Clinical trials of medical devices

Medical device clinical trials 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:

• Ensure the medical device complies with the safety and performance requirements set out by HSA

• Maintain proper record keeping, labelling and disposal

• Report medical device defects and adverse effects to HSA

• Report CRM non-compliances to HSA

• Notify HSA on product recall and field safety corrective actions

Medical Device Clinical Research Examples

The following is an example of a clinical trial that has been conducted within local healthcare institutions. This list is not exhaustive and does not constitute an endorsement of any particular device, treatment, or company.

• Medical device name: Viva Konnect Clinic Portal and Patient App

• Trial title: Feasibility study of a smartphone-based patient application and web-based clinic portal platform for remote patient monitoring of chronic kidney disease and peritoneal dialysis patients

• Objective: Acceptance of the application by patients/caregivers

• Study phase/type: Phase I / Feasibility Study

Useful links

• Submit a CRM notification

• Report adverse events