• 2026-07-27 03:35:56

The Medical Device Authority (MDA) of Malaysia has published a revised guidance document, MDA/GD/0026: Requirements for Labelling of Medical Devices. This revision updates the requirements for inclusion of foreign manufacturer contact details on medical device labels. The revised requirements took effect on 22 May 2026.

• 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.

• 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.

• 2025-07-10 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.

• 2025-01-22 09:19:30

In 2024, Qualtech Consulting Corporation achieved significant milestones, including expanding our services to support Korean MFDS registrations, celebrating the 10th anniversary of our Malaysian office, and hosting impactful webinars addressing regulatory and market opportunities in Europe, ASEAN, Brazil, and India. As we prepare for 2025, we are focused on expanding knowledge-sharing efforts, entering emerging markets such as Latin America and the Middle East, and celebrating 25 years of supporting medical device manufacturers globally.

• 2024-06-20 06:09:46

This announcement outlines measures to reinforce the supervision and management of commissioned production by medical device registrants, ensuring the full implementation of quality and safety responsibilities and effective risk prevention and control in accordance with regulations.

• 2023-11-20 01:57:54

This Q&A document answers questions on transitional provisions for products without an intended medical purpose covered by Annex XVI of the MDR.

• 2023-06-28 07:48:07

This guidance aims to provide a clear understanding of what changes to design or intended purpose would be considered 'significant'. It also provides several flowcharts in order to facilitate a harmonized judgement of the significance of a change.

• 2023-04-25 01:59:50

Regulation (EU) 2023/607 of the European Parliament and of the Council of 15 March 2023 amends the MDR and the IVDR as regards to the transitional provisions for certain medical devices and in vitro diagnostic medical devices.

• 2023-02-23 02:05:29

In order to supervise medical device registrants taking the responsibilities for medical device quality and safety, NMPA has issued the so-called "Regulations on Enterprises Implementing the Supervision and Management of Responsibilities for Medical Device Quality and Safety".