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Newsletter – HK and Asia Regulatory - BSI America

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Convener ContactJack Wong<strong>Regulatory</strong> Forum in SingaporeA <strong>Regulatory</strong> training on GDP <strong>and</strong> forum was conducted inSingapore on 28-29 May 2009AHWP Hong KongrepresentativeEmail:jack.wong@bsigroup.comGDPMDS (Good Distribution Practices for Medical Devices) aimsto ensure product quality is maintained during storage <strong>and</strong>distribution. It acts as a st<strong>and</strong>ard to meet the above requirement<strong>and</strong> applies to storage practices such as Pest control, adequatestorage areas, appropriate storage conditions, good storagepractices (eg, EEFO – Earliest Expiry First Out) <strong>and</strong> properdocumentation <strong>and</strong> records.<strong>BSI</strong> Singapore is amongst one of the Certification Body that hasbeen awarded by Singapore Accredited Council (SAC) to providecertification for Good Distribution Practices for Medical Devices(GDPMDS).<strong>BSI</strong> Singapore office had successfully conducted “GDPMDSSharing Seminar” with many companies that are interested in theapplication for certification to join <strong>and</strong> share their feedback <strong>and</strong>experience.Any company that has activities of importing or does wholesale ofmedical devices <strong>and</strong> wishes to apply for the Import or Wholesalelicense is required by law (under the Health Products Act – in2007) needs to be certified to GDPMDS st<strong>and</strong>ard.

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