LEGAL DIVISION

Brief Introduction

The Legal Division of the Medical Device Authority (MDA) oversees all legal matters related to medical devices in Malaysia, in accordance with the Medical Device Act [Act 737] and the Medical Device Authority Act [Act 738]. Its core functions include:

i. Legal Compliance:
Formulating, reviewing, and enforcing regulatory requirements governing medical devices and related industry activities.

ii. Regulatory Management:
Developing, refining, and managing legal frameworks, including regulations on medical device registration and establishment licensing before market placement.

iii. Legal Advisory and Interpretation:
Providing legal advice and interpretations to stakeholders and industry players on matters relating to MDA-administered laws and regulations.

iv. Dispute Resolution:
Handling cases involving regulatory breaches and supporting the resolution of legal disputes within the medical device sector.

Through these functions, the Legal Unit ensures that medical devices in the Malaysian market are safe, effective, compliant with established standards, and aligned with all applicable legal requirements.

 

Prepared by: Legal Division

Uploaded by: Corporate Communication Division

Date of Upload: 14/11/2025