By July 2014, almost all medical devices sold in Malaysia will require registration. In addition, all legal representatives of foreign medical device companies must have establishment licenses and certificates for Good Distribution Practices (GDPMD). Under the Medical Device Act 2012, those who fail to register by November 2014 will face significant fines and possibly jail time.
Registration can be done by a medical device manufacturer’s subsidiary office in Malaysia, a medical device manufacture’s Malaysian distributor or an independent license holder. For a third party to be approved as a legal agent by the Malaysian Ministry of Health, it must have an office in Malaysia and an establishment license. An establishment license can be obtained upon successful certification by one of Malaysia’s registered conformity assessment bodies (CAB).
An independent third party will also need to make sure it obtains a GDPMD certification by July 1, 2014. New good distribution practices guidelines released in July 2013 make it mandatory for third parties to comply with new standards for medical device procurement, delivery, storage, installation, calibration, tracking and other medical device supply-chain activities.
Pacific Bridge Medical is now offering all of these services in Malaysia. PBM can start medical device product registrations now and act as an independent license holder as soon as the devices are registered.