Singapore’s Health Sciences Authority (HSA) requires foreign medical device manufacturers with no local presence in the country to appoint an in-country regulatory representative (Registrant) to manage their product registrations.
Your Singapore Registrant must be a company based in Singapore and registered with the HSA. In addition, your Registrant must hold Accounting and Regulatory (ACRA) registration.
Responsibilities carried out by your Singapore Registrant include filing your medical device registration application with the HSA, as well as managing all post-market activities involving your device in the Singaporean market, such as complaint handling, record keeping and corrective actions.
Emergo maintains offices in Singapore, and can act on your behalf as your Singapore Registrant dealing with the HSA.
Please contact us for more information about in-country representation in Singapore.