PRODUCT REGISTRATION SUBMISSION GUIDE E-Submission Guide for In Vitro Diagnostic Medical Devices for ASEAN CSDT and IMDRF ToC based Submissions in SHARE Revision 4 OCTOBER 2025 MEDICAL DEVICE SUBMISSION GUIDE OCTOBER 2025 GL-18-R4 Page 2 of 14
1. INTRODUCTION
1. INTRODUCTION
1.1. Purpose
1.1 Purpose This document is intended to provide guidance on submission of a product registration dossier to HSA via the R4► Singapore Health Product Access and Regulatory E-System (SHARE). This guide specifies the appropriate folders in SHARE for uploading of the corresponding sections of the CSDT or IMDRF ToC dossier. ◄
1.2. Background
1.2 Background Product registration applications for medical devices are submitted online to HSA and may be compiled and prepared from the ASEAN Common Submission Dossier Template (CSDT) or the International Medical Device Regulators Forum (IMDRF) In Vitro Diagnostic Device Market Authorization Table of Contents (IVD MA ToC). Applications must be submitted online to HSA via SHARE. The technical dossier and supporting documents shall be submitted in softcopy in SHARE.
1.3. Scope
1.3 Scope This document applies to in vitro diagnostic medical devices only.
2. SUBMISSION GUIDELINES
2. SUBMISSION GUIDELINES
2.1. SHARE application form
2.1 SHARE application form The technical dossier and supporting documents are to be submitted under the ‘Supporting Documents’ section of the SHARE application form. This section of the application form comprises several folders for uploading the documents. To facilitate review of the pre-market application, applicants shall ensure that the relevant section of the dossier and supporting documents are uploaded correctly under each folder. Document file names should also be meaningful and provide some indication of their content. The “SHARE application form” column in TABLE 1 lists the various folders in the ‘Supporting Documents’ section of the SHARE application form and includes a brief description of the expected contents to be uploaded under each of the folders.
2.1.1. Submissions based on CSDT
2.1.1 Submissions based on CSDT Please refer to “CSDT TR-02” column of TABLE 1 to determine which sections of the CSDT are to be uploaded under each folder in SHARE. MEDICAL DEVICE SUBMISSION GUIDE OCTOBER 2025 GL-18-R4 Page 4 of 14
2.1.2. Submissions based on IMDFR nIVD ToC
2.1.2 Submissions based on IMDFR nIVD ToC Please refer to “IMDRF IVD ToC” column of TABLE 1 to determine which sections of the ToC are to be uploaded under each folder in SHARE.
2.2. Submitting responses to Input request queries via SHARE
2.2 Submitting responses to Input request queries via SHARE To facilitate identification and review of information uploaded onto SHARE in response to queries raised during the evaluation process, a written response to each input request query shall be provided. If additional documents are submitted to support your response, please indicate the relevant file name(s) in your response. R4► Applicants may respond to input requests by selecting "Reply", navigating directly to the relevant section by selecting "Go to section", or consolidating their response within a separate document for formal submission to HSA. ◄
2.3. Reference documents
2.3 Reference documents Product Registration Submission Document Location Based on the ASEAN CSDT GN-18: Guidance on Preparation of a Product Registration Submission for In Vitro Diagnostic Medical Devices using the ASEAN CSDT TR-02: Contents of a Product Registration Submission for In Vitro Diagnostic Medical Devices using the ASEAN CSDT www.hsa.gov.sg Based on the IVD MA ToC IMDRF In Vitro Diagnostic Medical Device Market Authorization Table of Contents (IVD MA ToC) www.imdrf.org MEDICAL DEVICE SUBMISSION GUIDE OCTOBER 2025 GL-18-R4 Page 5 of 14
3. TABLE 1 – SUMMARY OF SUBMISSION REQUIREMENTS
3. TABLE 1 – SUMMARY OF SUBMISSION REQUIREMENTS Legend: F Full evaluation route A Abridged evaluation route E Expedited evaluation route I Immediate registration route SHARE Application Form - Supporting Documents Reference technical documents Class B Class C & D IMDRF IVD ToC CSDT TR-02 F A I F A E I 1 Letter of authorization ▪ Letter of Authorisation of Registrant by the Product Owner for all the products to be registered, using the latest template as per GN-15 Annex 1 Letter of Authorisation template CH1.13 Letter of Authorization NA ✓ ✓ ✓ ✓ ✓ ✓ ✓ 2 Annex 2 List of Configurations ▪ A copy of Annex 2 for GN17 and GN18 List of Configurations, including the complete list of configurations of medical devices subject to the submission. This is to be submitted in a Microsoft Excel file. CH1.05 Listing of Device(s) 4.2 Device Description ✓ ✓ ✓ ✓ ✓ ✓ ✓ 3 Proof of reference agency's approval(s) ▪ Copies of approval letter(s) from each reference agency. For CE marked devices, the