Malaysia Update: Labeling, Exemptions, Advertising Rules
Medical device market regulators in Malaysia have recently issued new and updated rules regarding the planned transition to new labeling requirements, as well as clinical research exemptions and advertising rules for devices.
Transition period for labeling requirements
First, the Malaysian Medical Device Authority (MDA) is now proposing a two-year transition period for registrants to comply with new labeling rules detailed in the Sixth Schedule of the Medical Device Regulation 2012.
Following the two-year transition period, any manufacturer that “places any registered medical device in the (Malaysian) market…uses or operates any registered medical device to another person…or uses or operates any registered medical device to another person for the purpose of any investigational testing” will have to ensure compliance with new labeling requirements.
In the meantime, MDA registrants should manage their device labeling compliance according to existing rules.
Registration exemptions for clinical research
Second, the MDA has published new guidance on how medical devices intended for clinical research may qualify for exemption from Malaysian registration requirements.
According to the guidance, Malaysian regulators determine on a case-by-case basis whether to allow an unregistered device into the country for purposes of clinical research or performance evaluation. There are two notification types for which unregistered device may qualify:
- Notification for Investigational Device (ID), for conducting clinical investigations to determine the device’s safety and effectiveness
- Notification for device used for drug study, for clinical studies of drugs that involve medical devices (called non-investigational devices)
Both types of notification require submitting applications for MDA screening; investigational devices undergo “full board review,” whereas non-investigational devices go through “expedited review.” Full board reviews entail more involved regulatory involvement than expedited reviews.
The MDA guidance sets several conditions for obtaining exemptions for clinical research: Only sponsors are allowed to import unregistered devices into Malaysia; all responsibilities regarding quality, safety and performance of unregistered devices fall to sponsors; and sponsors must ensure that their clinical research and performance evaluation efforts comply with ISO 14155 for Good Clinical Practice. Companies should refer to the full MDA guidance for the full list of conditions.
Towards a “comprehensive” approach to medical device advertising
Finally, the MDA has issued an advisory note stating that the regulator is devising a “comprehensive guideline” for medical device advertising in the country.
Generally, only advertisements for devices registered for sale in Malaysia are allowed by the MDA; misleading or fraudulent claims pertaining to a device are also explicitly forbidden in the note.