Find out more about what is required for clinical trials of medical devices.
Medical device clinical trials are not regulated by us -- they are required to comply with the requirements of the Human Biomedical Research Act.
In addition, the manufacture, import and supply of medical devices used as a clinical research material (CRM) in Singapore must comply with the regulatory controls for clinical research materials.
Regulatory overview
Register your device
Changes to registered devices
Dealer's licence
Free Sales Certificate and Export Certificate
Report adverse events
Field Safety Corrective Action reporting
Clinical trials
Consultation schemes
Advertisements and promotions
Bringing personal medical devices into Singapore
Guidance documents
Fees and turnaround time
COVID-19: Standards Resources for Essential Medical Devices
Digital Health
International collaboration
Standards for Medical Devices
Registration and licensing tools
MEDICS
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