EU declaration of conformity by the product owner must be submitted, in addition to the EC certificate issued by the notified bodies. CH1.07 Free Sale Certificate/ Certificate of Marketing authorization 3. Executive Summary ✓ ✓ ✓ ✓ ✓ 4 R4► Declarations 4.1 R4► Declaration of Labelling ▪ Declaration from product owner that labelling, packaging and IFU of the device for sale in Singapore are identical or not identical to that approved by reference agency being used as the basis for evaluation route. If not identical, please provide a description of the differences. CH2.6 Global Market History CH2.2 General Summary of Submission 3. Executive Summary ✓ ✓ ✓ ✓ ✓ ✓ ✓ MEDICAL DEVICE SUBMISSION GUIDE OCTOBER 2025 GL-18-R4 Page 6 of 14 SHARE Application Form - Supporting Documents Reference technical documents Class B Class C & D IMDRF IVD ToC CSDT TR-02 F A I F A E I 4.2 R4► Marketing History Declaration ▪ Invoice with date, proof of sale or a declaration on Marketing history as per Annex 2 of GN-15, to be completed by the local Applicant NA NA ✓ Only required for Condition 1 ✓ Only required for ECR1 ✓ 4.3 R4► Safety Declaration ▪ Safety declaration template as per Annex 3 of GN-15, to be completed by the local Applicant NA NA ✓ ✓ Only required for ECR1 ✓ 4.4 R4► AE and FSCA Summary or Attestation ▪ To include a summary of reportable adverse events (AEs) and field safety corrective actions (FSCAs) for the medical device since its first introduction on the global market, in a tabular format as per TR-02. ▪ For FSCAs that are ‘open’, provide a description of any analysis and/or corrective and preventive actions undertaken by the product owner. ▪ If there have been no adverse events or FSCAs to date, provide an attestation from product owner on company letterhead, that there have been no adverse events or FSCAs since commercial introduction of the device globally. This attestation is not restricted to usage only as intended by the product owner. 5 Executive Summary ▪ Introductory descriptive information on the medical device, the intended use and indications for use of the device. CH2.6 Global Market History CH2.2 General Summary of Submission 3. Executive Summary ✓ ✓ ✓ ✓ ✓ ✓ ✓ ▪ Information on the use of the device, if any, such as targeted patient population, user profile (e.g. specific trained users), specific disease status or clinical condition (e.g. monitoring of a disease), assay principle (e.g. immunoassay) etc. ▪ If the medical device has any unique or novel feature or characteristic (e.g. nanotechnology), a description must be provided. ▪ Any high-level background information or details that the product owner wishes to highlight in relation to the device, its history or relation to other approved devices (e.g. predicate devices) or previous submissions (provides context to submission). ▪ List of countries from HSA’s reference regulatory agency jurisdictions where the medical device is marketed. MEDICAL DEVICE SUBMISSION GUIDE OCTOBER 2025 GL-18-R4 Page 7 of 14 SHARE Application Form - Supporting Documents Reference technical documents Class B Class C & D IMDRF IVD ToC CSDT TR-02 F A I F A E I ▪ Date (accurate to MMYYYY) and country where the device was first introduced for commercial distribution, globally. ▪ Registration status (i.e. submitted, not submitted, pending approval, rejected or withdrawn) and approved intended use and indications of the medical device in HSA’s recognised reference agencies, in a tabular format as per TR-02. If device is withdrawn/ rejected by any reference agencies, reason for rejection or withdrawal is to be provided. ▪ Declaration from product owner that labelling, packaging and IFU of the device for sale in Singapore are identical or not identical to that approved by reference agency being used as the basis for evaluation route. If not identical, please provide a description of the differences. ▪ If the subject device is different in any way (e.g. design, commercial name, specifications, intended use and indications for use) from those approved by the reference agencies, the differences should be described. 