Health Sciences Authority (HSA)
A, B, C, D
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 USD – 5.700,00 USD
Labeling and documentation language
Documentation and labeling must be provided in English.