HSA Singapore 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.
Aligning with Singapore's HSA Requirements
Regulatory Authority
Pure Global can assist with Singapore's medical device registration, ensuring HSA approval to sell in the Singaporean market.
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.
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.
Let's Talk,
Anywhere You Are.
Whether looking for more information or ready to partner with us, we're here to guide you through every step of the regulatory process.