Apply for a medical device dealer's licence

You need to use MEDICS to apply for a dealer's licence. This includes the manufacturer, importer and wholesaler's licences.

Types of licences

Importer's licence

An importer's licence allows the dealer to bring a medical device into Singapore.

Licensed importers require a Wholesaler's licence for wholesale supply.

Wholesaler's licence

A wholesaler's licence allows the dealer to:

  • supply a medical device by wholesale (including export) in Singapore.
  • supply a medical device to a party for re-supply.
  • supply a medical device as a commercial sample.

However, a wholesaler's licence is not required for supply to end-users, such as in a retail store.

Manufacturer's licence

A manufacturer's licence allows the dealer to:

  • Make, fabricate, produce or process a medical device.
  • Package and label a medical device before it is supplied.

Licensed manufacturers do not require a Wholesaler's licence to supply medical devices which are manufactured under their Manufacturer's licence.

Documents required

You will need to upload supporting documents depending on the type of licence.

  1. Submit one of the following documents on your Quality Management System (QMS):
  2. Guide to new application for medical device dealer's licence583 KB.

  1. Submit one of the following documents on your Quality Management System (QMS):
  2. Guide to new application for medical device dealer's licence512 KB.

Fees and turn-around-time

Refer to medical device fees and turn-around-time for more information.

How to apply

You can apply for a dealer's licence using MEDICS.

Don't have a MEDICS account? Apply now through CRIS.

Withdraw a licence application

You may choose to withdraw an application while in progress, via MEDICS.

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