Market potential

With a population of over 5 million, Singapore boasts the highest GDP per capita in Asia, according to Trading Economics. Its medical device market is one of the largest and most advanced in Southeast Asia, making it an ideal destination for high-end innovative products. Many renowned medical device multinational corporations have established their regional headquarters in Singapore. According to a report by Mordor Intelligence, the market was valued at USD 1.5 billion in 2020 and is expected to grow to USD 2.3 billion by 2026, with a CAGR of 7.2% during the forecast period (2021-2026). This impressive growth is fueled by Singapore's aging population, the rising prevalence of chronic diseases, and the government's initiatives to expand its healthcare infrastructure. Over the next five years, at least eight new nursing homes, 10 polyclinics, and a new hospital are planned, with more developments anticipated by 2030.

Due to its small land area and limited local manufacturing, Singapore imports the majority of its medical devices, offering significant opportunities for overseas manufacturers. For companies looking to tap into this growing market, expert guidance is essential. Our medical device regulatory consulting services provide the support needed to navigate Singapore’s regulatory environment, ensuring smooth market entry and long-term success in this thriving market.

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Overview of the regulatory system

Medical devices are regulated under the Health Products Act and Health Products (Medical Devices) regulations.  Singapore’s Health Sciences Authority (HSA) oversees the system of statutory control aimed to safeguard the quality, safety, and efficacy of medical devices available in Singapore.  Almost all medical devices are regulated.  Class A medical devices supplied in a non-sterile state are exempted, however, Class B, C, and D medical devices are subject to product registration requirements.  Classification rules are adopted from the guidance developed by the Global Harmonization Task Force (GHTF).

Product registration is done by a “registrant”, defined as a person or company who applied for and obtained the registration of the medical device under the Health Products Act.. A registrant of a medical device has to fulfil the duties and obligations prescribed under the Act and Health Products (Medical Devices) Regulations.

Singapore – Gateway to Southeast Asia’s 600+ million population

Although small in size,  Singapore’s competitive advantage such as a highly skilled labour force, and high quality physical and digital infrastructure makes it well known in SEA and beyond. Indeed, it is for such reasons that Singapore was chosen to house the Southeast Asia (SEA) headquarters of Pure Global. By working with a single point of contact in Singapore, you will be able to simultaneously register your medical device in the 6 major SEA markets – Singapore, Malaysia, Indonesia, Thailand, Vietnam and Philippines. This saves you invaluable time and gains you speedy access to the 600+ million SEA market.

How can we help you?

We offer a full range of market access services, including HSA Singapore Medical Device Registration. Our process begins with the classification and grouping of your products to determine the specific regulatory requirements. Once you're ready to proceed, we will compile the technical file and ensure all necessary documentation is in order. As your local representative, we handle the submission to the HSA for Singapore Medical Device Registration and provide ongoing support with any post-market follow-up activities needed to ensure continuous regulatory compliance and commercial success.

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