Medical device distribution in Singapore
Only registered medical devices may be distributed in Singapore, which means that the product is listed on the Singapore Medical Device Register (SMDR), unless exempted from registration (all Class A products).
Who can distribute medical devices in Singapore?
What are the requirements for distributing medical devices in Singapore?
Advertising, communication and promotion of medical devices is a common part of a distribution contract, either falling to the manufacturer or the local distributor to undertake. Please note, that in Singapore, advertisements of medical devices do not require prior approval by the HSA unless they fall under the definition of ‘’label’’ as set out in the Health Products Act. Moreover, you have to ensure that the advertisements comply with the requirements stated in the Health Products Act and the Regulations. Guidance on adverts and sales promotion exists in guidance document GN-08.
Distributor’s duties and obligations
It is mandatory for wholesalers (distributors) of medical devices and IVDs to Singapore to:
How Andaman Medical can help with distributing medical devices in Singapore:
Acting as your independent local authorized representative or marketing authorization holder in Singapore, we will register and maintain your device license which also means you can appoint as many wholesalers for your device as you require while the product license is not affected by any changes in your distributor network. We will work with your chosen distributors to: