Regulatory Authority

Health Sciences Authority (HSA)


A, B, C, D

Quality system

ISO 13485:2016

Medical Devices are subject to registration.

Manufacturers without local presence in Singapore must appoint a Local Authorized Representative responsible for submitting the documents required in the registration process to the HSA.
Non-sterile Class A Medical Devices are exempt from registration, but an application is required as established by ASEAN. Devices already registered in other countries (European Union, Japan, USA, Canada, Australia) may be eligible for an immediate registration procedure.


Local Authorized Representative.

Timeframe and fees

Timeframe: 1-8 months.
Costs: 25,00$ – 5.700,00$



Labelling and documentation language

Documentation and labelling must be provided in English.

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