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!

Other Southeast Asian Countries:

Cambodia, Indonesia, Malaysia, Myanmar, PhilippinesThailand, Vietnam

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