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The threshold increase is precautionary

The packaging must also include the following information: The name and address of the manufacturer, packer, or distributor The trade or brand name of the device The unique device identifier (UDI) The intended use of the device The instructions for use Any warnings or precautions The expiry date (if applicable) The batch or lot number In addition to the labeling and packaging requirements, medical devices in Singapore must also comply with the following requirements: The device must be manufactured in accordance with Good Manufacturing Practices (GMP) The device must be subjected to appropriate clinical trials The device must be accompanied by a Declaration of Conformity (DoC) For more information on the labeling and packaging requirements for medical devices in Singapore, please refer to the following HSA guidance documents: Are clinical trials or testing necessary for registration of medical devices in Singapore

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