Singapore’s Health Sciences Authority (HSA) updated the Medical Device Adverse Event Reporting Form for Medical Device Dealers (MDAR1 Form). As a management committee member of the International Medical Device Regulators Forum (IMDRF), HSA is committed to adopting globally harmonized approach to the application of unique device identifiers (UDI) and the use of the IMDRF adverse event terminologies.
In line with this, the following fields have been included in the MDAR1 form:
• Unique Device Identifier
• IMDRF Adverse Event Reporting Terms and Codes
These new fields are non-mandatory. However, HSA strongly encourages stakeholders to input this information, where available, to facilitate better traceability and support data analysis of medical device safety issues.
The updated form can be accessed at HSA’s website: https://www.hsa.gov.sg/medical-devices/adverse-events