Pihak Berkuasa Peranti Perubatan (Medical Device Authority – MDA) ingin memaklumkan bahawa pindaan kecil terhadap Surat Pekeliling Pihak Berkuasa Peranti Perubatan Bilangan 1 Tahun 2025 telah diluluskan dan kini surat pekeliling tersebut dirujuk sebagai Surat Pekeliling Pihak Berkuasa Peranti Perubatan Bilangan 2 Tahun 2025 (Surat Pekeliling). Surat Pekeliling ini berkuatkuasa bermula 30 September 2025.

 

Pindaan terhadap surat tersebut dibuat bertujuan untuk memaklumkan penetapan dasar menerima pakai kelulusan pra pasaran yang dikeluarkan oleh Health Science Authority, Singapura (HSA) dan Food and Drug Administration, Thailand (Thailand FDA) untuk melayakkan senarai kelulusan peranti perubatan melalui penilaian pematuhan melalui proses verifikasi. Seiring dengan Surat Pekeliling ini juga, senarai baharu kelulusan kelulusan pra pasaran peranti perubatan daripada pihak berkuasa negara yang diiktiraf oleh MDA telah dikemaskini dalam dokumen panduan MDA/GD/0068 – Guide For Conformity Assessment Body (CAB): Conducting Conformity Assessment Through Verification (Dokumen Panduan). Sehubungan dengan itu, dasar Surat Pekeliling ini hendaklah dibaca bersekali dengan Dokumen Panduan yang dinyatakan di atas, termasuk sebarang pindaan atau semakan pada masa hadapan. Dengan terbitnya Surat Pekeliling ini juga, maka Surat Pekeliling MDA Bilangan 1 Tahun 2025 adalah terbatal.

 

Dokumen-dokumen berkaitan pelaksanaan dan penguatkuasaan dasar ini boleh dimuat turun dari laman sesawang MDA menerusi pautan yang disediakan berikut:

Sekian, terima kasih.

Ketua Eksekutif

Pihak Berkuasa Peranti Perubatan

15 Oktober 2025

 

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ANNOUNCEMENT

 

CIRCULAR LETTER OF THE MEDICAL DEVICE AUTHORITY NO. 2 YEAR 2025: CONFORMITY ASSESSMENT PROCEDURES FOR MEDICAL DEVICE APPROVED BY RECOGNISED COUNTRIES

 

Medical Device Authority (MDA) wishes to inform that a minor amendment to the Circular Letter of the Medical Device Authority No. 1 Year 2025 has been approved and is now referred to as Circular Letter of the Medical Device Authority No. 2 Year 2025 (Circular Letter). This Circular Letter shall take effect from 30 September 2025.

The amendment was made to notify the adoption of pre-market approvals issued by the Health Sciences Authority, Singapore (HSA) and the Food and Drug Administration, Thailand (Thailand FDA) as qualifying approvals for medical devices eligible for conformity assessment through the verification process. In conjunction with the enforcement of this Circular Letter, an updated list of of medical device approvals by foreign regulatory authorities recognised by MDA has been specified in the guidance document MDA/GD/0068 – Guide for Conformity Assessment Body (CAB): Conducting Conformity Assessment Through Verification (Guidance Document). Therefore, the policy set forth in this Circular Letter shall be read in conjunction with the aforementioned Guidance Document, including any future amendments or revisions. Additionally, with the issuance of this Circular Letter, the Circular Letter of MDA No. 1 Year 2025 is hereby revoked.

The relevant documents for the implementation and enforcement of this policy can be downloaded from the MDA website portal via the following links:

(a) Circular Letter –  CLICK HERE; and

(b) Guidance Document –  CLICK HERE.

Thank you.

Chief Executive

Medical Device Authority

15 October 2025