Market potential

With a population of 5+ million, Singapore has the highest GDP per capita in Asia, according to Trading Economics. Not surprisingly, its medical device market is one of the largest and most advanced in Southeast Asia and is welcoming of high-end innovative products. Indeed, many famous medical device MNCs have their regional headquarters in Singapore. According to a report by Mordor Intelligence, the market size was valued at USD 1.5 billion in 2020 and is expected to reach USD 2.3 billion by 2026, with a CAGR of 7.2% during the forecast period (2021-2026).

This growth is primarily driven by several factors, including the Singapore’s ageing population, the increasing prevalence of chronic diseases, and the government's efforts to promote the development of its healthcare infrastructure. Indeed, there will be at least 8 new nursing homes that will be built within the next 5 years, as well as 10 polyclinics and a new hospital that are slated to be completed by 2030. Given its small land area, there are few factories so it has to import most of its medical devices, presenting opportunities for overseas manufacturers.

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 in Singapore. We start with the classification and grouping of your products to determine the regulatory requirements and, when you decide to move forward, will compile the technical file for you.

We can do the submission to HSA as your local representative and support you with any post-market follow up activities as needed for continuous regulatory and commercial success.

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