Navigating HSA Regulations for Medical Device Registration

Singapore's strategic position as a commercial hub in Asia, coupled with its high GDP per capita and robust healthcare infrastructure development, presents lucrative opportunities for overseas medical device manufacturers. With the majority of medical devices imported, Singapore's market is open to high-end innovative products.

Device Classification and Regulatory Pathways

Aligning with Singapore's HSA Requirements

Regulatory Authority

The Health Sciences Authority (HSA) of Singapore enforces the Health Products Act and corresponding regulations to ensure medical devices' quality, safety, and efficacy. With a regulatory framework aligned with the Global Harmonization Task Force (GHTF), Singapore mandates registration for Class B, C, and D medical devices, exempting only non-sterile Class A devices.

Classification

Singapore adopts a risk-based classification system for medical devices, categorizing them into Classes A, B, C, and D. This classification influences the registration requirements and the level of regulatory scrutiny applied.

Key Requirements

Manufacturers seeking entry into the Singapore market must:

  • Determine the classification of their products to identify the appropriate regulatory pathway.
  • Appoint a Registrant to manage the product registration process with the HSA, fulfilling all duties and obligations under the Health Products Act and regulations.
How We Can Help

Tailored Support for Market Entry

Our comprehensive services are designed to facilitate your regulatory compliance and market entry in Singapore:

  • Guidance on product classification and regulatory pathway determination.

  • Compilation of the technical dossier required for HSA registration.

  • Representation as your Registrant, handling HSA submission and post-market compliance. As a GDPMDS certified entity, we can also serve as your importer for exempted Class A products.

We Provide Access To 28+ Markets Worldwide

Our team of experts and local representatives, supported by partnerships with hundreds of clinical labs and the extensive GRIP database for over 100 countries, accelerates product launches and ensures compliance across 28 countries.

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