Medical Device Registration and Approval in Singapore
General country-specific regulatory information is provided on this page for medical device registration and approval in Singapore. Become a LICENSALE.COM user to receive detailed device-specific compliance information for each market, including Singapore, to expedite the preparation of your medical device or IVD registration application.
Medical Device Regulations and Classification in Singapore
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.
For more information on Medical Device Registration in Singapore, check out the following articles on our blog!
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