Frequently Asked Questions - Labelling of Medical Devices

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

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.
  Medical Device Authority (MDA),
Ministry of Health Malaysia,
Level 6, Prima 9, Prima Avenue II,
Block 3547, Persiaran APEC,
63000 Cyberjaya, Selangor, MALAYSIA

  +603 - 8230 0300
  +603 - 8230 0200 
  mdb@mda.gov.my

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  • Last Modified: 07 May 2021.
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