How to Register a Medical Device in Singapore

This video gives medical device manufacturers a clear, step-by-step look at how to enter Singapore’s fast-growing medical technology market. It explains why Singapore has become a global hub for high-end medtech innovation and outlines the regulatory pathway managed by the Health Sciences Authority (HSA), from device classification and dossier requirements to the mandatory appointment of a local Registrant.

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Topics covered in this video include:

• Market trends shaping Singapore’s medtech and IVD sectors
• The HSA’s four-tier medical device classification system
• Documentation, labeling, and post-market vigilance requirements
• The importance of appointing a local Registrant to ensure compliance
• How Pure Global streamlines your Singapore market entry

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Singapore is strategically positioned as Asia’s premier gateway for medical devices, with world-class logistics, a highly developed healthcare infrastructure, and one of the highest GDPs per capita worldwide. By 2029, the medical device market is forecast to reach US $1.94 billion, with the in vitro diagnostics (IVD) segment alone valued at $222 million. Aging demographics (18% of the population is over 65) and a rapid embrace of digital and connected health technologies are driving demand. For global manufacturers, securing HSA approval is the key to accessing not just Singapore, but a network of regional opportunities across Asia-Pacific.

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The regulatory framework in Singapore uses a risk-based classification system with four classes: Class A (low risk), Class B, Class C, and Class D (highest risk). The classification determines documentation and evidence requirements, labeling expectations, and whether the product is eligible for expedited review. All foreign manufacturers must appoint a local Registrant to manage their HSA submissions, act as the legal point of contact with the authority, facilitate customs clearance, and maintain post-market surveillance duties. Without a Registrant, it is not possible to import or distribute devices in Singapore.

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Need HSA approval?
Pure Global’s Singapore-based regulatory team uses AI-enabled tools to shorten submission timelines and ensure complete, accurate filings. From classification and GDPMDS importation to post-market vigilance, our process is designed to help you launch quickly while maintaining long-term compliance. Contact Pure Global for help with Singapore medical device registration.

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