Medical Device Registration & Compliance
Need medical device registration in Singapore? Syndesia helps overseas companies with HSA approval, ISO 13485, GDPMDS certification & regulatory compliance. Faster market entry, less hassle.
Why Overseas Medtech Companies Struggle in Singapore
• Unclear regulatory pathways under HSA.
• Lengthy and confusing documentation requirements.
• ISO 13485 and GDPMDS setup without local guidance.
• Costly delays from rejected or incomplete submissions.
Don’t lose time to regulatory hurdles! Syndesia helps you cut through the complexity.
End-to-End Services
1. Medical Device Product Registration (HSA)
o Device classification & pathway assessment
o Dossier preparation & submission
o Communication with HSA regulators
o Ongoing post-market compliance
2. ISO 13485 Implementation
o Tailored QMS design & implementation
o SOPs & documentation support
o Audit preparation & certification readiness
3. GDPMDS Certification Support
o Gap analysis & compliance roadmap
o Distribution & storage documentation
o Staff training for long-term compliance
4. Gap Analysis & Compliance Roadmap
o Detailed review of current processes
o Identify compliance gaps early
o Prioritized action plan for smooth registration
Why Choose Syndesia
Your Trusted Partner in Singapore’s Regulatory Landscape
✅ Local expertise with international standards
✅ Faster market access, fewer rejections
✅ Tailored solutions for overseas companies entering SEA
With Syndesia, compliance becomes a growth enabler; not a barrier.
Ready to Register Your Medical Device in Singapore?
Don’t let regulations slow your innovation. Partner with Syndesia for HSA registration, ISO 13485 certification, and GDPMDS compliance! Get it done right, the first time!
Contact: QARA@syndesia.com