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PENGUMUMAN BERKAITAN KEBENARAN BEROPERASI SEPANJANG TEMPOH PKP 3.0

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PENGUMUMAN

PENGUMUMAN BERKAITAN KEBENARAN BEROPERASI SEPANJANG TEMPOH PKP 3.0

 

Kepada semua establismen berlesen di bawah Akta 737,

Sebagaimana yang telah dimaklumkan melalui siaran media Kementerian Perdagangan Antarabangsa dan Industri (MITI) bertarikh 31 Mei 2021, https://www.miti.gov.my/redir/pkp/media.html, Pihak Berkuasa Peranti Perubatan (MDA) ingin memaklumkan bahawa semua establismen berlesen perlu mendapatkan kebenaran MITI untuk beroperasi sepanjang Perintah Kawalan Pergerakan (PKP) 3.0 bagi tempoh 1 Jun hingga 14 Jun 2021.

Sehubungan itu, Pihak Berkuasa Peranti Perubatan (MDA) ingin memaklumkan bahawa surat MDA Ruj.(70) dlm MDA-500-5/1/11 JLD 4 bertarikh 31 Mei 2021 berkaitan kebenaran operasi dan pergerakan bagi mereka yang terlibat dalam industri peranti yang telah diemailkan kepada semua establismen yang berlesen di bawah Akta 737 boleh digunakan sebagai dokumen sokongan untuk memohon kebenaran operasi dari pihak MITI melalui sistem CIMS 3.0 yang dikendalikan oleh MITI. Sila merujuk kepada MITI untuk mendapatkan penjelasan lanjut mengenai perkara ini.

Pihak Berkuasa Peranti Perubatan
Kementerian Kesihatan Malaysia
Cyberjaya
1 Jun 2021

 


 ANNOUNCEMENT

ANNOUNCEMENT FOR PERMISSION TO OPERATE DURING MOVEMENT CONTROL (MCO) 3.0

To all licensed establishments under Act 737,

Medical Device Authority Malaysia (MDA) would like to announce that all registered establishments must obtain MITI permission to operate during Movement Control Order (MC0) 3.0 from 1-14 June 2021 following to the press statement by the Ministry of International Trade and Industry (MITI) on 31st May 2021, https://www.miti.gov.my/redir/pkp/media.html.

In this regard, MDA would like to inform that MDA’s letter Ruj.(70) dlm MDA-500-5/1/11 JLD 4 dated 31st May 2021 which has been emailed to all establishments may be used as a supporting document for your application to obtain the permission to operate via MITI’s CIMS 3.0 system. Please refer to MITI for further clarification on this matter.

Medical Device Authority
Ministry of Health
Cyberjaya
1 June 2021

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  Medical Device Authority (MDA),
Ministry of Health Malaysia,
Level 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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  • Last Modified: 23 June 2021.
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