Regulations on Import & Supply

1. Medical/Dental Devices

Import via licensed importers

Singapore allows only licensed importers to import medical devices into the country. Medical devices that have not been assessed by the Health Sciences Authority (HSA) Medical Device Branch (MDB) and have not been registered in Singapore for sales & distribution can only be brought into Singapore through HSA Authorization Route (GN-29 for exhibition purpose).

Conditions are the following:

  • No sales of the display products during exhibition, especially to local companies. Should exhibitor decides sell to an overseas buyer, Schenker Singapore will have to perform the re-exportation for documentation purposes.
  • All products are required to be re-exported out of Singapore post event.
  • A fee will be imposed for every application.
  • The application is subject to HSA (MDB)'s approval.
  • The application process takes up to 14 working days.
  • The approval has to be obtained before the exportation of the goods from the origin country.

Class A Medical Devices (non-sterile) are exempted from product registration. Exhibitors are encouraged to refer to the guide GN-22 in order to understand which of their products may be exempted from registration. It is also the exhibitor's responsibility to identify their products correctly & truthfully.

As per HSA requirements, all unregistered medical/dental devices or products imported for the exhibition must be labeled "For display purpose only. Not intended for supply".

For all importation of goods into Singapore for the exhibition, HS codes (Harmonized Commodity Description and Coding System) are required to determine if a medical device requires registration or is exempted. It is the duty & responsibility of the exhibitors to provide the correct HS codes to the freight forwarder in their customs declarations. Should the exhibitor identify their products as exempted from the registration (check against GN-22), we recommend the exhibitors to use the HS codes in the guide for easier customs clearance.

Import via hand-carry by exhibitors

For hand-carry items, the exhibitor will be required to obtain approval from HSA before they enter Singapore with their items. They will be required to fill up the  application form and email to HSA together with a copy of the commercial invoice for the items they intend to hand-carry into Singapore for the event. Once approved, HSA will send the authorization letter back to the exhibitor and he/she will be required to bring along the document when entering into Singapore. They have to present the documents to the Customs Officers in the Airport Customs Checkpoint during clearance.

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

The above content is extracted from the HSA Medical Device Branch and is valid as of May 2015. 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. labeling, 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. Health Science Authority website
  2. Guidelines for Importation of Medical Devices for Exhibitions in Singapore
  3. Control of Cosmetic Products
  4. Change Notification for Registered Medical Devices
  5. Guidance for Dealers on Class A Medical Devices Exempted from Product Registration
  6. Guidance on Requirements for Exemption from Product Registration to Supply Imported or Manufactured Unregistered Medical Devices for Non-Clinical Purpose
  7. Request Form for "Letter of No Objection for Exhibition"