In Singapore, medical devices are subject to regulation under the Health Products Act. Under this law, the import and supply of all medical devices, including in vitro diagnostic devices (IVD), are required to be licensed and registered, respectively, by HSA before any of such activities can be legally carried out, unless otherwise exempted under the provisions of the law. Currently, only Class A medical devices do not require product registration in Singapore. Whereas, registered medical devices are listed in the Singapore Medical Device Register (SMDR).

For the importation of unregistered medical devices for exhibition purposes, the importing party shall seek approval via GN32 from HSA prior to importing the specific consignment. Details for GN32 is published in www.hsa.gov.sg.

Health Sciences Authority would like to remind all that any unregistered medical device which is permitted for display at the exhibition:

• Shall not be supplied for use locally, which includes distribution of free samples or the use of such medical devices on a human for demonstration purpose, and

• Shall be destroyed or exported out of Singapore after the exhibition.

The supply of an unregistered medical device is an offence under Singapore’s law and is liable on conviction to a fine not exceeding $50,000 or to a jail term not exceeding 2 years or to both.

There are two options for importation of unregistered medical devices for exhibition purposes:

1. Import as cargo goods

2. Import via hand-carry by exhibitor

1. Import as Cargo Goods

All importation of unregistered medical devices for exhibition should be carried out by a Singapore registered entity. An application shall be submitted with the following:

• FORM 32: Application for Importation of Unregistered Medical Devices for Exhibition

• Information of event (Name, Period and Venue)

An approval for importation of unregistered medical devices for exhibition purposes will be issued to the Singapore registered entity. The approval permits 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 date of expiry.

2. Import via Hand‐Carry by Exhibitor

All applications for importation of unregistered medical devices for exhibition via hand-carry shall be supported with the following details such as:

• FORM 32: Application for Importation of Unregistered Medical Devices for Exhibition

• Information of event (Name, Period and Venue)

• Passport Page with Personal Particulars of Importer

2.3. When will you receive the approval?

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

2.3. Local companies exhibiting their medical devices

Local companies exhibiting locally manufactured medical devices are not required to obtain any authorisation for displaying their products at the exhibition. However, local exhibitors are reminded that supply of unregistered medical devices at the exhibition is prohibited under the law.

Exhibitors of unregistered medical devices are required to prominently indicate that the medical devices exhibited cannot be legally supplied locally.

This shall be done in the following ways:

• Have prominent labels or signs at their display booths, with a statement to the effect of “Solely for display purposes only. Not intended for supply.”

• Unregistered, medical devices are to bear a label with a statement to the effect of “Solely for display purposes only. Not intended for supply.”

HSA officers may be present during the exhibition to perform random checks for compliance with the regulatory and legal controls for medical devices in Singapore.

After the exhibition, all importers and exhibitors must ensure that these unregistered medical devices are destroyed or exported out of Singapore according to the stipulated licensing conditions in the importer’s licence.