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

    Suspension and Cancellation of Establishment Licence and Medical Device Registration. Semua establismen yang menjalankan aktiviti meletakkan peranti perubatan dalam pasaran perlu mempunyai Lesen Establismen dan peranti perubatan tersebut perlu didaftarkan seperti yang termaktub dalam Akta Peranti Perubatan 2012 (Akta 737).

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

    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.

  3. mda.gov.my › index › documentsHOW TO APPLY FOR MEDICAL DEVICE REGISTRATION UNDER MEDICAL DEVICE...

    Please select the class of medical device based on the classification rules of medical device as specified in Second Schedule of Medical Device Regulation 2012 and further elaborated in the Guidance Document on The rules of Classification for general medical devices (MDA/GD-04).

  4. 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.

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

    2 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.

  6. portal.mda.gov.my › index › documentsGUIDELINE FOR RE-REGISTRATION OF REGISTERED MEDICAL DEVICE

    The validity of a medical device registration is 5 years. Upon the expiry of the registration, the registration holder shall apply for re-registration of the medical device before it

  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.

  8. portal-cloud.mda.gov.my › index › msPortal Rasmi Pihak Berkuasa Peranti Perubatan Malaysia

    2 Jul 2024 · Awam Aduan (FEMES) Aduan Keselamatan & Prestasi Peranti Perubatan Maklumat dan Kesedaran Maklumat keselamatan Advertisement Approval Industri Pendaftaran Peranti Perubatan Medical Device Registration Information Tukar Pemberitahuan Produk Gabungan Pendaftaran Semak Status Peranti Perubatan MeDCASt V1.0 MeDCASt V2.0 Conditional Approval Lesen Establismen Establishment License Information Badan ...

  9. andamanmed.com › regulatory-services › medical-device-registrationMedical device registration in Malaysia - Andaman Medical

    Medical device registration in Malaysia is regulated by the Medical Device Authority (MDA), a federal statutory agency under the Ministry of Health (MoH). The MDA implements and enforces the Medical Device Act 2012 (Act 737).

  10. www.pacificbridgemedical.com › medical-device › product-registrationMedical Device Registration In Malaysia | Regulatory Services

    Learn about the Malaysia medical device registration pathway, regulations, and gaining approval from the Malaysia Medical Device Authority (MDA).