Regulatory Authority
Health Sciences Authority (HSA)
Classification
A, B, C, D
Quality system
ISO 13485:2016
The information on this page is valid and current as of January 2017. The legislative and regulatory provisions are subject to changes and updates by the Regulatory Authorities of the State to which they refer. Considering the above, the writer declines all responsibility regarding any non-actuality and/or inaccuracy of the information received concurrently with or following the publication of this page Disclaimer
Medical Device Registration in Singapore
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.
Applicant
Local Authorized Representative.
Timeframe and fees
Timeframe: 1-8 months.
Costs: 25,00$ – 5.700,00$
Validity
Unlimited.
Labelling and documentation language
Documentation and labelling must be provided in English.
