According to HSA, some applicants have been creating new POs even though an existing PO is on the MEDICS database. Such actions will result in the creation of a new PO ID number and will cause issues during the submission of FSC and/or Change of Registrant application. Thus, the applicant will be unable to select all Singapore Medical Device Register (SMDR) listings due to a new different PO ID.
In order, to address this issue, the HSA has informed the applicants to apply for a Change Notification (CN) should they need to amend the existing PO ID. The type of CN will be “Amendment Changes for Correction of Typographic Errors on SMDR (Verified by HSA Prior to Submission).” The following are the procedures for submitting this CN type:
- 1. Select “Other Change(s) – Applicable only upon receipt of email from HSA, authorizing submission under this category” in MEDICS.
- 2. Under “Other Change(s),” select “Amendment Changes for correction of typographic errors on SMDR” (Verified by HSA prior to submission).
- 3. Upload the Annex 2 Summary Table of Changes in MEDICS.
- 4. Update Product Owner Code under Product Owner Info section in MEDICS for the required SMDR device listing(s).
- 5. Submit a screenshot of the selected Product owner with the Product Owner code for verification.
HSA strongly encourages applicants to search first for the existing PO ID before creating a new one.
Product Owner Information in MEDICS