ANSWERED ON THIS PAGE:
- What are the responsibilities of a Singapore Registrant?
- What are the requirements for a Singapore Registrant?
- What is the difference between a Registrant and a Licensed Importer?
Singapore's Health Sciences Authority (HSA) requires foreign medical device manufacturers with no presence in the country to appoint an in-country regulatory representative (Registrant) to manage their product registrations. Your registrant is critical to your device registration and success in the Singapore market, so it is important to consider your choice carefully.
The role of a Singapore Registrant
Your Singapore Registrant must file your medical device registration application with the HSA and act as the liaison between your company and the regulatory authorities. The Registrant also owns your HSA registration and controls the listing of authorized importers in Singapore. Only companies or individuals based in Singapore can act as a Registrant; they must also be registered with the HSA.
Emergo is a full-service regulatory consulting firm with an office in Singapore
Emergo has the experience and resources to help you succeed in Singapore. We understand the importance of independent representation and our experts in Singapore have the regulatory expertise to serve the interests of your company. As your Registrant, we can:
- Submit your registration application and dossier to the HSA
- Respond to inquiries from the HSA on your behalf
- Cooperate with you to ensure you maintain control of your HSA registration
- Assists with post-market surveillance and vigilance activities and assist with adverse-event reporting, if needed
Emergo acts as an in-country representative to more than 2,000 medical device manufacturers in markets around the world.
Is a Registrant required for all device classifications?
No. Foreign manufacturers are not required to appoint a Registrant if they are selling Class A device.
What is the difference between a Registrant and a Licensed Importer?
The Registrant is your liaison with the HSA and controls your device registration listing. The Licensed Importer, on the other hand, performs the business and administrative functions of importation. However, the Registrant and Importer can be one and the same.