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  1. mda.gov.myOfficial Portal of Medical Device Authority (MDA) Malaysia

    4 hari yang lalu · The following documents are summary of some medical device safety information related to potentially hazardous cases. It only serves as a quick reference and in no way should be considered as exhaustive and up-to-date.

  2. mdar.mda.gov.my › frontend › webPublic Search - Malaysia Medical Device Register (MMDR)

    3 hari yang lalu · This facility is provided to enable any interested parties to search for Registered Medical Device, Registered CAB, Licensed Establishments under Section 5, 10, 15 of Medical Device Act 2012 (Act 737) respectively and Notified Medical Device under Medical Device (Exemption) Order 2016.

  3. portal.mda.gov.my › index › industryOverview of Regulatory Medical Device - portal.mda.gov.my

    Medical Device Authority (MDA) is a statutory body under the Ministry of Health Malaysia which was established under the Medical Device Authority Act 2012 (Act 738) to control, regulate medical device, its industry and activities as well as to enforce medical device law under Medical Device Act 2012 (Act 737). 1.

  4. www.mda.gov.my › index › doc-listGuidance Document

    2 Feb 2024 · These Guidance Document was prepared by the Medical Device Authority (MDA) to help the industry and healthcare professionals in their quest to comply with the Medical Device Act (Act 737) and the regulations under it.

  5. mda.gov.my › index › industryMedical Device Registration Information - mda.gov.my

    17 Mei 2024 · Medical Device Registration Information. Introduction: In accordance with Section 5 (1) of the Medical Device Act 2012 (Act 737), no medical device shall be imported, exported or placed in the market unless the medical device is registered under this Act.

  6. portal.mda.gov.my › index › documentsMEDICAL DEVICE GUIDANCE DOCUMENT - portal.mda.gov.my

    This guidance document specifies the categories of changes in relation to registered medical devices and the requirements to be met to continue the importation, exportation or placement of the medical devices in the market. This document applies to all registered medical devices under the Act.

  7. portal.mda.gov.my › index › doc-listGuidance Document

    2 Feb 2024 · These Guidance Document was prepared by the Medical Device Authority (MDA) to help the industry and healthcare professionals in their quest to comply with the Medical Device Act (Act 737) and the regulations under it.