6 Essential Principles Checklist and Declaration of conformity ▪ Essential Principles conformity checklist (EP checklist). The checklist of conformity to the Singapore Essential Principles is to be submitted. Alternatively, the checklist to EU or Australian Essential Requirements can be submitted. CH1.11.6 Declaration of Conformity CH3.3 Essential Principles (EP) Checklist CH3.4 Standards 4.1. Relevant Essential Principles and Method Used to Demonstrate Conformity NOTE: Refer to GN-16 Guidance on Essential Principles for Safety and Performance of Medical Devices for more details. ✓ ✓ ✓ ✓ ✓ ▪ GN-11 Declaration of Conformity (DOC). Alternatively, the EC or AU DOC can be submitted. ▪ List the standards that have been complied with in the design and manufacture (including sterilization) of the device, if this has not been provided in the EP checklist or DOC. 7 R4► Device description ▪ A comprehensive description of the device including technology, functionalities, features and connectivity capabilities (e.g. wireless enabled, Bluetooth enabled, internet-connected and network-connected devices) if applicable. To include labelled pictorial representation (diagrams, photos, drawings) if applicable. CH2.4 Device Description CH2.5 Indications for Use and/or Intended 4.2 Device Description ✓ ✓ ✓ ✓ ✓ ✓ ✓ MEDICAL DEVICE SUBMISSION GUIDE OCTOBER 2025 GL-18-R4 Page 8 of 14 SHARE Application Form - Supporting Documents Reference technical documents Class B Class C & D IMDRF IVD ToC CSDT TR-02 F A I F A E I ▪ Risk class and applicable classification rule for the medical device according to the Regulations. Use and Contraindications ▪ Product specifications including the version number of the software if applicable. ▪ List of medical device accessories intended to be used in combination with the devices. Accessories that can be sold separately should be identified and listed in the Annex 2 list of configurations if intended to be supplied in Singapore. ▪ Where safety and effectiveness data of similar or previous generation devices are used in the current submission, the following information is to be provided: o A list of such devices and specific information on the registration status of these devices with HSA are to be included (e.g. Device registration number). ▪ A comparison, preferably in a table, of the design, specifications and intended use/indications for use between the subject device in the current submission and the comparator devices (similar and/or previous generation). To include labelled pictorial representation (diagrams, photos, drawings) where necessary. ▪ An indication of biological material or derivate used in the medical device, its origin and source/donor. ▪ Process validation results to substantiate that manufacturing procedures are in place to minimise biological risks, in particular, with regard to viruses and other transmissible agents. This also includes inactivation of infectious organisms in reagents and the production of reagents. R3► ▪ Summary of software development life cycle process including processes in place to manage the various life cycle activities ▪ Software Requirements Specification documenting functional, performance, interface, design, developmental, and other requirements for the software 8 R4► Design verification and validation documents including ▪ Preclinical studies e.g. physical test data, biocompatibility studies, animal studies and software verification and validation studies ▪ Metrological requirements ▪ Sterilisation validation (if applicable) ▪ Shelf-life studies and projected useful life 8.1 R4► Biocompatibility CH3.5 Non-clinical Studies 4.3 Summary of Design Verification and ✓ Detailed reports ✓ Summary ✓ Sterilisation validation for ✓ Detailed reports ✓ Summary ✓ Summary ✓ Software verification and ▪ Studies supporting biocompatibility and assessing toxicology. If biocompatibility tests that are recommended MEDICAL DEVICE SUBMISSION GUIDE OCTOBER 2025 GL-18-R4 Page 9 of 14 SHARE Application Form - Supporting Documents Reference technical documents Class B Class C & D IMDRF IVD ToC CSDT TR-02 F A I F A E I by ISO 10993 were not performed, adequate justification must be provided. ▪ For non-IVD medical device accessories to be registered with the IVD medical device e.g. a lancet that is provided in the package to the user to perform a test, information on preclinical studies such as biocompatibility and sterilisation validation necessary to establish the safety and performance of these medical devices shall be provided. CH3.6 Other Studies CH3.7 Analytical Performance and Other Evidence Bibliography CH3.8 Other non- clinical Evidence Validation Documents Sterile devices only Software verification and validation studies for standalone medical mobile applications only Evidence to support the cybersecurity of connected medical devices validation studies for standalone medical mobile applications only Evidence to support the cybersecurity of connected medical devices 8.2 R4► Sterilisation ▪ For non-IVD medical device accessories to be registered with the IVD medical device e.g. a lancet that is provided in the package to the user to perform a test, information on preclinical studies such as biocompatibility and sterilisation validation necessary to establish the safety and performance of these medical devices shall be provided. 