Malaysia
Medical Device Market Size
Market Value: As of 2024, Malaysia’s medical device market is estimated at USD 2.1 billion, supported by its position as a leading manufacturing hub in Southeast Asia.
Growth Projections: Expected to reach USD 2.6 billion by 2029, with a CAGR of approximately 4.3%.
Future Growth Potential
- Export-Oriented Industry: Malaysia is a major exporter of medical gloves, catheters, and diagnostic equipment.
- Public-Private Investments: Continuous investments in public and private healthcare infrastructure are expanding the demand for advanced devices.
- Aging Population & NCDs: Increasing elderly population and prevalence of non-communicable diseases are driving medical device usage.
Registration Process
Regulatory Authority: Medical Device Authority (MDA), under the Ministry of Health.
Device Classification:
- Class A — Low Risk
- Class B — Low to Moderate Risk
- Class C — Moderate to High Risk
- Class D — High Risk
Registration Requirements:
- Class A Devices: Require notification and can be self-declared.
- Class B, C, D Devices: Require certification through a Conformity Assessment Body (CAB) before registration.
Local Representation: Foreign manufacturers must appoint a Local Authorized Representative (LAR) registered in Malaysia.
Quality Management: ISO 13 485 is mandatory for all manufacturers. CABs assess conformity and conduct audits as part of the registration.
Online Portal: MeDC@St (Medical Device Centralized Online Application System) — https://mdast.mda.gov.my
Language Requirements: Labeling and Instructions for Use (IFU) must be in Bahasa Malaysia or English.
Post-Market Surveillance: Requires vigilance reporting, complaint handling, and mandatory adverse event reporting.