• 2026-04-02 01:20:01

Health Sciences Authority (HSA) has responded to feedback from its public consultation on a proposed regulatory sandbox that exempts selected low‑risk artificial intelligence software as a medical device (AI‑SaMD) from manufacturer licensing and product registration requirements under controlled conditions. The sandbox aims to balance regulatory oversight and innovation by allowing public healthcare institutions to develop and deploy AI tools for non‑critical medical conditions while collecting real‑world insights to inform future regulatory frameworks.

• 2026-03-20 06:20:35

Meet us at CMEF 2026 in Shanghai to explore full lifecycle compliance services, integrated clinical trial capabilities, and streamlined global registration solutions. With local regulatory connections and multidisciplinary expert support, we offer on-site consultation and personalized guidance.

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• 2026-02-26 07:44:34

The Thai Food and Drug Administration (Thai FDA) and the Medical Device Authority (MDA) of Malaysia have initiated the Pilot Reliance Project, a joint effort to facilitate medical device registration by recognizing each othe's regulatory approvals. The pilot project is effective from February 2026 until 30 April 2026.

• 2026-02-25 04:43:48

Thai FDA has provided recommendations on applicable international standards for particular types of active medical devices to support medical device registration in Thailand. These standards are presented as advisory references only and are intended to assist the registrants in preparing relevant test reports in accordance with the ASEAN Common Submission Template Dossier (CSDT).

• 2026-01-30 07:13:08

Thailand has updated its medical device labeling and IFU regulation, which will take effect on June 20, 2026. The new regulations expand the scope to include Software as Medical Device (SaMD), reusable surgical and dental instruments, and medical device accessories. Manufacturers and Importers are granted transition period until June 20, 2028, to transition from the 2020 requirements to the new 2025 requirements. Medical device companies marketing products in Thailand must update their labeling and IFU to comply with this updated announcement by the enforcement deadline.

• 2025-12-26 03:50:42

The Thai FDA has issued new Clinical Evaluation Report (CER) guidance that fully adopts the IMDRF framework without modification. As a result, IMDRF-compliant CERs can be used for Thai submissions with minimal administrative adjustment, supporting regulatory harmonization and reduced duplication.

• 2025-11-26 08:01:00

Artificial Intelligence (AI) is rapidly transforming healthcare in Australia, offering innovative solutions to meet the growing demands of an aging population and chronic disease management. With the AI healthcare market projected to reach AUD 1.78 billion by 2030, AI's potential to enhance early diagnosis and optimize treatments is substantial. Despite challenges like data fragmentation and regulatory complexities, AI is set to revolutionize healthcare delivery across the country.

• 2025-11-26 07:23:46

This article summarizes key insights from Qualtech's 2025 ASEAN regulatory webinar, highlighting major updates in Indonesia, Thailand and Vietnam. The recap covers changes in retail rules, procurement, halal enforcement, reliance pathways and registration procedures, reflecting how these markets are streamlining medical device approvals and improving regional market access.

• 2025-10-27 04:49:01

To simplify preparation and expedite event organization, the Thai FDA announced that no advertising license is required for presenting medical devices at national, or international academic exhibitions and conferences. Academic events that meet the specified conditions may qualify for this exemption.

• 2025-10-27 04:30:17

List of selected frequently asked questions regarding the renewal of the medical device approval certificates. Originally in Thai, this English version offers practical guidance for maintaining compliance with Thai FDA requirements.