A) INTERNATIONAL RELATIONS BRANCH:

• Bilateral Cooperation Unit

• Multilateral Cooperation Unit

Brief Introduction:

The International Relations Branch is one of the branches under the International and Industry Relations Division (BHAI). There are two units under this branch: the Bilateral Cooperation Unit and the Multilateral Cooperation Unit, which play a key role in coordinating MDA’s relationships and cooperation with foreign countries and international agencies.

The functions and objectives of the International Relations Branch include:

i. Establishing strategic cooperation and strengthening relationships through bilateral, regional, and multilateral collaborations at the international level related to medical devices.

ii. Building cooperative relationships with international organisations relevant to the medical device sector, such as WHO, WTO, ASEAN, ACCSQ, GHWP, APEC, IMDRF, ISO, IEC, and others.

iii. Planning and managing activities related to Memoranda of Understanding (MOU), Memoranda of Agreement (MOA), and Mutual Recognition Arrangements (MRA) with relevant authorities and organisations at the international level.

iv. Coordinating the provision of inputs and exchange of information related to medical device regulatory activities and the medical device industry at the international level to the Ministry of Health (KKM), relevant ministries, authorities, and related organisations both locally and internationally.

v. Coordinating MDA’s participation in meetings related to medical device regulatory activities and cooperation at the international level organised by KKM, relevant ministries, authorities, and international organisations.

vi. Coordinating MDA’s participation in the development of international technical regulations and standards through relevant committees at the international level.

vii. Coordinating MDA’s membership in international committees related to medical device regulation.

viii. Coordinating MDA’s participation in seminars, conferences, forums, dialogues, and meetings at the international level.

B) INDUSTRY FACILITATION BRANCH

Brief Introduction

The Industry Facilitation Branch is a key branch under the International and Industry Relations Division (BHAI), responsible for implementing various strategic functions to drive the growth and development of the medical device sector. The Industry Facilitation Branch comprises three units:
i. Exemption Unit;
ii. Industry Assistance Unit; and
iii. e-Permit Unit.

The main roles of this branch include:

a) Developing and strengthening the structure and role of industry-related organisations – Supporting the establishment and improvement of organisational frameworks involving the medical device ecosystem to ensure sustainable and competitive development.

b) Identifying and examining regulatory issues – Monitoring and addressing regulatory challenges and issues that affect the growth of the medical device industry, to ensure compliance with established safety and quality standards.

c) Enhancing service delivery efficiency – Facilitating, supporting, and promoting innovation and growth in the medical device industry through the provision of efficient and industry-friendly services.

This branch plays a critical role in strengthening strategic relationships among stakeholders and contributes to enhancing the competitiveness of the medical device industry at both national and international levels.

Prepared by: International and Industry Relations Division 

Uploaded by: Corporate Communication Division

Date of upload: 12/11/2025

The Policy and Strategic Planning Division of MDA plays a vital role in formulating and coordinating policies and strategies related to the regulation of medical devices in Malaysia. The functions of this division include:

Technology Assessment & Evaluation Unit

• Conducts regulatory studies and technology assessments to enhance the control of medical devices.

Guidance Document Unit

• Plans, coordinates, and publishes guidance documents to ensure understanding and compliance with regulations.

Policy & Regulatory Unit

• Plans and coordinates policy amendments and regulatory implementation strategies under Act 737.

Strategic Planning Coordination Unit

• Monitors the achievement of MDA’s strategic plans and coordinates planning and certification activities.

Usage & Healthcare Facility Unit

• Develops competency programs, conducts inspections of healthcare facilities, and manages medical device permits.

Inter-Agency & Collaboration Unit

• Manages strategic collaborations with agencies within and outside the Ministry, and coordinates partnerships with stakeholders.

Prepared by: Policy and Strategic Planning Division 

Uploaded by: Corporate Communication Division 

Date of upload: 12/11/2025

BAHAGIAN PASCA PASARAN & PENGUATKUASAAN

1. Fungsi Cawangan Vigilan dan Pemantauan

• Menilai dan mengesahkan aduan berkaitan keselamata dan prestasi peranti perubatan yang diterima daripada pengguna dan orang awam
• Menjalankan siasatan terhadap aduan, pelaporan insiden yang berkaitan dengan isu keselamatan dan prestasi peranti perubatan.
• Menilai Pelaporan Masalah Mandatori (MPR) dan meluluskan penutupan (closure) laporan MPR.
• Menilai notifikasi Tindakan Pembetulan atau Pencegahan di Lapangan (FCA) dan meluluskan penutupan (closure) laporan FCA.
• Menilai notifikasi Panggilan Balik (Recall) dan meluluskan meluluskan penutupan (closure) laporan Panggilan Balik.
• Menjalankan pemeriksaan dan mengesahkan kepatuhan terhadap keperluan perundangan dan standard berkaitan pemantauan dan pengawasan pascapasaran oleh establismen.
• Menjalankan pengujian peranti perubatan dalam pasaran untuk mengesahkan keselamatan dan prestasi peranti perubatan
• Menyelaras sebaran maklumat secara berkala berkaitan keselamatan dan prestasi peranti perubatan di peringkat pascapasaran serta tindakan pembetulan dan pencegahan di lapangan
• Pemantauan terhadap establismen untuk memastikan establismen mematuhi keperluan Akta 737 dan Peraturan dibawahnya secara berterusan
• Pemantauan pasaran untuk memastikan hanya peranti perubatan berdaftar diletakkan dalam pasaran
• Pemantuan penjualan secara dalam talian untuk memastikan hanya peranti perubatan berdaftar dijual secara dalam talian
• Pemantauan iklan untuk memastikan hanya iklan peranti perubatan yang diluluskan di siarkan
• Kawalan pintu masuk dengan kerjasama agensi penguatkuasa di pintu masuk untuk memastikan hanya pengimport berlesen mengimport peranti perubatan berdaftar ke Malaysia

2.  Fungsi Cawangan Risikan & Siasatan

• Mengesahkan aduan pelanggaran undang-undang di bawah Akta 737.
• Melakukan risikan dan profiling untuk mengumpul bukti pelanggaran undang-undang.
• Melaksanakan serbuan dan geledah untuk kes pelanggaran undang-undang.
• Melakukan siasatan dan pengumpulan maklumat bagi kes pelanggaran undang-undang.
• Melaksanakan analisis forensik terhadap barang rampasan termasuk maklumat digital.
• Melakukan pemeriksaan ke atas individu yang terlibat dalam kes pelanggaran undang-undang.
• Melaksanakan pendakwaan termasuk penyediaan kertas pertuduhan dan pengurusan dokumen mahkamah.
• Menguruskan ekshibit bagi memastikan integriti bukti terjaga.
• Melakukan kawalan pintu masuk.

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