Securing regulatory approval to market your medical device in the small but lucrative Singaporean market means dealing with the Health Sciences Authority, the agency responsible for overseeing medical device registration in Singapore.
Medical device regulations in Singapore are based on recommendations of the Global Harmonization Task Force (GHTF), and are similar to regulatory requirements in the EU and other GHTF markets. Classification of devices in Singapore is based on a four-tier system (Class A, B, C and D), with Class A covering lowest-risk products and Class D covering highest-risk products.
Emergo Group’s Singapore office has the expertise and resources to fully support your medical device registration. We can help you determine the proper classification of your device, prepare all necessary documentation for your registration application and provide in-country representation to manage your medical device registration process in Singapore.