| AE | Adverse Event. An undesirable occurrence associated with a medical device that could have resulted in, or did result in, patient or user harm. |
| AMDC | ASEAN Medical Device Committee. The body responsible for harmonising medical device regulation across ASEAN member states. Singapore participates actively. |
| AMDD | ASEAN Medical Device Directive. The ASEAN framework document for harmonising medical device regulation across member states. |
| Change notification | A mandatory submission to HSA before implementing changes to a registered device's design, labelling, manufacturing, or other registered details. |
| Class A / B / C / D | Singapore's four-tier risk classification for medical devices. Class A is lowest risk (exempt from registration). Class D is highest risk (most stringent evaluation). |
| CSDT | Common Submission Dossier Template. An ASEAN initiative to standardise the format and content of medical device registration dossiers across ASEAN member states. |
| Dealer | Any entity that manufactures, imports, or wholesales medical devices in Singapore. All dealers must hold a dealer's licence. |
| Dealer's licence | A licence issued by HSA authorising a specific entity to manufacture, import, or wholesale medical devices in Singapore. Three types: manufacturer's, importer's, and wholesaler's. |
| ECR | Expedited Class C Registration. A streamlined evaluation route for Class C devices meeting specific conditions relating to overseas reference agency approvals and safe marketing history. |
| EDR | Expedited Class D Registration. The equivalent expedited route for Class D devices. |
| FSCA | Field Safety Corrective Action. An action taken by a manufacturer or its representative to reduce a risk of death or serious deterioration in health associated with a medical device already on the market. Includes recalls, device modifications, and user notices. |
| FSCA notice | A written communication from a manufacturer to users, healthcare professionals, or distributors informing them of an FSCA and the actions required. |
| GDP | Good Distribution Practice. Standards for the storage, handling, and distribution of medical devices to ensure they maintain their safety and performance from manufacturer to end user. Required for all licensed importers and wholesalers. |
| HPA | Health Products Act (Cap. 122D). Singapore's primary legislation for the regulation of health products, including medical devices. |
| HP(MD) Regulations | Health Products (Medical Devices) Regulations 2010. The subsidiary legislation under the HPA that provides the detailed regulatory requirements for medical devices. |
| HPRG | Health Products Regulation Group. The division of HSA responsible for regulating medical devices, therapeutic products, and other health products. |
| HSA | Health Sciences Authority. Singapore's national regulatory authority for health products, a statutory board under the Ministry of Health. |
| IBR | Immediate Class B Registration. A very fast evaluation route for Class B devices meeting specific conditions. Also available for standalone software as a medical device (SaMD) of Class B or C. |
| IMDRF | International Medical Device Regulators Forum. A voluntary group of medical device regulatory authorities (including HSA) working to harmonise regulatory requirements globally. |
| Input Request (IR) | A request from HSA to an applicant for additional information or clarification during the evaluation of a registration application. Responding promptly to IRs is important to avoid delays. |
| IVD | In Vitro Diagnostic medical device. A device used to examine specimens derived from the human body (e.g. blood, urine, tissue) for diagnostic purposes. |
| MDMIS | Medical Device Manufacturers Information System. The HSA e-portal for submitting adverse event reports. |
| Overseas reference regulatory agency | One of five agencies whose approvals HSA recognises for abridged, expedited, and immediate evaluation routes: TGA (Australia), EU Notified Bodies, Health Canada, MHLW (Japan), and US FDA. |
| PMS | Post-Market Surveillance. The systematic process of collecting, recording, and analysing data on the performance and safety of a medical device after it has been placed on the market. |
| PRISM | The legacy HSA e-portal for health product submissions, now replaced by SHARE. References to PRISM in older documents should be understood as referring to SHARE. |
| Priority Review Scheme | An HSA scheme that allows faster registration for full-evaluation-route devices that address unmet clinical needs or provide significant health benefits. |
| Product notification | The administrative submission required for Class A devices in lieu of product registration. Submitted via SHARE. |
| QMS | Quality Management System. A documented system for managing quality across an organisation's processes. For medical device dealers in Singapore, an ISO 13485-aligned QMS is required. |
| Registrant | The Singapore-registered entity that holds a product registration on the SMDR and is accountable for ongoing post-market compliance of that registered device. |
| SaMD | Software as a Medical Device. Software that meets the definition of a medical device under the HPA — typically software that diagnoses, treats, monitors, or predicts a medical condition without being part of a hardware device. |
| SHARE | Submission of Health products And Registration via E-portal. The HSA online portal used for all regulatory transactions including product registration, Class A notifications, dealer's licence applications, and adverse event reporting. |
| SMDR | Singapore Medical Device Register. The official register of all medical devices registered for supply in Singapore, maintained by HSA. |
| Special Access Route (SAR) | A pathway allowing unregistered devices to be supplied in Singapore under specific limited circumstances (e.g. for a qualified practitioner's patient, for a licensed healthcare facility, for re-export, or during a public health emergency). |
| TAT | Turnaround Time. The time HSA takes to complete the evaluation of a registration application, measured from receipt of a complete submission. TAT varies by evaluation route and device class. |
| TGA | Therapeutic Goods Administration. Australia's national regulatory authority for medical devices. TGA approval is one of the five recognised overseas approvals for abridged/expedited/immediate routes. |
| UDI | Unique Device Identifier. A system for assigning a unique label or identifier to medical devices to allow unambiguous identification in the supply chain and in healthcare settings. HSA references IMDRF UDI guidance. |