Clinical trials of medical devices

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.

The duties and obligations of local manufacturers, importers and suppliers (including local sponsors and investigators) of medical devices used as CRM include the following:

Submit a CRM notification Understand the application process and required documents for your Clinical Research Material notification. Report adverse events Understand the requirements for safety reporting in clinical trials.