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 labeling in English.
Product labeling is part of the review process and typically contains the following components:
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.)
Assay procedure, including calculation and interpretations
Conditions for collections
Reagent description and any limitation
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