Clinical trials of medical devices

Find out more about what is required for 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

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.

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

Last updated: 31 Dec 2018

Clinical trials of medical devices

Medical Device Clinical Research Examples

Medical devices

Medical devices