Regulatory Authority

Health Sciences Authority (HSA)


Classification

A, B, C, D


Quality system

ISO 13485


Procedure

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 USD – 5.700,00 USD


Validity

Unlimited validity.


Labeling and documentation language

Documentation and labeling must be provided in English.