The Singapore Health Sciences Authority (HSA) has released Revision 15 of GN-15: Guidance on Medical Device Product Registration, introducing a new Premarket Submission Checklist as a mandatory component of selected medical device registration applications.
The update strengthens HSA’s focus on dossier completeness and submission readiness before applications proceed to technical evaluation.
Applicants using the affected registration routes should ensure that all required administrative, technical, and supporting documentation is complete and properly organized at the time of submission.
Read the updated guidance here:
https://file.go.gov.sg/gn-15-r15-30-09-2026.pdf
Purpose of the Update
To strengthen the completeness and quality of medical device registration dossiers submitted to HSA.
The new Premarket Submission Checklist serves as a verification tool to help applicants confirm that applicable documentary requirements have been addressed before an application progresses to evaluation.
Scope of Application
The Premarket Submission Checklist is required for the following registration pathways:
Class B Medical Devices
Required for:
- Full Evaluation Route
- Abridged Evaluation Route
The checklist is not required for the IBR Route.
Class C and D Medical Devices
Required for:
- Full Evaluation Route
- Abridged Evaluation Route
- Expedited Class C Registration (ECR) Route
- Expedited Class D Registration (EDR) Route
The checklist is not required for the ICR Route.
Key Update
Premarket Submission Checklist Introduced
The Premarket Submission Checklist has been incorporated into:
- Annex 6 for Class B medical device registrations
- Annex 8 for Class C and D medical device registrations
Applicants using the applicable registration routes must include the relevant checklist as part of the registration dossier.
The checklist is intended to confirm that the required technical, administrative, and supporting documents are available and appropriately organized before HSA begins technical evaluation.
Application Screening and Dossier Completeness
Applications must satisfy all mandatory documentation requirements before progressing from the Application Stage to the Evaluation Stage.
An incomplete dossier may be rejected during initial screening. Where this occurs:
- The application will not proceed to technical evaluation.
- The SGD 560 application fee will be forfeited and is non-refundable.
- Registration timelines may be delayed if a new application must be prepared and submitted.
The update therefore increases the importance of conducting a comprehensive dossier review before submission.
Implications to Clients
Product Owners and regulatory stakeholders preparing medical device registrations in Singapore should incorporate the new Premarket Submission Checklist into their dossier preparation and internal review processes for applicable pathways.
Before submitting a new application, companies should:
- Confirm whether the selected registration route requires the checklist.
- Conduct a completeness review of the registration dossier.
- Ensure all required administrative, technical, and supporting documents are available and properly organized.
- Verify that supporting documents meet the applicable HSA requirements.
- Update internal submission procedures and templates to reflect GN-15 Revision 15 and the applicable GN-17/GN-18 requirements.
Complete and accurate documentation should be provided before submission to reduce the risk of screening deficiencies, application rejection, additional costs, and delays.
Effective Date
1 October 2026
For Inquiries
For inquiries or support regarding medical device regulatory requirements in Singapore, please contact sales@andamanmed.com.