Recognized standards are often used to demonstrate conformity to the Essential Principles of Safety and Performance of Medical Devices. On September 05, 2023, the Health Sciences Authority (HSA) of Singapore published a list of recognized standards for medical devices. This list matches the nationally recognized Singapore Standards (SS) against that of other Standard Development Organizations such as ISO, IEC, and ASTM.
The list also consists of 4 notable Singapore Standards (SS) that are not referenced to ISO, IEC nor ASTM, namely:
- In-Vitro Diagnostics – SS 656:2020 Design, development, and validation of miRNA-based diagnostics
- Quality Management System – SS 620:2013 (2021) Good distribution practice for medical devices – Requirements
- Thermal Imagers:
- SS 582:2020 Specification for thermal imagers for human temperature screening – Part 1 : Requirements and test methods
- SS 582:2020 Specification for thermal imagers for human temperature screening – Part 2 : Implementation guidelines.
For more details, please refer to the Standards for Medical Devices that can be accessed here.
Should you have any inquiries or require further assistance, please do not hesitate to contact us at sales@andamanmed.com or click the button below.