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October 16, 2025
Approximately 5 minutes
Medical Device Labeling: HSA Compliance and AMDD Harmonization
Singapore Medical Device Labeling: HSA Compliance and AMDD Harmonization
Medical device and In Vitro Diagnostic (IVD) labeling in Singapore is governed by the Health Sciences Authority (HSA), primarily through GN-23: Guidance on Labelling for Medical Devices. The requirements are largely harmonized with the ASEAN Medical Devices Directive (AMDD) principles.
General Labeling Requirements
- Language: All product labeling, including the main label and Instructions for Use (IFU), must be in English.
- Principle: The label must be of a reasonable size for the device type and contain sufficient information for the user to safely identify and use the product.
- Instructions for Use (IFU): IFUs are generally required, but may be omitted for certain low-risk devices. Additional information that cannot fit on the device label must be included in the IFU or inside the packaging.
Required Label Content for All Devices (MD and IVD)
The label for both general medical devices and IVDs must include the following key pieces of information:
- Product Owner Details: Name, address, and telephone number of the product owner/manufacturer.
- Trade/Brand Name: The commercial name of the device.
- Identification Details: Information clearly identifying the specific device.
- Batch/Lot Number: For traceability purposes.
- Expiration Date: If applicable to the device or its components.
- Sterilization Status: Indication of whether the product is Sterile or Non-Sterile.
- Warnings/Precautions: Warnings regarding potential malfunctions, precautions, and proper disposal methods.
- Specific Requirements: Any additional requirements based on device characteristics (e.g., single-use only, implantable device, radiation-emitting, custom-made).
Specific Requirements for IVD Devices
In addition to the general requirements, IVD products must adhere to extra mandatory information related to their diagnostic function, including:
- Intended Purposes: Specific details on the analyte, whether the test is qualitative or quantitative, and the clinical application.
- Test Principle: The scientific or methodological basis of the assay.
- Assay Procedure: Clear instructions, including calculation steps and interpretation guidelines.
- Performance Characteristics: Data on the test's performance, such as sensitivity and specificity.
- Specimen Type: The type of sample required (e.g., blood, urine, tissue).
- Collection Conditions: Instructions on the conditions for specimen collection.
- Reference Intervals: The established normal ranges or cut-off values.
- Reagent Description and Limitations: A description of the reagents used and any known limitations of the test or study design.
Compliance with these precise labeling rules is part of the HSA's product review process, ensuring market safety.
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