REGULATORY UPDATE | Guidance on Importation of Unregistered Medical Devices for Exhibition in Singapore

On August 30, 2022, the Health Sciences Authority (HSA) released the guidance document GN-32-Rev5, which outlines the regulations regarding the importation of unregistered medical devices for exhibition purposes in Singapore. Concurrently, the Indonesian Ministry of Health issued an application letter inviting company leaders to update the 2022 Indonesian Medical Devices Catalog Book Data. This initiative, led by the Directorate of Production and Distribution of Medical Devices and the Directorate General of Pharmaceuticals and Medical Devices, aims to promote the use of domestic products, including medical devices, and to support the growth of the domestic medical device industry.

Under Singapore law, it is illegal to import and distribute unregistered medical devices. Products must be clearly labeled by the manufacturer as "not for use on people" if they do not meet the registration requirements. Exhibitors can utilize the product classification tool available on the official HSA website for. further guidance.

This revised guidance applies to all medical equipment applications for the Singapore Exhibition, regardless of their classification. Local businesses displaying locally manufactured medical equipment are exempt from obtaining a permit to showcase their products at trade shows, provided that the devices cannot be used on people or are only available for local use. This must be clearly indicated on a label or sign prominently displayed by the manufacturer.

To import unregistered medical equipment for display, applicants must complete FORM 32 online.

For full information, please refer to the original source at the Health Sciences Authority.

For inquiries regarding the registration of medical devices.