Import and Supply Regulations
It is imperative that for participating exhibitors/attendees ensure their product compliance to the Import and Supply Regulations under the Health Products Act by Health Sciences Authority (HSA).
Regulatory Control for Medical Devices in Singapore
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.
Authorisation for Import of Unregistered Medical Devices for Exhibitions
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.
Handling of medical devices during the exhibition
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.
Post‐Exhibition handling of medical devices
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.
Exhibitors can confirm if their product is a medical device with the Product Classification Tool. The outcome of this tool corresponds to the answers given during the online assessment by the user.
It is also the responsibility of the exhibitors to ensure that the product meets the requirements of any other applicable regulatory controls in Singapore.
For more information on import of unregistered medical devices for exhibition, you may wish to refer to HSA website.
If exhibitors are intending to bring in Monkeypox and/or SARS-CoV-2 kits, please note on the following restrictions to the number of pieces you are allowed to bring into Singapore:
• Self-test kits – maximum 10 pieces
• Other tests e.g. Professional use test kits/assays, laboratory use reagents - maximum 2 pieces
For further queries on the process and regulatory requirements for importation of unregistered medical devices for exhibition in Singapore via GN-32, please contact:
Medical Devices Cluster
Health Sciences Authority
Email: hsa_md_info@hsa.gov.sg
Phone: (65) 6866 1111
Fax: (65) 6478 9028
HSA Circular to Exhibitors & Importers
HSA Circular to Exhibitors Onsite
Form 32: Application for Importation of Unregistered Medical Devices for Exhibition
Lines Exhibition Pte Ltd
In Affiliation : Lines Exposition & Management Services Pte Ltd
701 Geylang Road #03-01 Teambuild Centre Singapore 389687
Tel : (65) 6299-8611 Fax : (65) 6299-8633
Email : enquiry@lines.com.sg
Website : www.beautyasia.com.sg
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