• 2026-06-26 06:37:19

Effective May 15, 2026, Decree No. 90/2026/ND-CP replaces Decree No. 117/2020/ND-CP, strengthening administrative sanctions and compliance control in Vietnam’s medical device sector. Non-compliance may result in higher fines, product circulation restrictions and temporary business suspension, which may affect supply chains and hospital tenders. To maintain smooth operations, companies are recommended to review classifications, verify localized labeling and align workflows with applicable regulatory timelines.

• 2026-06-26 05:40:00

South Korea has introduced amendments to both the Medical Device Act and the Regulation on Medical Device Approval, Notification, and Review, bringing important updates for manufacturers and importers. Key changes include expanded use of real-world evidence (RWE), simplified documentation requirements, a broader transition period for approved changes, and the establishment of a formal quality management system (QMS) conformity recognition framework. The amendments reflect South Korea's ongoing efforts to enhance regulatory efficiency, strengthen oversight, and support innovation in the medical device sector.

• 2026-04-23 09:23:51

The Department of Infrastructure and Medical Devices will transition the domain of its online public service portal to https://vimda.moh.gov.vn effective April 1, 2026. The current domain will remain active until September 30, 2026, to ensure a smooth transition. Users are encouraged to switch to the new domain promptly.

• 2026-04-02 02:37:23

Decree No. 37/2026/ND-CP introduces updated labeling requirements in Vietnam, replacing previous regulations. It strengthens and supplements the rules on mandatory label information, while also introducing additional provisions on electronic labeling and specific requirements for medical devices. Transitional provisions are included to support the continued use of previously compliant labels for a limited period.

• 2026-04-01 09:14:49

The proposed PFDA guidelines establish requirements for maintaining importation and distribution records and for reporting product complaints, adverse events, and field safety corrective actions for medical devices to ensure traceability and facilitate appropriate regulatory action. This article outlines the specific responsibilities, strict reporting timelines, and record-keeping mandates designed to protect public health throughout the device lifecycle.

• 2026-02-25 04:14:57

The Ministry of Food and Drug Safety (MFDS) has amended the Regulation on Permission, Notification, Review, Etc. of Medical Devices, effective 26 January 2026. The revision expands acceptable clinical documentation, integrates Class II certification responsibilities, refines the regulatory framework for innovative medical devices, clarifies technical documentation requirements, and strengthens cybersecurity submission obligations for connected devices. These updates aim to enhance regulatory clarity, align with international standards, and improve the efficiency of approval and certification procedures in South Korea.

• 2026-01-30 06:02:05

Vietnam faces a surge in respiratory diseases, primarily COPD and asthma. Heavy reliance on imported medical equipment exacerbates the issue. The government's Healthy Lung Program offers hope, but increased demand for respiratory devices creates a market opportunity.

• 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 01:46:53

The 2025 update of the FDA-CDRRHR Citizen's Charter introduces notable changes from its 2024 version, reflecting the agency's continued refinement of service standards, including adjustments in processing timelines.

• 2025-10-14 06:38:43

Join Qualtech's free webinar "Southeast Asia Medical Device Compliance Update Series 2025: Indonesia, Thailand & Vietnam" on October 28, 2025, to gain practical insights into 3 of ASEAN's fastest-growing medical device markets. Learn about key regulatory updates, compliance strategies, and market opportunities directly from Qualtech's local regulatory experts. Stay informed, compliant, and ready for growth in Southeast Asia.