8.3 R4► Shelf Life ▪ Specify the claimed shelf life of the device components (e.g. reagents, calibrators/reference materials, control material, any other components susceptible to degradation). ▪ Evidence supporting the claimed shelf-life of device components. If applicable, both real time and accelerated stability studies are to be submitted. If real time aging has not been performed, adequate justification must be provided. ▪ Evidence supporting the stability during actual routine use of the device (real or simulated), including all applicable components (e.g. reagents, reaction cartridges). ▪ Information regarding and studies to support the stability of all of the sample type(s) identified in the labelling, including any and all recommended additives (e.g. anticoagulants). ▪ For IVD medical device that does not have expiry dates, the projected useful life of the device. 8.4 R4► Electrical Safety R4► ▪ If applicable, evidence supporting electrical safety. For example, if a device is claimed to meet the requirements of IEC 61010-1, summary test reports and/or certificates are to be submitted for verification of conformance to these standards. 8.5 R4► Electromagnetic Compatibility MEDICAL DEVICE SUBMISSION GUIDE OCTOBER 2025 GL-18-R4 Page 10 of 14 SHARE Application Form - Supporting Documents Reference technical documents Class B Class C & D IMDRF IVD ToC CSDT TR-02 F A I F A E I R4► ▪ If applicable, evidence supporting electromagnetic compatibility. For example, if a device is claimed to meet the requirements of IEC 61326-1, summary test reports and/or certificates are to be submitted for verification of conformance to these standards 8.6 R4► Software R4► ▪ Specify the version of the software to be supplied. NOTE: The exact software version that represents all software changes/iteration (e.g. graphic interface, functionality, bug fixes and etc.) should be provided. Software version numbering that is solely for testing or internal use are not required. ▪ An overview of all verification, validation and testing performed for the software both in-house and in a simulated or actual user environment prior to final release. Where the software has been validated together with the IVD instruments (e.g. IVD analysers), reports of such validation addressing the safety and performance considerations for the software is to be provided. NOTE: The version tested must be clearly identified and should match the release version of the software, otherwise to provide justification. ▪ All unresolved anomalies in the release version of the software should be summarized, along with a justification for acceptability (i.e. the problem, impact on safety and effectiveness, and any plans for correction of the problems). ▪ Traceability Analysis linking product design requirements, design specifications, and testing requirements. Identified hazards should be tied to implementation and testing of the mitigations. 8.7 R4► Cybersecurity ▪ Evidence to support the cybersecurity of connected medical devices such as wireless enabled, Bluetooth enabled, internet-connected and network-connected devices. For example, but not limited to: o Cybersecurity vulnerabilities and risks analysis o Cybersecurity control measures o Security test reports and/or evidence to verify the device cybersecurity and effectiveness of the implemented cybersecurity control measures (not applicable to IBR & ICR applications). MEDICAL DEVICE SUBMISSION GUIDE OCTOBER 2025 GL-18-R4 Page 11 of 14 SHARE Application Form - Supporting Documents Reference technical documents Class B Class C & D IMDRF IVD ToC CSDT TR-02 F A I F A E I o On-going plans, processes or mechanisms for surveillance, timely detection and management of the cybersecurity related threats during the useful life of the device, especially when a breach has been detected. 8.8 R4► Machine Learning R4► ▪ Refer to GL-04 Regulatory Guidelines for Software Medical Devices including Machine Learning-Enabled Medical Devices – A Life Cycle Approach. 8.9 R4► Bench Testing ▪ If applicable, evidence supporting the physical or mechanical properties of the subject device 8.10 R4► IVD Pre-clinical Requirements ▪ Evidence supporting the analytical performance (e.g. analytical sensitivity, analytical specificity and interference, precision, linearity/assay’s measuring range/hook effect, traceability and expected values, cut-off value, trueness, specimen stability, performance characteristics for instrument) of the subject device. 8.11 R4► Biological Material R4► ▪ If applicable, description and purpose of the biological material or derivate used in the medical device and in the manufacturing process of the medical device. ▪ If applicable, process validation results to substantiate that manufacturing procedures are in place to minimise biological risks, with regard to viruses and other transmissible agents. This also includes inactivation of infectious organisms in reagents and the production of reagents. 