Questions About Singapore? We can help.

We have completed 150+ Singapore consulting projects.

Singapore Local Representation for Medical Device Companies


  • 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. However, the Registrant has more significant responsibilities as well. The registrant also owns your HSA registration and controls the listing of authorized importers in Singapore.

Licensing requirements for Singapore Registrant

Your Singapore Registrant must be a company based in Singapore and registered with the HSA. Emergo maintains offices in Singapore, and can act on your behalf as your Singapore Registrant as well as your Licensed Importer.

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
  • Act as your Licensed Importer of Record

Emergo acts as an in-country representative to more than 2000 medical device manufacturers in markets around the world.

Ask us for detailed information about Singapore Local Representation services.

Learn about the process, costs and timelines.

Request More Information
{{ phone }}
See list of all offices

Common Questions

Is a Registrant required for all device classifications?
No. Foreign manufacturers are not required to appoint a Registrant if they are selling Class A non-sterile device in Singapore.

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. Learn more about Licensed Importer role and responsibilities.