HSA Singapore Medical Device Labeling
Medical device labeling requirements in Singapore are enforced by the Health Sciences Authority (HSA).
Medical device labeling requirements in Singapore
Medical device labeling requirements in Singapore are informed by regulations enforced by the Health Sciences Authority (HSA), Singapore’s medical device regulator, as well as requirements in the ASEAN Medical Device Directive (AMDD). All labeling must be supplied in English. As part of your registration dossier, HSA will review your sample device labels for the device itself and its packaging, Instructions for Use (IFU), training materials, manuals, installation instructions, and any other information provided with the device.
As stated in HSA medical device labeling guidance, GN-23: Guidance on Labelling for Medical Devices, the medical device label should include information necessary to use the device safely. Whenever possible, this information should be printed or affixed to the device itself. However, HSA allows for essential label information to appear on packaging for a device unit, the outer packaging of multiple devices, or the IFU, if necessary. The information should be presented in a way that is suitable for the intended use of the device. The use of internationally recognized symbols is strongly encouraged. All labels must also include a Unique Device Identifier (UDI) that complies with HSA’s guidance on the UDI system.
Labeling information requirements in Singapore
In general, your medical device labeling should include the following information:
- Name and contact details of the Product Owner
- The trade or brand name of the medical device
- Information for the user to identify the device
- UDI
- Intended purpose and intended user
- Batch code, lot number, or serial number
- Expiration date, if applicable
- Sterile or Non-Sterile
- Storage and handling instructions
- Operating instructions
- Contra-indications, warnings, restrictions or precautions that may apply in relation to the use of the medical device
Additional labeling requirements apply to devices that are provided sterile, non-sterile, reusable, or custom-made; intended to incorporate or administer a medicinal or biological substance; implantable, emit radiation, IVDs; and more.
E-labeling and IFU requirements for medical devices in Singapore
Instructions for Use (IFU) is a leaflet, manual, or packaging insert that provides additional information about a medical device, such as the device’s intended purpose, proper use, and any precautions. While IFU is a general requirement, it may not be needed for devices that are low or moderate risk. In some cases, HSA allows the manufacturer to provide IFU in electronic format (i.e., e-labeling), such as for software or devices not intended for use by the general public. However, if e-labeling formats are used, the manufacturer must ensure the user has ready access to the correct version of the IFU and make paper copies available on request.
Frequently
Asked Questions
What is UDI?
According to HSA guidance on labeling, Unique Device Identifer (UDI) is “a series of numeric or alphanumeric characters that is created through a globally accepted device identification and coding standard. It allows the unambiguous identification of a specific medical device on the market.”
UDI has become a requirement for medical devices in markets worldwide in order to trace devices throughout the lifecycle for improved safety, with specific implications for postmarket surveillance, vigilance, withdrawals and recalls, etc.
Does HSA enforce specific labeling requirements for IVDs?
Yes. IVD manufacturers should refer to the labeling guidance for specific details about labeling requirements for IVDs. In general, the labeling should indicate that the product is an IVD along with the following information:
- intended purpose
- type of analyte or measurement of the assay
- whether the test is quantitative or qualitative
- clinical application of the test (e.g., screening, diagnostic or detection, aid to diagnostic, monitoring)
- the disorder, condition or risk factor of interest that it is intended to detect, define or differentiate
- type of specimen to be used (e.g., serum, tissue, blood, etc.)
- patient population
- intended users
Are medical device advertising and marketing materials regulated by HSA?
Advertising and marketing materials (such as brochures, etc.) do not need to be approved by HSA prior to distribution or publication. However, advertising materials must comply with Part V of the Health Products Act (HPA) and other HSA regulations. For more information about advertising requirements, refer to GN-08: Guidance on Medical Device Advertisements and Sales Promotion.
