Apply for a medical device dealer's licence
You need to use SHARE to apply for a dealer's licence. This includes the manufacturer, importer and wholesaler's licences.
Last updated 5 June 2026
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.
Import, supply and manufacture of drug of abuse test kits needs additional controlled drug licences under the Misuse of Drugs Act besides licences under Health Products (Medical Devices) Regulations. For more information, please refer to HSA | Apply for a controlled drugs licence
Documents required
You will need to upload supporting documents depending on the type of licence.
Importer's licence
Submit one of the following documents on your Quality Management System (QMS):
MDSAP certificate and audit report
ISO 13485 certificate and audit report
The scope must include distribution of the categories of medical devices and the activities performed at the facility, where applicable
This certificate needs to be issued by a certification body accredited by the Singapore Accreditation Council (SAC).
GDPMDS certificate and audit report
This certificate needs to be issued by a certification body accredited by the Singapore Accreditation Council (SAC).
Declaration for dealing with medical devices that are solely for export or re-export purposes.
Declaration of Conformity to a QMS (for company dealing with Class A medical devices only).
Guide to new application for medical device dealer's licence.
Wholesaler's licence
Submit one of the following documents on your Quality Management System (QMS):
MDSAP certificate and audit report
ISO 13485 certificate and audit report
The scope must include distribution of the categories of medical devices and the activities performed at the facility, where applicable
This certificate needs to be issued by a certification body accredited by the Singapore Accreditation Council (SAC).
GDPMDS certificate and audit report
This certificate needs to be issued by a certification body accredited by the Singapore Accreditation Council (SAC).
Declaration for dealing with medical devices that are solely for export or re-export purposes.
Declaration of Conformity to a QMS (for company dealing with Class A medical devices only).
Guide to new application for medical device dealer's licence.
Manufacturer's licence
Submit one of the following documents on your Quality Management System (QMS):
MDSAP certificate and audit report
ISO 13485 certificate and audit report
This certificate needs to be issued by a certification body accredited by the Singapore Accreditation Council (SAC).
Declaration of Conformity to ISO13485 (for company dealing with Class A medical devices only).
Guide to new application for medical device dealer's licence.
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 SHARE.
Withdraw a licence application
You may choose to withdraw an application while in progress, via SHARE.