MDA Registration number & Labelling requirements with 3 years transition
August 30, 2018
Malaysia: The Medical Device Authority has decided for implementation of an additional 3 year transition period for establishments to meet the requirements of labelling in accordance with the Sixth Schedule of Medical Device Regulations 2012, commencing from 5th August 2018. The existing labelling shall be applied during the transition period and establishments shall take appropriate action within this transition period to meet the requirements of labelling in accordance with the Sixth Schedule.
The Sixth Schedule states that:
A registered medical device shall be labelled to include a statement to the effect that the medical device has been registered under the Act.
The label shall be appropriately located depending on a particular medical device and its intended use, in accordance with the international standard for medical device labelling as determined by the Authority.
Use of Bahasa Malaysia is required for home-used medical devices and subjected to the Authority’s discretion for other types of medical devices.
The local industry clarified that the above labelling requirements and also the Product registration approval number can be implemented within these 3 years transition.
MDA expects companies to submit the Labelling changes to MDA within the time frame.