ANNOUNCEMENT: REGISTRATION STATUS OF MEDCERT MALAYSIA SDN. BHD. AS A CONFORMITY ASSESSMENT BODY (CAB) UNDER ACT 737
ANNOUNCEMENT:
REGISTRATION STATUS OF MEDCERT MALAYSIA SDN. BHD.
AS A CONFORMITY ASSESSMENT BODY (CAB) UNDER ACT 737
DATE OF ANNOUNCEMENT: 7 NOVEMBER 2025
Medical Device Authority (MDA) wishes to inform all stakeholders and the public that MEDCERT MALAYSIA SDN. BHD. (MMSB), a registered Conformity Assessment Body (CAB) under Act 737 with registration number MDA/CAB-002, is currently undergoing a Members’ Voluntary Liquidation.
Following notification from the appointed Joint and Several Liquidators, MDA acknowledges that MMSB has ceased operations effective 29 August 2025. Consequently, all regulatory activities, including conformity assessment services previously conducted by MMSB, have been discontinued.
Key points for stakeholders’ attention:
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CAB Registration Expiry: MMSB’s CAB registration (MDA/CAB-002) remains valid until 20 November 2025. The registration will not be renewed thereafter. MMSB’s CAB registration (MDA/CAB-002) is scheduled to expire on 20th November 2025. However, as MMSB has ceased operations and right now is undergoing Member’s Voluntary Liquidation, it is no longer authorised to conduct any conformity assessment activities. The registration will not be renewed thereafter. |
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Impact on Certification Holders: All medical device establishments and clients previously certified or assessed by MMSB are required to transfer their certifications to another CAB registered with MDA to maintain compliance with the Medical Device Act 2012 (Act 737) and its subsidiary regulations. Clients are advised to initiate transfer arrangements as early as possible to avoid disruption in regulatory compliance and business operations. |
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Stakeholder Advisory Medical device establishments must ensure that their certifications remain valid and are issued by an active CAB registered under Act 737. MDA will continue to recognise certificates or approvals issued by MMSB prior to its cessation of operations until the respective certificates or approvals reach their original expiry date. |
For further information or assistance regarding this matter, stakeholders may contact the Conformity Assessment Body Registration Unit (CABRU), Pre-Market Controls Division, MDA via email at [email protected] or by telephone at +603-82300 352/374/394/238.
Issued by:
CABRU
Pre-Market Controls Division (BKPP)
Medical Device Authority (MDA)
Uploaded by : Corporate Communication Division
Date : 7/11/2025
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PENGUMUMAN: STATUS PENDAFTARAN MEDCERT MALAYSIA SDN. BHD. SEBAGAI BADAN PENILAIAN PEMATUHAN (CAB) DI BAWAH AKTA 737
TARIKH PENGUMUMAN: 7 NOVEMBER 2025
Pihak Berkuasa Peranti Perubatan (MDA) ingin memaklumkan bahawa MEDCERT MALAYSIA SDN. BHD. (MMSB) iaitu sebuah Badan Penilaian Pematuhan (CAB) yang berdaftar di bawah Akta Peranti Perubatan 2012 [Akta 737] dengan nombor pendaftaran MDA/CAB-002, kini sedang melalui proses Penggulungan Sukarela oleh Ahli.
Dimaklumkan bahawa Pelikuidasi-Pelikuidasi Bersesama dan Berasingan bagi MMSB mengesahkan bahawa MMSB telah menamatkan operasi berkuat kuasa mulai tarikh 29 Ogos 2025. Sehubungan itu, semua aktiviti regulatori termasuk perkhidmatan penilaian pematuhan yang dijalankan oleh MMSB adalah diberhentikan sepenuhnya.
Berikut adalah perincian berkaitan;
1. Tempoh Sah Pendaftaran CAB
Pendaftaran MMSB sebagai CAB (MDA/CAB-002) adalah tamat pada 20 November 2025. Namun demikian, MMSB tidak lagi dibenarkan menjalankan sebarang aktiviti penilaian pematuhan di bawah Akta 737 memandangkan MMSB telah menghentikan operasi dan sedang melalui proses penggulungan sukarela. Pendaftaran MMSB tidak akan diperbaharui selepas tamat tempoh berkenaan.
2. Kesan kepada Pemegang Sijil
Semua establismen yang mendapatkan sijil dan laporan yang dikeluarkan oleh MMSB hendaklah memindahkan pensijilan mereka kepada mana-mana CAB lain yang berdaftar dengan MDA bagi memastikan pematuhan berterusan terhadap Akta 737 dan peraturan-peraturan dibawahnya. Establismen dinasihatkan supaya memulakan proses pemindahan dengan segera bagi mengelakkan sebarang kesulitan terhadap pematuhan Akta 737.
3. Nasihat kepada Pihak Berkepentingan
Semua establismen hendaklah memastikan bahawa pensijilan mereka masih sah dan dikeluarkan oleh CAB yang aktif di bawah Akta 737. MDA akan menerima sijil dan laporan yang dikeluarkan oleh MMSB sebelum tarikh penghentian operasi iaitu 28 Ogos 2025 sehingga tarikh tamat sijil atau kelulusan berkenaan.
Untuk sebarang pertanyaan lanjut, sila hubungi Unit Pendaftaran Badan Penilaian Pematuhan (CABRU) melalui emel di [email protected] atau telefon di talian +603-8230 0352/ 0374 / 0394 / 0238.
Dikeluarkan oleh:
CABRU
Bahagian Kawalan Pra-Pasaran (BKPP)
Pihak Berkuasa Peranti Perubatan (MDA)
Dimuatnaik oleh: Bahagian Komunikasi Korporat
Tarikh : 7/11/2025
