HSA Circular to Exhibitors and Importers
1. Regulatory Control for Medical Devices in Singapore
In Singapore, medical devices are subject to regulation under the Health Products Act. Under this law, theimport and supply of all medical devices, including in vitro diagnostic devices (IVD), are required to belicensed and registered, respectively, by HSA before any of such activities can be legally carried out, unlessotherwise 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 MedicalDevice Register (SMDR).
For the importation of unregistered medical devices for exhibition purposes, the importing party shallseek approval via GN32 from HSA prior to importing the specific consignment. Details for GN32 is
published in www.hsa.gov.sg
The Health Sciences Authority would like to remind all that any unregistered medical device which ispermitted 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 exported out of Singapore or destroyed after the exhibition.
The supply of an unregistered medical device is an offence under Singapore’s law and is liable onconviction to a fine not exceeding $50,000 or to a jail term not exceeding 2 years or to both.

2. 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
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-A
• Information of event (Name, Period and Venue)
An approval for importation of unregistered medical devices for exhibition purposes will be issued to theSingapore registered company. 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 ofexpiry.

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Import via Hand‐Carry by Exhibitor
All applications for importation of unregistered medical devices for exhibition via hand-carry shall besupported with the following details such as:• FORM 32-A
• Information about the exhibition (Name, Period and Venue)• Passport Page with Personal Particulars of Importer
When will you receive the approval?
Please submit your application early so that the approval for the importation can be issued in time for theexhibition. A processing time of up to 10 working days is required upon submission of a complete
application.
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.

3. 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 theregulatory and legal controls for medical devices in Singapore.

4. Post‐Exhibition handling of medical devices
After the exhibition, all importers and exhibitors must ensure that these unregistered medical devices areexported out of Singapore or destroyed according to the stipulated licensing conditions in the importer’slicence.
For further queries on the process and regulatory requirements for importation of unregistered medicaldevices 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

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Frequently Asked Questions
1. How do I tell if my product a medical device?
Medical devices contains a wide array of products, ranging from contact lenses, surgical tools, walkingsticks, wheelchairs, through life maintaining implantable devices, equipment to screen and diagnosediseases and health conditions (e.g. pregnancy test kit), to the most sophisticated diagnostic imaging
and minimal invasive surgery equipment.
Definition of a medical device, as found in the First Schedule of the Health Products Act(https://sso.agc.gov.sg):“Medical device” —(a) means any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use,
software, material or other similar or related article that is intended by its manufacturer to be used,
whether alone or in combination, for humans for one or more of the specific purposes of —(i) diagnosis, prevention, monitoring, treatment or alleviation of any disease;(ii) diagnosis, monitoring, treatment or alleviation of, or compensation for, an injury;(iii) investigation, replacement, modification or support of the anatomy or of a physiological process,mainly for medical purposes;(iv) supporting or sustaining life;(v) control of conception;(vi) disinfection of medical devices; or(vii) providing information by means of in vitro examination of specimens derived from the human body,for medical or diagnostic purposes, and which does not achieve its primary intended action in or on thehuman body by pharmacological, immunological or metabolic means, but which may be assisted in its
intended function by such means; and(b) includes the following articles:(i) any implant for the modification or fixation of any body part;(ii) any injectable dermal filler or mucous membrane filler;(iii) any instrument, apparatus, implement, machine or appliance intended to be used for the removal ordegradation of fat by invasive means.
It is the responsibility of the exhibitor to determine if their product is a medical device in accordance withlocal regulations prior to import.

2. How do I determine if my product is a medical device and its associated risk classification inSingapore?
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.

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3. I am importing models*/demo units for exhibition. Do I need to apply for GN32?
* Replicas of actual device
Products that are clearly intended by their manufacturer not to be for human use are not medical devices
under the definition above. Such products will not be subject to medical device regulatory controls inSingapore.
Please be reminded that it is the responsibility of the exhibitors and applicants to ensure that theproduct meets the requirements of any other applicable regulatory controls in Singapore.

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