Frequently Asked Questions - Labelling

• Yes, however, the labelling requirement need to follow the labelling requirement of the country of import.

• No

• Yes

• The establishment is given transition period of 6 months after medical device registration to include medical device registration number in its labelling.

• All labelling information has to be supplied with the medical device. If several medical devices are supplied in a box to a specific customer such as a healthcare facility for its consumption, the labelling may only be provided with the box. However, if for example, the medical devices are supplied in a box and supplied to a healthcare facility or a pharmacy so that it is to be sold or given to individual patient or customer, then labelling shall be provided with the individual medical device.

Yes. Refer definition below for home use medical device.

• A home use medical device is a medical device labelled for use in any environment outside a professional healthcare facility and intended for use by healthcare professionals and/or lay persons. This includes but is not limited to outdoor environments, office environments, schools, vehicles, emergency shelters, and independent living retirement homes.

Note 1: Lay person includes patient (care recipient), caregiver (includes non-healthcare professionals), or family member that directly uses the device or provides assistance in using the device.

Note 2: A home use medical device requires adequate labelling for the user and may require training for the user by a healthcare professional in order to be used safely and effectively.

Yes. Refer definition below for home use medical device.

• A home use medical device is a medical device labelled for use in any environment outside a professional healthcare facility and intended for use by healthcare professionals and/or lay persons. This includes but is not limited to outdoor environments, office environments, schools, vehicles, emergency shelters, and independent living retirement homes.
• Note 1: Lay person includes patient (care recipient), caregiver (includes non-healthcare professionals), or family member that directly uses the device or provides assistance in using the device.
• Note 2: A home use medical device requires adequate labelling for the user and may require training for the user by a healthcare professional in order to be used safely and effectively.

• These information shall be available on the outer box/external packaging. The manufacturer /AR may decide whether or not to include these information again in the IFU.

• The labelling is part of activity by the manufacturer. For AR that does additional labelling to comply requirements of MDA/GD/0026 shall get approval for labelling from manufacturer.