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Covid-19 Recent Information

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KELULUSAN BERSYARAT BAGI KIT UJIAN KENDIRI COVD-19 / CONDITIONAL APPROVAL FOR COVID-19 SELF TEST KIT

Application form for Conditional Approval For Importation And Distribution Of Covid-19 Self Test Kit can be obtained in the following link: https://portal.mda.gov.my/industry/medical-device-registration/conditional-approval.html and in the document MDA/GL/05 (Document under revision).

Any queries and complete application should be submitted via... Read more

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). Orang awam boleh menyemak status Lesen Establismen dan pendaftaran peranti perubatan melalui carian akses di pautan https://mmdr.mda.gov.my/public/

Walau bagaimanapun, terdapat establismen yang telah melanggar Akta 737 dan Peraturan Peranti Perubatan 2012. Read more 

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Safety Information

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. Please refer to the source of information and your product supplier for details.

For Listing of Recalls & Listing of Field Safety Notice, please Click Here!

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  Pihak Berkuasa Peranti Perubatan Malaysia,
Kementerian Kesihatan Malaysia,
Aras 6, Prima 9, Prima Avenue II,
Block 3547, Persiaran APEC,
63000 Cyberjaya, Selangor, MALAYSIA

  +603 - 8230 0300
  +603 - 8230 0200 
  mdb@mda.gov.my

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  • Kemaskini Terakhir: 30 November 2021.
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