Malaysia
Malaysia is one of the most dynamic markets in Southeast Asia, with increasing investments in healthcare and strong demand for imported medical devices.
Do you require help or further information?
Contact us! We are happy to advise you:
Regulatory Framework
The competent authority is the Medical Device Authority (MDA) under the Ministry of Health.
Device Classification:
- Class A: Low risk
- Class B: Moderate risk
- Class C: High risk
- Class D: Very high risk
Specific Local Requirements
| Language | Documentation in English or Malay. |
| Local Representative | Required for foreign manufacturers. |
| Certifications | CE, FDA, and ISO 13485 certifications facilitate the process. |
Challenges and Operational Advice
- Digitalization: Mandatory use of the MeDC@St portal for process management.
- Complex process: Review times vary, especially for Class C and D devices.
Why Choose ISEMED
- ASEAN Experience
Expertise in the region’s regulatory processes. - Ongoing Support
Assistance with portal use and interaction with authorities.
FAQ
- Is a local representative required? Yes.
- Documentation language? English or Malay.
- License duration? 5 years.