A) INTERNATIONAL RELATIONS BRANCH:

  • Bilateral Cooperation Unit

  • Multilateral Cooperation Unit

1. 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

1. 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