Pakistan?s Drugs Regulatory Authority has issued new medical device and in vitro diagnostic (IVD) regulatory requirements, the Medical Devices Rules 2015, which have gone into effect.
The new regulations include requirements for conformity assessments, quality management systems, classification guidelines, authorized representation for foreign manufacturers and related registration steps. Publication of the new rules follows legislation established in late 2012 to formally regulate medical devices and pharmaceuticals in Pakistan. Refer the attachment.
See more at: http://www.raps.org/Regulatory-Focu...h.wDNJS3xe.mjjo#sthash.wDNJS3xe.ZClHYAgD.dpuf
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The new regulations include requirements for conformity assessments, quality management systems, classification guidelines, authorized representation for foreign manufacturers and related registration steps. Publication of the new rules follows legislation established in late 2012 to formally regulate medical devices and pharmaceuticals in Pakistan. Refer the attachment.
See more at: http://www.raps.org/Regulatory-Focu...h.wDNJS3xe.mjjo#sthash.wDNJS3xe.ZClHYAgD.dpuf
.