Medical device importation to Singapore
Only registered medical devices may be imported into Singapore, which means that the product is listed on the Singapore Medical Device Register (SMDR) unless exempted from registration (all Class A products). Any company wishing to import medical devices and in-vitro diagnostics (IVDs) into Singapore must have a valid Importer’s License from the Health Sciences Authority.
What are the requirements for importing medical devices into Singapore?
Are there any exemptions?
Special Access Routes for importing medical devices into Singapore
Importers duties and obligations
It is mandatory for importers of medical devices and IVDs to Singapore to:
How Andaman Medical can help with importing medical devices to Singapore:
Acting as your independent local authorized representative or marketing authorization holder in Singapore means you retain the freedom to appoint as many importers or wholesalers for your device as you require, while your product license remains unaffected by any changes in your distributor network. We will work with your appointed importers and/or wholesalers to: