There were 3 revisions that HSA included in the latest GN-10 document. Refer to Table 1 to see the difference revisions added.

Table. 1 Latest revision for GN-10 is version 3.5 and it shows the following changes from the previous version

Implication of Changes

HSA clarifies that manufacturers who will do MDRR3 reporting for a device that is clinically needed in SG will need to undergo review and approval prior selling. In addition, manufacturer will also submit a MDRR1 report for the same device to HSA. 

For FSCAs to be reported under MDRR1, FSNs are required to be copied to relevant officials of the affected healthcare facilities.

Health Sciences Authority-Regulatory Guidance for GN-10