Import of unregistered medical devices for exhibition

Overview

An approval is required prior to the import of unregistered medical devices into Singapore for exhibitions. These devices are permitted only for display purposes at exhibitions and are not allowed to be:

• Used on humans, including for demonstration purposes.

• Supplied locally for any other purposes, including being distributed as free samples.

These products must be exported out of Singapore or destroyed after the exhibition within the timeframe stipulated in the approval by us.

Note: Prototype replicas meant to show only the physical dimensions of the actual medical device do not require approval.

Import methods

Import as cargo goods

The application for the import of unregistered medical devices as cargo goods must be submitted by a Singapore registered company to us for approval

This approval allows the import of multiple consignments of unregistered medical devices for the specified event, and is valid for the period from the date of issuance to expiry.

Import via hand-carry

This approval allows exhibitors to hand-carry limited quantities of unregistered medical devices on an individual basis.

Additional requirements from other regulatory agencies

As the importation of any goods into Singapore is also regulated by the Singapore Customs, please refer to their website for more information.

There is no restriction for activating the devices at exhibitions provided it does not pose any safety issues to the public. However, the National Environmental Agency (NEA) has prohibited the energising or switching on of medical devices which can emit radiation such as X-ray equipment and lasers in the public, unless the appropriate radiation licences have been obtained from NEA.

Application processing time

The processing time for the approval to import may take up to 10 working days upon submission of a complete application. Please submit your applications early so that the approval for the importation can be issued in time for the exhibition.

How to apply

You will need to submit Form 32 online..

The table below details all the documents/information you need for the application submission online.