Malaysia Registration Medical Device

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Official Portal of Medical Device Authority (MDA) …

https://www.mda.gov.my/

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). Orang awam …

General Medical Device - Medical Device …

https://portal.mda.gov.my/industry/medical-device-registration/general-medical-device.html

Section 5(1) of Medical Device Act 2012 (Act 737) requires a medical device to be registered under the Act before it can be imported, exported or placed in …

Public Search - Malaysia Medical Device Register (MMDR)

https://mdar.mda.gov.my/frontend/web/index.php?r=carian

Public Search - Malaysia Medical Device Register (MMDR) This facility is provided to enable any interested parties to search for under Section 5, 10, 15 of Medical …

Medical Device Registration in Malaysia | Emergo by UL

https://www.emergobyul.com/services/medical-device-registration-malaysia

The Malaysian medical device registration process. If your device is approved in one of the recognized reference markets (US, European Union, Australia, Japan or Canada), you can leverage this approval and follow a simplified registration process as outlined below. Download our registration process chart on Malaysia to better understand this process. …

Registration, Licensing & Enforcement - Medical Device …

https://portal.mda.gov.my/faq/registration-licensing-enforcement.html

What is an importer? A distributor is a person or company appointed by an AR (for medical device manufactured in foreign country) or a manufacturer (for locally manufactured …

Malaysia Medical Device Registration and Approval

https://arazygroup.com/medical-device-registration-malaysia/

Medical Device Registration and Approval in Malaysia General country-specific regulatory information is provided on this page for medical device registration …

Re-registration - Medical Device Authority (MDA)

https://www.mda.gov.my/162-medical-device-registration/343-re-registration.html

Suspension and Cancellation of Establishment Licence and Medical Device Registration News All news Safety Information The following documents are summary of some …

Apply for registration of a Refurbished Medical Device, Malaysia

https://morulaa.com/south-east-asia-medical-device-registration/medical-device-authority-manufacturer-authorized-representative-refurbished/

This Article Deals about the Submission of Medical Device Application for Registration Published by Medical Device Authority of Malaysia. This manual was created to help the …

Medical Device registration in Malaysia

https://cmsmedtech.com/medical-device-registration-in-malaysia/

Flow chart for Medical Device Registration in Malaysia FREQUENTLY ASK QUESTIONS (FAQ) 1. Do you need to appoint a local representative in Malaysia to …

Medical Device Regulatory And Approval …

https://credevo.com/articles/2022/10/15/medical-device-regulatory-and-approval-process-in-malaysia/

To register your medical device in Malaysia, first, you need to determine the medical device’s class according to Appendix I of the Medical Device …

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