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Singapore Medical Device Labeling
Medical device labeling requirements in Singapore are addressed by the Health Science Authority‘s (HSA) GN-23: Guidance on Labelling for Medical Devices and are largely harmonized with the ASEAN Medical Devices Directive (AMDD).
General Labeling Principle under the AMDD: The label found on the device should be a reasonable size for the type of device and should contain as much information as possible for the user to be able to identify and safely use the product. Depending on the size, additional information can be included inside the packaging, and/or on the Instructions for Use (IFU). IFUs may not be needed for all classifications of devices, such as low risk products.
All products must be labeled in English.
Product labeling is part of the review process and typically contains the following components:
- Product Owner Name, Address and Tel. No.
- Trade or Brand Name
- Details for identifying device
- Batch and Lot No.
- Expiration date (if applicable)
- Sterile or Non-Sterile
- Warnings regarding malfunctions, precautions, proper disposal
- Additional product and tech specific requirements, i.e. single use only, implantable devices, radiation emitting, custom made, non-clinical use, refurbished devices, devices using or administering medicine, etc.
IVD Specific Requirements
IVD products must adhere to additional requirements on top of the above outlined Medical Device guidelines.
IVD products will also need to include:
- Intended Purposes (type of analyte of the assay, qualitative vs. quantitative, etc.)
- Test principle
- Assay procedure, including calculation and interpretations
- Specimen type
- Performance characteristics
- Conditions for collections
- Reference Intervals
- Reagent description and any limitation
- Study design
Contact Asia Actual to see if our Singapore labeling solutions are right for your needs.
Singapore Regulatory Support
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