Malaysia: MDA Invites for Public Feedback on draft of First Edition Guidance Importation of Medical Device for Personal Use

Medical Device Authority (MDA) has released a draft guidance document titled ‘Importation of Medical Device for Personal Use’ for public review and feedback. The guidance document will be applicable to all home use medical devices that fall within the definition of a medical device, as defined in MDA/GD/0006: Definition of Medical Device, including in vitro diagnostic (IVD) medical devices. The primary objective of this document is to provide comprehensive guidelines on the importation of medical devices to Malaysia for personal use as defined in the Medical Device (Exemption) Order 2016.

Details on the announcement could be accessed here; and to access the draft guidance document, please click here.

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