Indonesia
Indonesia is one of the largest medical device markets in Southeast Asia, with growing demand driven by the expansion of the healthcare system.
Do you require help or further information?
Contact us! We are happy to advise you:
Regulatory Framework
The competent authority is the Ministry of Health (MoH).
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 Indonesian or English. |
| Local Representative | Mandatory for foreign manufacturers. |
| Certifications | CE, FDA, and ISO 13485 facilitate the process. |
Challenges and Operational Advice
- Complex regulatory pathway: Timelines may vary depending on the device category.
- Language requirements: Full translation of documents into Indonesian is required.
Why Choose ISEMED
- ASEAN Experience
In-depth knowledge of Indonesian regulations. - Strategic Support
Comprehensive assistance from dossier preparation to registration.
FAQ
- Is a local representative required? Yes.
- Documentation language? Indonesian or English.
- License duration? 5 years.