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New Medical Device and IVD Registration Rules - Pakistan

Ajit Basrur

Staff member
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.

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Hi Ajith,

I have gone through the Pakistan's new regulations and there is no mention of "who holds Registration/Enlistment Certificate in Pakistan"?

I really appreciate if you could help me with the answer.


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It is just the one rule, which cover IVD and rest requirements including pharma also.
If any specific help needed, do let me know i can check with authorities.
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