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:

• 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