REGULATORY UPDATE | HSA released the guidance document GN-32-Rev5: Guidance for Importation of Unregistered Medical Devices for Exhibition in Singapore.

on August 30, 2022. The Ministry of Health issued an application letter to invite company leaders to update the 2022 Indonesian Medical Devices Catalog Book Data. The Ministry of Health, through the Directorate of Production and Distribution of Medical Devices, and the Directorate General of Pharmaceuticals and Medical Devices made or compiled an updated Indonesian Medical Devices Catalog Book in an effort to increase the use of domestic products, including domestic medical devices, as well as to support the development of the domestic medical device industry.

Under Singapore law, it is illegal to import and distribute unregistered medical devices. products that, as required by law, are clearly labeled by the manufacturer as not for use on people. Exhibitors can use the product classification tool on The official Health Sciences Authority (HSA) website. website resmi

This revision applies to all medical equipment applications adopted for the Singapore Exhibition, regardless of classification. Local businesses displaying locally made medical equipment do not need to obtain a permit to display their wares at trade shows. the fact that medical devices cannot be used on people or are only available for use locally, but must be clearly stated on a label or sign clearly displayed by the manufacturer.

To import unregistered medical equipment used for display, the applicant must fill out FORM 32 online

Read full information at the original source Health Sciences Authority

Contact us if you want to inquire about registration of medical devices. Contact Us