INFOHaem™ MSS FH1536™ Medical Regulatory Compliance


INFOVALLEY® Molecular Screening Services is registered under Malaysia's Ministry of Health’s Medical Device Bureau’s MeDVER programme (Registration number: A-000531).


About Medical Device Bereau (MDB)

To protect the public health and safety, the MDB strives to ensure that medical devices in Malaysia are of high quality, effective and safe.  In doing this, MDB play an important role and contribute to the quality of the healthcare system in the country.  Scrutinising and thoroughly assessing medical devices involves identifying new risks and rapidly taking safety measures.  MDB inform medical professionals and the consumers, the patients, about specific issues and new discoveries in the medical device sector. MDB core competent includes :
       -  registering medical devices (all classes)
       -  issuing licences to manufacturer, distributor, importer, exporter, 
       -  inspecting facilities (establishments)
       -  monitoring medical devices already on the market
       -  monitoring operation and usage of medical devices, including disposal
       -  (laboratory testing)
       -  drafting laws and standards

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