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.

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.

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.

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.

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.

Last updated: 31 Dec 2018