanding across Asia.

• 2025-07-10 09:00:31

Vietnam is experiencing a significant rise in cardiovascular disease (CVD). This article highlights the alarming rate at which heart diseases are affecting the population and its substantial impact on the Vietnamese health. The growing burden of CVD is also creating a significant market for cardiac medical instruments to prevent, detect and treat CVD in Vietnam.

• 2025-07-14 01:44:36

The NMPA issued the Catalog of Medical Devices Exempt from Clinical Evaluation (2025), which took effect on May 12, 2025.

• 2025-07-10 09:45:06

The Japanese Ministry of Health, Labour and Welfare is enforcing the implementation of the new JIS standard for Electromagnetic Compatibility (EMI/EMC) (JIS T 0601-1-2:2023) as of February 25, 2026.