24 Ogos 2021 – Satu mesyuarat MBJ Majikan PBPP telah berlangsung buat kali yang ke-2 di pejabat Pihak Berkuasa Peranti Perubatan, Cyberjaya yang dipengerusikan oleh Ketua Eksekutif MDA, Encik Ahmad Shariff Bin Hambali.

Secara umumnya, terdapat 22 perkara yang telah dibangkitkan dalam mesyuarat tersebut, dan 17 daripadanya telah dipersetujui oleh majikan. Dalam pada itu 2 perkara masih dalam proses tindakan dan akan diangkat ke peringkat lebih tinggi untuk kelulusan, dan 3 perkara lagi masih dalam kajian dan penelitian.

Pihak Berkuasa Peranti Perubatan sentiasa berusaha untuk memberikan perhatian yang sebaiknya dalam usaha untuk mewujudkan keharmonian dan memahami kehendak para pekerja. Dikesempatan ini, PBPP ingin mengucapkan ribuan terima kasih atas komitmen dan kesungguhan yang telah dicurahkan oleh pekerja MDA sepanjang perkhidmatan. Semoga perkhidmatan yang diberikan bertambah sukses dan konsisten di masa akan datang.

The list below contains Medical Device Recall for the month of February 2022. This list provides recall reporting information to MDA by establishment in accordance to requirement stipulated in Section 42, Act 737 and Regulation 7 and 8 of Medical Device (Duties and Obligations of Establishment) Regulations 2019.

Recall is part of a post-marketing risk assessment measure to ensure the continued safe use of medical devices in the Malaysia market. Recall is any action taken by the establishment of the medical device to remove the medical device from the market or to retrieve the medical device from any person to whom it has been supplied and to notify its affected person of its defectiveness or potential defectiveness.

If you have experienced any safety and performance issue with one of the medical devices listed for Recall action, please seek advice from your healthcare professional as soon as possible.

 MEDICAL DEVICE RECALL LISTING FEBRUARY 2022

Dear Medical Device Sector Stakeholders,

IMPORTANT NOTICE: EXPIRY OF REGISTRATION FOR NEWERA INTERNATIONAL CERTIFICATION SDN. BHD. AS A CAB UNDER THE ACT 737

Greetings from the Authority. We hope this message finds you well.

We are writing to inform you about a significant development regarding a Conformity Assessment Body (CAB) registered under the Act 737, NEWERA INTERNATIONAL CERTIFICATION SDN. BHD. (Registration Number: MDA/CAB-018). As of December 17, 2023, this organization has officially expired its registration validity as a CAB.

To ensure a smooth transition for all affected clients of NEWERA INTERNATIONAL CERTIFICATION SDN. BHD., we strongly recommend the following actions:

 i.Transfer Certification to a New CAB: Affected clients are advised to promptly initiate the process of transferring their conformity assessment certificates to a new, registered CAB. This will  help maintain compliance with regulatory requirements and standards.

 ii.Engage a New CAB: Alternatively, clients may opt to engage a new CAB that meets your specific needs and regulatory obligations. It is essential to verify the registration status and eligibility of the chosen CAB before proceeding.

We understand that this situation may cause inconvenience, and we are committed to assisting you throughout this transition period. Should you have any questions or require further guidance, please do not hesitate to reach out to our dedicated support team at cab.registration@mda.gov.my.

Your commitment to maintaining the highest standards in the medical device sector is greatly appreciated. We encourage you to act promptly to ensure uninterrupted compliance and regulatory adherence. Thank you for your attention to this matter.

Best Regards,

"MALAYSIA MADANI"

"BERKHIDMAT UNTUK NEGARA"

CAB Registration Unit (CABRU)

Pre-Market Control Division (BKPP)

Medical Device Authority (MDA)

Ministry of Health (MoH)

Pihak Berkuasa Peranti Perubatan [Medical Device Authority (MDA)] akan melaksanakan penggunaan sijil pendaftaran peranti perubatan secara elektronik bermula 2 Mei 2023. Pihak establismen boleh memuat turun sijil pendaftaran peranti perubatan daripada sistem MeDC@St2.0+ setelah permohonan selesai (status complete) dan bayaran fi pendaftaran telah dijelaskan.

Kedua-dua sijil pendaftaran peranti perubatan fizikal dan elektronik boleh digunakan bagi tujuan import atau meletakkan peranti perubatan dalam pasaran Malaysia. Tempoh peralihan penggunaan sijil pendaftaran peranti perubatan fizikal kepada sijil pendaftaran peranti perubatan elektronik adalah sehingga 31 Disember 2023. Dalam tempoh peralihan ini, establismen akan menerima sijil pendaftaran peranti perubatan fizikal seperti proses sedia ada dan dalam masa yang sama sijil pendaftaran peranti perubatan elektronik boleh dimuat turun daripada sistem MeDC@St2.0+. Bagi melancarkan proses peralihan ini, establismen dikehendaki mengambil sijil pendaftaran peranti perubatan fizikal di pejabat MDA selepas 7 hari bekerja dari tarikh permohonan selesai (status complete).

Penggunaan sijil pendaftaran peranti perubatan elektronik akan dilaksanakan sepenuhnya bermula 1 Januari 2024 dan tiada lagi sijil pendaftaran peranti perubatan fizikal akan dikeluarkan oleh MDA.

Sekian, terima kasih.

Pihak Berkuasa Peranti Perubatan,

Kementerian Kesihatan Malaysia.

Tarikh dimuatnaik: 2 Mei 2023

Tarikh dikemaskini: 22 Mei 2023