Malaysian advertising rules for medical devices published

By Stewart Eisenhart, Emergo Group

The Malaysian Medical Device Authority (MDA) has issued draft requirements for how to properly market and advertise medical devices in the country.

The MDA draft code of advertising covers a broad array of advertising media, from physical signage to consumer brochures and commercials to “aerial promotion such as hot air balloon.” Malaysian regulators explicitly exclude any pricing, commercial policies or non-promotional communications from the new code.

Medical device advertisements must not make any claims that deviate from a registered device’s intended purpose or target patient group, according to the code.  Device advertisements must furthermore provide “reliable, accurate, truthful, informative, fair, objective, unambiguous, balanced, up-to-date” information, the MDA (thoroughly) states.

The code identifies manufacturers or Malaysia Authorized Representatives as “responsible persons” for device advertisements, although these parties are allowed to enlist outside firms to develop advertisements on their behalf.

The code also contains requirements regarding celebrity and healthcare provider endorsements, patient testimonials, therapeutic claims, comparative advertising and avoiding induction of “unwarranted anxiety” in consumers.

Medical device manufacturers with products registered for sale in Malaysia should familiarize themselves with these draft requirements to ensure any current or future advertising campaigns they’re running comply with the MDA code.

Stewart Eisenhart covers medical device regulatory affairs for Emergo Group.

The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees.

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