9 R4► Clinical Evaluation Report ▪ A clinical evaluation report reviewed and signed by an expert in the relevant field that contains an objective critical evaluation of all of the clinical data submitted in relation to the device. Clinical evidence should include the following: o Clinical (Diagnostic) Sensitivity o Clinical (Diagnostic) Specificity o Method Comparison o Matrix Comparison o Clinical Cut-off o Reference Interval (Expected values) CH4.2 Overall Clinical Evidence Summary CH4.5 Other Clinical Evidence 4.3.2. Clinical Evidence NOTE: Refer to GN-20 Guidance on Clinical Evaluation for more details If applicable If applicable If applicable ✓ ✓ ✓ If applicable MEDICAL DEVICE SUBMISSION GUIDE OCTOBER 2025 GL-18-R4 Page 12 of 14 SHARE Application Form - Supporting Documents Reference technical documents Class B Class C & D IMDRF IVD ToC CSDT TR-02 F A I F A E I o Additional requirements for IVD medical device for self-testing and near patient testing (if applicable) ▪ R2► For IVD medical device undergoing full evaluation, clinical evaluation conducted by independent third parties (e.g. accredited clinical laboratories) may be required. 10 R4► Device Labelling 10.1 R4► Device Labels ▪ Primary and secondary labels in their original colour for the device and its accessories as applicable. CH5.2 Product/Package Labels 4.4 Device Labelling NOTE: Refer to GN-23 Guidance on Labeling for Medical Devices for more details. ✓ ✓ ✓ ✓ ✓ ✓ ✓ ▪ If representative labels are provided, variable fields on the artwork must be highlighted, and ranges of values for the variable fields should be indicated. 10.2 R4► Instructions for Use ▪ Copy of the IFU to be supplied in Singapore for the device and its accessories as applicable. CH5.3 Package Insert/ Instructions for Use CH5.4 e-labelling CH5.5 Patient Labelling CH5.6 Technical/Operator Manual 4.4 Device Labelling NOTE: Refer to GN-23 Guidance on Labeling for Medical Devices for more details. ✓ ✓ ✓ ✓ ✓ ✓ ✓ ▪ Indicate format of the IFU to be supplied with every medical device e.g. paper or electronic. 11 R4► Risk Management ▪ Risk analysis describing the risks identified, severity of harm and probability of occurrence including the mitigation measures. A risk management report to substantiate that all known and foreseeable risks, including cybersecurity risks if applicable, have been reasonably mitigated and the CH3.2 Risk Management 4.5 Risk Analysis ✓ ✓ ✓ ✓ ✓ MEDICAL DEVICE SUBMISSION GUIDE OCTOBER 2025 GL-18-R4 Page 13 of 14 SHARE Application Form - Supporting Documents Reference technical documents Class B Class C & D IMDRF IVD ToC CSDT TR-02 F A I F A E I residual risks have been reduced or controlled to an acceptable level is to be submitted. 12 R4► Manufacturing Information (sites name and address) 12.1 R4► Site Information ▪ Name and address for all manufacturing and sterilisation sites (including contract manufacturers and contract sterilisers). CH6A.3.2 General Manufacturing Information 4.6. Manufacturer Information ✓ ✓ ✓ ✓ ✓ ✓ ✓ 12.2 R4► Quality Management System Certificate - E.g.: ISO13485 Certificate, R2► MDSAP Certificate, Conformity to US FDA Quality System Regulations or Japan MHLW Ordinance 169 ▪ ISO 13485 R2► or MDSAP certificates are to be provided for manufacturing and sterilisation sites of finished devices. R4►Certification bodies for ISO 13485 must be either accredited by IAF recognised accreditation bodies or are EU MDR/IVDR Notified Bodies. o R2► For refurbished devices, refurbishment process must be covered within the scope of the QMS certificate of the manufacturer. CH1.06 Quality Management System, Full Quality System or Other Regulatory Certificates 4.6. Manufacturer Information ✓ ✓ ✓ ✓ ✓ ✓ ✓ ▪ For sites without ISO 13485 R2► or MDSAP certification, comparable audit reports for the actual site e.g. US FDA Quality Systems Regulations or Japan MHLW Ordinance 169 can be submitted. 12.3 Manufacturing Process Flowchart ▪ Manufacturing process flow diagram. CH6B.6.3 Production and service controls information 4.6. Manufacturer Information ✓ ✓ ✓ ✓ 13 Other document, please specify ▪ Information on previous regulatory decisions (e.g. withdrawals or rejections by HSA) for the devices NOTE: You may be required to provide the previous submission or registration information where necessary. CH1.09 Pre- Submission Correspondence and Previous Regulator Interactions NA If applicable If applicable If applicable If applicable If applicable If applicable If applicable ▪ Information on any ongoing AE or FSCA reported to HSA for the subject device. ▪ Justification for an unmet clinical need NOTE: Applicable for Priority Review Scheme Route 1 Contact Information: Medical Devices Cluster Health Products Regulation Group Health Sciences Authority 11 Biopolis Way, #11-03 Helios Singapore 138667 www.hsa.gov.sg
