Importing Medical Devices into Singapore

Product Owner (brand owner) needs to have a local authorised representative (a locally registered business entity) to register its product with the Health Sciences Authority of Singapore (H.S.A.)before the device can be imported into Singapore. Unregistered medical device can be imported but need special authorisation from the H.S.A. irrespective of the import purpose (e.g.exhibition, demonstration, clinical or non-clinical use).

Medical Device can only be registered under the name of a locally registered entity. If the foreign Product Owner has a locally registered entiry in Singapore, it may register its products under this entity. If not the Product Owner needs to appoint a local authorised representative to register its products. Product Owners can appoint an independent company like Cubicpharma to act as their authorised representative to register their products and appoint other companies to import and distribute their products. If the product is registered with a distributor, when there is a need to change distributor the product will again need to be re-registered, incurring additional cost and risk of interruption to supply.

In Singapore medical devices are split into 2 device types a) General Medical Devices and b) In-vitro Diagnostics Medical Devices. These 2 devices types are split into 5 Risk Classes:

  • Lower Risk Classes: Class A Exempt, Class A Sterile, Class B
  • Higher Risk Classes: Class C and Class D (D being the highest)

Devices already registered with one of the regerence agency from US, EU, Canada, Australia or Japan can enjoy quicker registration duration by going the Abridged Evaluation route. There are also expedited routes if the device is registered in 2 or more of the above countries' regulatory authority. Class B and C device with 1 reference agency for more than 3 years also qualifies for expedited evaluation route. Class D device with 2 or more reference agencies also qualifies for expedited evaluation route.

Regulatory Affairs Services

Product Registration

  • Medical Devices
  • Pharmaceuticals

 

In-country Representation

  • Singapore
  • Malaysia
  • Other Countries

 

Establishment Licences

  • Importer
  • Wholesaler/Distributor