Regulations on Import & Supply

1. Medical/Dental Devices

Legal 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 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 non-sterile 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.

All applications are also subject to:

  • A processing fee
  • Process up to 14 working days upon submission of complete application
  • Approval by HSA (Medical Device Branch)
Approval has to be obtained before the exportation of goods from origin country.
 
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.
 

Import via licensed importers

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 32A
  • 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.

 

Import via hand-carry by exhibitors

Limited quantities of unregistered medical devices to be used for exhibitions may be imported via hand-carry by an overseas exhibitor on an individual basis. It is the exhibitor’s responsibility to ensure that the importation is in compliance with the relevant authorities such as the Singapore Customs regulations and any other aviation or shipping requirements.

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

  • FORM 32A
  • Information of event (Name, Period and Venue)
  • Passport Page with Personal Particulars of Importer

 

Local companies exhibiting their medical devices

Local companies exhibiting locally manufactured medical devices are not required to obtain any authorization 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 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. 

More detailed information can be obtained through HSA Medical Devices Overview Page.

The above content is extracted from the HSA Medical Device Branch and is valid as of 2016. It is subjected to change without prior notice. We strongly encourage all users to also visit the Health Sciences Authorities website for the most up to date information.

 

2. Cosmetic Products

No particular approval is required from HSA Cosmetic Control Unit (CCU) for exhibition purposes, including distribution as samples for advertising or promotional activities. However, please note that compliance with the other ASEAN Cosmetic Directive (ACD) requirements is necessary e.g. labelling, the safety of ingredients and adverse event reporting.

For more detailed information please visit the HSA Cosmetic Products Overview Page.

It is the exhibitor's responsibility to ensure their products complies with the ACD requirements should they be distributing their products as samples during the event.

Any changes in the existing laws and regulations may render the content invalid. we strongly encourage all users to also visit the Health Sciences Authorities website for the most up to date information.

 

3. Further useful information:

  1. Frequently Asked Questions
  2. Health Science Authority website
  3. Guidelines for Importation of Medical Devices for Exhibitions in Singapore
  4. Control of Cosmetic Products
  5. Change Notification for Registered Medical Devices​
  6. ​Guidance for Dealers on Class A Medical Devices Exempted from Product Registration​