• 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 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.

• 2025-11-21 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.

• 2025-10-27 03:24:28

The Malaysia Medical Device Authority (MDA) has published the latest Conformity Assessment Body (CAB) guide and establishment guide to medical device registration submission in MeDC@St for Conducting Assessment by Way of Verification process, which includes updates on additional recognized regulatory authorities and revised verification procedures to help establishments streamline registration and ensure regulatory compliance.

• 2025-10-27 02:53:36

The Malaysian Medical Device Authority (MDA) has been recognized as an Affiliate Member of the Medical Device Single Audit Program (MDSAP). MDA will now accept MDSAP audit reports and certificates as evidence of QMS compliance, streamlining device registration and reducing audit duplication for manufacturers.

• 2025-09-24 09:35:21

On September 4, 2025, Qualtech hosted a webinar focusing on the medical device regulatory landscapes of Japan and South Korea. Led by our Japan and South Korea Registration Team Leaders, the session offered participants a structured overview of both markets, covering regulatory frameworks, registration pathways, and key updates shaping compliance today.

• 2025-09-24 07:40:52

PMDA has revised the approach to biological safety evaluation and abolished the previous notification issued on Jan 6, 2020. The revised approach focuses on providing practical instructions for preparing regulatory submissions.

• 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 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.

• 2025-07-10 10:02:10

The Malaysia Medical Device Authority (MDA) has published the latest edition of Harmonised Borderline Products in ASEAN which provides an updated classifications list for products that may fall under medical device regulations across ASEAN member states. This update helps establishments to determine their products classification (medical device or non-medical device).