Malaysia Health Authority to Require Approval of Medical Device Advertisements, Impose Fees

Medical device manufacturers will require the approval of Malaysia’s Medical Device Authority before they can advertise their products in the country, under a new regulation going into effect July 1. Under the regulation, applications must include a copy of the proposed advertisement, a letter certifying the medical device is legally registered for use in the country, and a processing fee of 1,000 Malaysian Ringgit (about $245 US dollars). Advertisements must clearly display the registration number of the device. The regulation pertains to all advertisements for medical devices, whether in print or broadcast. The regulation has been under consideration since last year, but the particulars of the new requirements were made public in January.