New Medical Device Clinical Trial Regulations in Singapore

As part of an effort to simplify its requirements for clinical trials, Singapore is streamlining its regulations for imported medical device products used in clinical trials. These new regulations were announced in July 2016 and will go into force November 1, 2016. Two key changes include: (1) clinical trial materials (CTM) will now be described as clinical research materials (CRM) and (2) a notification system for CRMs will replace the requirement of an import license for any clinical trial that uses imported CRMs. This change should make the process of importing medical devices for device clinical trials easier.