Local authorised representative in Singapore
The Health Sciences Authority (HSA) or medical device authority in Singapore require foreign manufacturers who have not set up their own legal subsidiary to appoint a Local Authorised Representative (LAR), sometimes referred to as the in-country representative, local marketing authorization holder or Registrant.
Andaman Medical has been a Registrant in Singapore since 2017.
What are the requirements for a marketing authorization holder or LAR in Singapore?
- A local authorized representative must have a Client Registration and Identification Service (CRIS) company account from the Health Sciences Authority (HSA) and a dealer license according to their activity: Manufacturer’s License, Registrant's License, Importer’s License or Wholesaler’s License (import and export). Only Singaporean companies can apply for a Registrant Account.
- A Letter of Authorization (in the prescribed format) for the Registrant needs to be provided by the foreign manufacturer for all products and models of the devices which are to be registered. The Letter of Authorization must be issued on the Product Owner’s Letterhead with a physical signature and stamp (no scanned signatures are allowed).
Can you appoint multiple marketing authorization holder or LARs?
- Yes, multiple Registrants are allowed in Singapore but please note that ALL registrants must register the device individually. Every time you register the device it will be evaluated as a new device application and therefore the registration fees are applicable each time.
- Registrants can be changed by applying for a Change of Registrant which has a turnaround time of 40 working days and a HSA fee of S$820 per application.
How Andaman Medical can help with in-country representation in Singapore:
As your marketing authorization holder or local authorized representative in Singapore we will:
- represent your company in all dealings with the Health Sciences Authority responsible for medical devices and in-vitro diagnostics including:
- registering your product
- submitting change notifications
- transferring product licences
- ensuring post-market surveillance once your product is authorized and placed in the market, including reporting Adverse Events and Field Safety Corrective Actions
- Add your selected Importers and/or Wholesalers for the devices to the MEDICS online portal
- Ensure that the appropriate conformity assessment procedure has been carried out, if required
- Accept all calls from the HSA regarding the foreign manufacturer and its products and liaising accordingly with the foreign manufacturer including scheduling inspection(s) of the manufacturer’s facilities, if required
- Maintain our office including a telephone and email connection in Singapore
- Assist with complaint handling
- Monitor regulations to alert you to any changes or new regulations applicable to your product.