Regulatory Compliance & Certifications

Global Healthcare SG is committed to quality and safety.

We’re dedicated to the highest standards of regulatory compliance, ensuring our innovative cooling solutions consistently meet global medical and safety regulations. Our products undergo rigorous testing and evaluation, ensuring performance and reliability in critical situations.

Regulatory Approvals

The CarbonCool® Full Body Suit™ adheres strictly to international regulatory guidelines, including:

  • FDA 510(k) (U.S.) – Cleared for medical use.
  • CE Marking (Europe) – Meets stringent European Union safety, health, and environmental requirements.
  • HSA Approval (Singapore) – Complies with the Health Sciences Authority of Singapore guidelines for medical devices.
  • MDA Approval (Malaysia) – Registered with Malaysia’s Medical Device Authority.
  • Thai FDA Approval (Thailand) – Certified by the Food and Drug Administration of Thailand.
  • Regulatory Clearance in Vietnam and Cambodia – Approved by local medical device regulatory bodies.