HSA has included “ISO 13485:2016” in defining the projected useful life of a medical device.
Product owners may refer to ISO 13485:2016 – Medical devices – A practical guide, for some of the considerations when defining the lifetime of their medical device.
For more details, refer to updated guidance GN-06 at the following link: https://www.hsa.gov.sg/docs/default-source/hprg-mdb/guidance-documents-for-medical-devices/gn-06-r3-guidance-on-distribution-records(2022-nov)_pub.pdf