PENGUMUMAN 

PELAKSANAAN SURAT PEKELILING PIHAK BERKUASA PERANTI PERUBATAN BILANGAN 1 TAHUN 2025: PENILAIAN PEMATUHAN BAGI PERANTI PERUBATAN YANG TELAH DILULUSKAN PIHAK BERKUASA NEGARA LAIN YANG DIIKTIRAF

 

Pihak Berkuasa Peranti Perubatan (Medical Device Authority – MDA) ingin memaklumkan bahawa MDA telah membuat pindaan terhadap Surat Pekeliling Pihak Berkuasa Peranti Perubatan Bilangan 2 Tahun 2014 - Conformity Assessment Procedures for Medical Device Approved by Recognised Countries. Surat pekeliling ini digantikan dengan surat pekeliling baru iaitu Surat Pekeliling Pihak Berkuasa Peranti Perubatan Bilangan 1 Tahun 2025 - Conformity Assessment Procedures for Medical Device Approved by Recognised Countries (Surat Pekeliling) yang telah diluluskan oleh Anggota dan Pengurusan Tertinggi MDA. Surat Pekeliling ini akan mula berkuatkuasa  pada 11 Mac 2025.

Seiring dengan penguatkuasaan Surat Pekeliling ini, dua dokumen panduan kepada pihak badan penilaian pematuhan (conformity assessment body – CAB) dan establismen untuk menerangkan tatacara penilaian pematuhan bagi peranti perubatan yang telah memperoleh kelulusan daripada pihak berkuasa di negara-negara yang telah diiktiraf seperti berikut;

  1. MDA/GD/0068 - GUIDE FOR CONFORMITY ASSESSMENT BODIES (CAB): CONDUCTING CONFORMITY ASSESSMENT THROUGH VERIFICATION 
  2. MDA/GD/0070 - GUIDE FOR MEDICAL DEVICE ESTABLISHMENT: CONFORMITY ASSESSMENT BY WAY OF VERIFICATION & SUBMISSION OF MEDICAL DEVICE REGISTRATION IN MeDC@St>

Sehubungan dengan itu, Surat Pekeliling ini hendaklah dibaca bersekali dengan kedua-dua dokumen panduan yang dinyatakan di atas. Dengan penyiaran Surat Pekeliling ini juga, maka Surat Pekeliling MDA Bilangan 2 Tahun 2014 adalah terbatal.

Dokumen-dokumen berkaitan pelaksanaan dan penguatkuasaan dasar ini boleh dimuat turun dari laman sesawang MDA menerusi pautan yang disediakan. Sebarang pertanyaan boleh diajukan melalui MDA Feedback Management System (FEMES).

Sekian, terima kasih.

Ketua Eksekutif

Pihak Berkuasa Peranti Perubatan

26 Mac 2025

 

____________________________________________________________________________________________________________________________________________________________________

ANNOUNCEMENT

 

IMPLEMENTATION OF CIRCULAR LETTER OF THE MEDICAL DEVICE AUTHORITY NO. 1 YEAR 2025: CONFORMITY ASSESSMENT PROCEDURES FOR MEDICAL DEVICE APPROVED BY RECOGNISED COUNTRIES

 

Medical Device Authority (MDA) wishes to inform that amendments have been made to Circular Letter of the Medical Device Authority Number 2 Year 2014 - Conformity Assessment Procedures for Medical Devices Approved by Recognised Countries. This circular letter has been replaced with a new circular letter, Circular Letter of the Medical Device Authority Number 1 Year 2025 - Conformity Assessment Procedures for Medical Devices Approved by Recognised Countries (Circular Letter), which has been approved by the Board and Top Management of MDA. This Circular Letter shall come into effect on 11 March 2025.

In conjunction with the enforcement of this Circular Letter, two guidance documents have been prepared for conformity assessment bodies (CABs) and establishments to outline the procedures for conformity assessment of medical devices approved by recognised foreign regulatory authorities, as follows:

  1. MDA/GD/0068 - GUIDE FOR CONFORMITY ASSESSMENT BODIES (CAB): CONDUCTING CONFORMITY ASSESSMENT THROUGH VERIFICATION
  2. MDA/GD/0070 - GUIDE FOR MEDICAL DEVICE ESTABLISHMENT: CONFORMITY ASSESSMENT BY WAY OF VERIFICATION & SUBMISSION OF MEDICAL DEVICE REGISTRATION IN MeDC@St>

Accordingly, this Circular Letter shall be read in conjunction with both of the above guidance documents. Furthermore, with the issuance of this Circular Letter, Circular Letter of the Medical Device Authority Number 2 Year 2014 is hereby revoked.

The relevant documents regarding the implementation and enforcement of this policy can be downloaded from the MDA website portal via the provided links. Any inquiries may be directed through the MDA Feedback Management System (FEMES).

 

Thank you.

Chief Executive

Medical Device Authority

26 March 2025