On 1 October 2026, the Health Sciences Authority (HSA) of Singapore implemented the “Guidance on Medical Device Product Registration” (GN-15, Revision 15), and concurrently published the “Premarket Submission Checklist for Medical Device Product Registration Submission” (MD-01 R1).
The update involves two principal changes:
• the premarket submission checklist is now incorporated as a formal submission requirement for certain medical device registration routes; and
• the qualification criteria for certification bodies issuing ISO 13485 certificates are clarified.
1. Regulatory Documents
| Document | Reference | Link |
| Medical Device Product Registration Guide** GN-15: Guidance on Medical Device Product Registration, Revision 15 | Issued 30 September 2026 | file.go.gov.sg/gn-15-r15-30-09-2026.pdf |
| Premarket Submission Checklist for Medical Device Product Registration Submission** MD-01 R1 | Effective 1 October 2026 | file.go.gov.sg/premarketsubmissionchecklist-2026oct.pdf |
2. Registration Routes Requiring the Premarket Submission Checklist
| Device Class | Registration Routes Requiring Submission of the Premarket Submission Checklist |
| Class B | Full Evaluation Abridged Evaluation |
| Class C | Full Evaluation Abridged Evaluation Expedited Class C Registration (ECR-1 / ECR-2) |
| Class D | Full Evaluation Abridged Evaluation Expedited Class D Registration (EDR) |
3. Premarket Submission Checklist
The checklist comprises 13 sections covering the principal technical documents for medical device product registration.
| Section | Submission Document | Key Content and Requirements |
| Section 1 | Letter of Authorisation | A letter of authorisation meeting the requirements, the scope of which must cover all product models and configurations applied for registration. |
| Section 2 | List of Configurations | Use the latest Annex 2 Excel template, listing models, specifications, accessories and software versions; complete document mapping must be provided for implant systems. |
| Section 3 | Reference Agency Approval | Submit the applicable foreign registration certificate, approval letter and conformity assessment evidence, such as CE, MHLW or MDA-related documents. |
| Section 4 | Declarations | Submit the declaration of differences, the adverse event (AE) declaration and the field safety corrective action (FSCA) declaration, together with the applicable listing history and safety declaration. |
| Section 5 | Executive Summary | Describe the intended use, working principle, technical characteristics, global listing history, overseas registration status and related regulatory information. |
| Section 6 | Essential Principles Checklist and Declaration of Conformity | Submit the applicable Essential Principles Checklist and the Declaration of Conformity, demonstrating that the device meets the relevant safety and performance requirements. |
| Section 7 | Device Description | Provide the product technical principles, functions, classification rationale, technical specifications, accessories, contact materials, and comparison data with equivalent devices (where applicable). |
| Section 8 | Design Verification and Validation | Submit the applicable biological compatibility, sterility, shelf life, electrical safety, EMC, software, cybersecurity, mechanical and performance testing and IVD analytical performance data. |
| Section 9 | Clinical Evaluation Report | Submit the clinical evaluation report supporting the safety and effectiveness of the device, including literature documents, clinical experience, clinical studies and IVD clinical performance data (where applicable). |
| Section 10 | Device Labelling | Submit device labels, package labels and instructions for use (IFU), and ensure the labels cover the registered product models and configurations. |
| Section 11 | Risk Management | Submit the risk analysis and risk management report, stating risk identification, risk control measures and the acceptability of the residual risks. |
| Section 12 | Manufacturing Information | Submit manufacturing site information, contract manufacturing or sterilisation site information, quality management system certification (such as ISO 13485 or MDSAP), and the manufacturing process flow diagram. |
| Section 13 | Others | Submit documents that cannot be placed under the above sections but are required for the registration review. |
4. Qualification Requirements for ISO 13485 Certification Bodies
The certification body issuing an ISO 13485 certificate must satisfy one of the following conditions:
• it is accredited by an Accreditation Body recognised by Global ACI; or
• it is an EU MDR / IVDR Notified Body.
Companies intending to use an ISO 13485 certificate as evidence of the quality management system for medical device registration in Singapore should verify in advance that the qualification of the body issuing the certificate meets HSA requirements.
5. Submission Considerations
The premarket submission checklist places particular emphasis on the completeness of application documents and on compliance with the document submission conventions in the SHARE system.
| Key Item | Specific Requirement |
| Checklist completeness | The Checklist must be filled in completely and submitted together with the applicable registration application. |
| Product configuration consistency | The models, identifiers and quantities in Annex 2 must be consistent with what is held in the SHARE system. |
| Implant system document mapping | Document mapping must cover the complete implant system and the related attachments. |
| Upload location for documents | Documents must be uploaded to the corresponding folder in the SHARE system and must not be placed indiscriminately into other folders. |
| Non-applicable items | Items in Section 8 that are not applicable should state the specific reason. |
| Placeholder documents | Blank documents or placeholder documents such as “To be provided later” must not be used in place of formal documents. |
| Use of the Section 13 “Others” column | Section 13 is to be used only for necessary documents that cannot be placed under any other appropriate section. |
A registration application should not be submitted until the required documents are complete. Incomplete applications will be rejected and the application fees already paid will not be refunded.
6. Implications for Medical Device Companies
Companies planning to apply for medical device registration in Singapore should, based on the product class and registration route, confirm whether the premarket submission checklist must be submitted; check in advance the completeness of the application documents, the consistency of the product configuration and the upload status in the SHARE system. Companies using ISO 13485 certificates as evidence of the quality management system should also confirm that the qualification of the certification body meets HSA requirements, so as to avoid the registration application being affected by incomplete documents or by a certification body whose qualification does not meet the requirements.