• 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.

• 2025-12-26 03:31:27

The Malaysian Medical Device Authority (MDA) has implemented a Product Classification Letter with a two-years (2) validity in alignment with regulatory requirements. Letters issued before specified dates may expire or require renewal under the updated framework.

• 2025-12-26 03:21:16

On November 4, 2025, the NMPA released the revised Good Manufacturing Practice for Medical Devices (GMP), the regulation will officially enter into force on November 1, 2026, at which time the 2014 version shall be repealed.

• 2025-12-26 02:17:11

The Hong Kong Department of Health (DH) is enhancing its medical device procurement strategy under MDACS. Following the implementation of Stage B on 1st November 2024, DH will introduce Stage C which will take effect on 23 March 2026. Under this enhanced measure, all applicable medical devices classified as Class II-IV or B-D procured by DH must be listed under MDACS. This policy aims to strengthen public health protection by ensuring the safety, quality and performance of medical devices used in public healthcare facilities, while also promoting wider adoption of MDACS in preparation for future statutory regulation.

• 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.

• 2025-11-26 06:54:12

On 2 October 2025, the Singapore Health Sciences Authority (HSA) conducted the Health Products Regulatory Conference 2025, which was held jointly with the Singapore Manufacturing Federation (SMF) MedTech Day. The event elevated the theme: "Advancing Singapore's Medtech Ecosystem: be connected, collaborative, and future-ready".
During the conference, the HSA's Medical Device Cluster (MDC) shared insights on the evolving regulatory landscape, examining both present developments and anticipated future trends in the field, especially related to digital health products.

• 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.

• 2025-11-21 07:03:32

PMDA updated the document requirements for QMS conformity inspections on October 1, 2025. The following is a summary of the revisions to the submission requirements for the QMS Conformity Inspection documents, comparing the version dated January 18, 2024 with the version dated October 1, 2025.

• 2025-11-10 07:33:05

Join Qualtech's upcoming webinar, "Southeast Asia Medical Device Compliance Update Series 2025 Part 2: Singapore, Malaysia & the Philippines", to gain valuable insights into three of ASEAN's most active and evolving medical device markets. This session will feature Qualtech's local regulatory experts, who will share the latest updates, policy trends, and compliance strategies across Singapore, Malaysia & the Philippines. Updates include current regulatory developments, harmonization efforts, and practical approaches to maintaining compliance while expanding in Southeast Asia.