On March 9, 2026, the Medical Device Authority (MDA), Ministry of Health Malaysia, announced the implementation of the Innovative Medical Device Review Pathway to support the development and regulatory readiness of innovative medical devices in Malaysia. The initiative aligns with the New Industrial Master Plan (NIMP) 2030 and aims to foster collaboration between government, academia, and industry.
Read the official announcement here: [PDF]
Key Highlights
MDA currently offers the Innovative Medical Devices Review Service, providing regulatory advisory on the Essential Principles of Safety and Performance (EPSP):
- Early Development Review (TRL 3–5): RM 1,000 per 2-hour session
- Pre-commercial Review (TRL 6–9): RM 1,500 per 2-hour session
This service helps innovators understand regulatory requirements and prepare for market access in Malaysia.
Implications to Clients
Medical device manufacturers and innovators developing novel technologies may:
- Benefit from early regulatory guidance to reduce development risks
- Improve alignment with Essential Principles of Safety and Performance (EPSP)
- Enhance preparedness for product registration and market entry in Malaysia
Effective Date
The implementation of the Innovative Medical Device Review Pathway is effective immediately.
For Inquiries
For inquiries or support regarding medical device regulatory requirements in Malaysia, please contact sales@andamanmed.com.
