Singapore
Singapore is a strategic hub for the Asian market, with high healthcare standards and a strong openness to innovation.
Do you require help or further information?
Contact us! We are happy to advise you:
Regulatory Framework
The competent authority is the Health Sciences Authority (HSA).
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. |
| Local Representative | Required for foreign companies. |
| Certifications | Added value for devices already approved in the EU, USA, Japan; ISO 13485. |
Challenges and Operational Advice
- ASEAN Agreement: Partial harmonization with neighboring countries.
- Online registration: The MEDICS system is efficient but has strict timelines.
Why Choose ISEMED
- ASEAN Experience
Targeted support for entering Southeast Asian markets. - Comprehensive Assistance
From dossier submission to post-market support.
FAQ
- Is a local representative required? Yes.
- Documentation language? English.
- License duration? 1 year.