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Health Sciences Authority

Importer, wholesaler and manufacturers' licensing

You need a dealer's licence if you manufacture, import or wholesale medical devices in Singapore.

Last updated 13 March 2026

Amend a medical device dealer's licence

You must notify us of changes to your dealer's licence on details such as medical device risk classification, QMS certification and site details.

Apply for a medical device dealer's licence

You need to use SHARE to apply for a dealer's licence. This includes the manufacturer, importer and wholesaler's licences.

Quality Management System (QMS) for Medical Devices

To ensure the safety, quality, and performance of medical devices, companies involved in manufacturing, importing, or distributing medical devices in Singapore must establish and maintain an appropriate Quality Management System (QMS) in accordance with regulatory requirements.

Renew or cancel a medical device dealer's licence

Renew your dealer's licence on time to continue dealing in medical devices in Singapore.