The Medical Device Authority (MDA), in collaboration with the Universiti Malaya (UM) research team, is conducting a study titled “Barriers, Risks, and Regulations in Malaysia’s Medical Device Industry”.
Scope
Summary of the online survey conducted jointly by the Medical Device Authority (MDA) and Universiti Malaya (UM) to identify barriers, risks, and opportunities within Malaysia’s medical device sector.
Key Highlights
Purpose of the Study
- To identify barriers and risks influencing the growth and competitiveness of Malaysia’s medical device industry.
- To explore strategies for improving local capabilities and reducing reliance on imported high-tech devices.
Background
The medical device industry has been recognized as a priority sector under the New Industrial Master Plan (NIMP) 2030 due to its potential for innovation and export growth.
The study aims to support Malaysia’s efforts toward a more resilient and self-sustaining medical device ecosystem.
Survey Participation
- Open to all licensed establishments and medical device stakeholders.
- Participation is voluntary, with no monetary compensation.
- All data collected will remain anonymous and confidential.
- Survey form link: https://forms.gle/vHhUW92MNCYpesXQ6
Survey Structure
- Section A: Company Profile
- Section B: Internal Barriers, Trade Barriers, and External Risks
- Section C: Supply Chain Linkages and Disruptions
- Section D: Streamlining Regulation and Driving Innovation
Ethics Approval
- Universiti Malaya Research Ethics Committee (UMREC): UM.TNC(P&I)/UMREC_5305
Implications to Clients
Stakeholders are strongly encouraged to participate in the online survey to share their insights and experiences. Feedback will directly support MDA in developing more effective and practical regulatory policies for the medical device sector.
Industry participation will help identify challenges, strengthen supply chain resilience, and promote innovation in the local ecosystem. The survey results may influence future regulatory adjustments and initiatives under the NIMP 2030 framework.
Effective Date
Ongoing — survey open from 17 October 2025 until further notice.
Contact Us
Contact us at sales@andamanmed.com for guidance, or click the button below for support in Malaysia.
