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, the market is open to manufacturers of high-end innovative products medical device registration in Singapore.
Singapore’s medical devices market will reach $1.94B by 2029 (8.35% CAGR), while the IVD market grows to $222.5M (5.47% CAGR). Growth is driven by tech advancements, rising chronic diseases, and an aging population (18.4% 65+ in 2022).
Medical devices sold in Singapore are regulated by the Health Sciences Authority (HSA). Pure Global can assist with Singapore's medical device registration and act as your Registrant, ensuring HSA approval to sell in the Singaporean market.
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.
Manufacturers seeking entry into the Singapore market must:
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.
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. The market is open to high-end innovative products, with the majority of medical devices being imported, making Singapore medical device registration essential for market entry.
The Health Sciences Authority (HSA) is responsible for regulating medical devices in Singapore. Pure Global can assist with medical device registration in Singapore, ensuring HSA approval to sell in the Singaporean market.
Singapore adopts a risk-based classification system for medical devices, categorizing them into Classes A, B, C, and D. This classification influences the requirements for the Singapore medical device register and the level of regulatory scrutiny applied to each device.
Manufacturers seeking entry into the Singapore market must determine the classification of their products to identify the appropriate regulatory pathway under Singapore medical device regulations. Additionally, they must appoint a Registrant to manage the product registration process with the HSA, fulfilling all duties and obligations under the Health Products Act and regulations.
When you partner with Pure Global, a single registration process opens doors to multiple countries. Our global subsidiaries make this streamlined path possible.
Whether looking for more information or ready to partner with us, we're here to guide you through every step of the regulatory process.
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