• 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.

• 2026-01-30 04:29:37

The European Union has established post-market surveillance (PMS) requirements under the Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR) to ensure the continuous safety and performance of medical devices and IVDs placed on the market. This framework emphasizes proactive monitoring, data collection, and lifecycle-based compliance to promptly identify and address potential risks.

• 2026-01-30 04:16:17

NMPA released the 2025 Catalog of High-End Medical Devices for Priority Approval to expedite the registration process for innovative high-end medical devices.

• 2026-01-30 03:45:43

The NMPA issued revised regulation on the administration of export sales certificates of medical devices, effective May 1, 2026.

• 2025-12-26 04:07:51

Qualtech 2025 Southeast Asia Medical Device Compliance Update Webinar Part 2 provides an overview of key regulatory updates in Singapore, Malaysia & the Philippines. The session highlights changes in ASEAN medical device regulations, including system upgrades, regulatory reliance initiatives, evolving submission and classification requirements by Singapore HSA, Malaysia MDA & Philippines FDA, offering insights for medical device compliance planning in 2026.

• 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(GMP), the regulation will officially enter into force on November 1, 2026, at which time the 2014 version shall be repealed.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 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.

• 2025-11-10 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.

• 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.