Regulatory Update: MDA Announcement About MEDCREST

On July 14, 2022, the Medical Device Authority (MDA) announced that the Medical Device Centralized Reporting System (MEDCREST) is now available for use by medical device companies.

MEDCREST is a user-friendly online application that allows companies to inform the MDA about their post-marketing activities. This includes mandatory problem reporting, field corrective actions, and recall actions.

Starting July 15, 2022, all post-market activities—such as mandatory problem reporting, field corrective actions, and recall actions—can be conducted by accessing the website https://medcrest.mda.gov.my/login.

The website also provides various resources, including manual documents, user manuals, and a helpdesk, to assist users in the reporting process.

For more information, you can read the original announcement at the MDA's official website.

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Source :
Pengumuman MEDCREST – Medical Device Authority (MDA)