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May 2024 - Establishments are Advised to Submit Medical Device Re-Registration Applications in the [email protected] + System One year Prior to Certificate Expiration Date.
- Overview of Regulatory Medical Device
Medical Device Authority (MDA) is a statutory body under the...
- Medical Device Authority
Suspension and Cancellation of Establishment Licence and...
- Overview of Regulatory Medical Device
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).
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).
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.
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).
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.
Yes, medical devices do require registration before they can be sold in Malaysia. Starting on July 1, 2016, Malaysia’s Medical Device Act has made it mandatory for all foreign manufacturers to register their medical device with the MDA.
