Singapore: Guidance For Importation Of Unregistered Medical Devices For Exhibition In Singapore
On 29 June 2022, Health Sciences Authority (HSA) Singapore published an update to guidance document, GN-32 GUIDANCE FOR IMPORTATION OF UNREGISTERED MEDICAL DEVICES FOR EXHIBITION IN SINGAPORE Revision 4. Regardless of risk class, unregistered medical devices (human use) for exhibition, are subjected to regulatory controls under the Singapore’s law.
Applicants are required to obtain an approval from HSA prior to importation of the unregistered medical devices for exhibition purposes. For local companies exhibiting locally-manufactured medical devices, this approval is not required to be obtain prior to displaying their products at the exhibition.
Available product importation routes are either as cargo goods carried out by a Singapore registered company on behalf of the exhibitor or via hand-carry by the exhibitor. The approval permits will be issued to the importer, whether it is a Singapore registered company or the exhibitor.
The applicant (either importer / exhibitor) shall submit the following documents to the HSA:
- Accomplished FORM 32-A (Annex 1 of GN-32 Revision 4);
- Information of the event such as brochures, website, and / or passport page with personal particulars of importer for goods imported via hand-carry;
The application shall be submitted via email address at firstname.lastname@example.org. The turnaround time for approval is approximately 10 working days.
Labels or signages bearing “SOLELY FOR DISPLAY PURPOSES ONLY. NOT INTENDED FOR SUPPLY” on the unregistered medical devices shall be displayed prominently during the exhibition. Applicants are also reminded to verify other obligations with relevant controlling agencies. For full details, please refer to the attachment.
After the exhibition, all importers and exhibitors shall ensure that the unregistered medical devices are exported out of Singapore or destroyed, according to the stipulated licensing conditions in the importer’s license.
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