• 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.

• 2025-09-24 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.

• 2025-08-15 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.

• 2023-10-20 06:51:30

The Medical Device Authority (MDA) announced on 19th September that any event involving registered medical devices that occurs outside of the country is not required to be reported to MDA if the incident has been notified to the regulatory agency in the country where the incident happened and corrective action or precautions have been taken by the manufacturer or establishment.

• 2023-09-27 06:54:16

The Medical Device Authority (MDA) released implementation requirements for QMS and traceability forms on August 4th. Starting January 1, 2024, only the recognized QMS standards will be accepted for new and re-registration of medical devices.

• 2022-12-27 05:37:15

The Malaysia Medical Device Authority (MDA) published the updated Sixth Edition Guidance Document, “Requirement for Labelling of Medical Device” (MDA/GD/0026), on November 21, 2022. MDA has made a few changes, respectively. MDA/GD/0026 is intended to assist manufacturers and authorized representatives with guidance on the content of medical device labelling. Labelling is used to both identify particular medical devices and to convey safety and performance-related information to patients or users of medical devices.

• 2022-03-25 11:49:26

The Medical Device Authority (MDA) produced this new Guidance Document to assist the medical device industry and healthcare practitioners in complying with the Medical Device Act (Act 737) and its regulations.

• 2021-02-22 01:43:21

Masks and respirators, in various denominations. have become essential things in the new norm of life. There are many types of masks and respirators available in the Malaysian market. Thus, Malaysia Device Authority (MDA) published a new guidance document as a reference for stakeholders. This guidance explains of the type of face masks and respirators that are regulated under the Medical Device Regulations 2012 and the pre-requisites they need to fulfil.