Singapore
General country-specific regulatory information is provided on this page. Become a LICENSALE.COM user to receive detailed device-specific compliance information for each market, free of charge, to expedite the preparation of your medical device or IVD registration application.

REGULATORY AUTHORITY
: In Singapore, medical devices are regulated by the Health Sciences Authority (HSA).

CLASSIFICATION SYSTEM: Medical devices in Singapore are divided into four classes: A, B, C and D.

TIMEFRAME: The length of the registration process depends on the class of the device and ranges from 30 to 365 working days.

LICENSE VALIDITY: Licenses issued in Singapore must be renewed on a yearly basis.

AUTHORIZED REPRESENTATIVE: A local authorized representative is required.

Last updated on February 22, 2017.



Interested in obtaining fast market approval for your medical device or IVD in Singapore? REQUEST A FREE QUOTE>

For more information on registration in Singapore, check out the following articles on our blog:
Country at a Glance: Singapore
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