New Medical Device and IVD Registration Rules - Pakistan

Ajit Basrur

Leader
Admin
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: https://www.raps.org/Regulatory-Foc...h.wDNJS3xe.mjjo#sthash.wDNJS3xe.ZClHYAgD.dpuf
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Attachments

  • Pakistan Med Device.pdf
    1.5 MB · Views: 698

Mallappa

Involved In Discussions
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.
 

Ajit Basrur

Leader
Admin
Hello Mallappa, welcome to the Cove :bigwave:

Sorry, I do not have answer to your question. Let us wait for Covers to respond.
 

Mallappa

Involved In Discussions
Hello everyone,

I am looking for the regulation/ guidance document which covers the registration of PCR test kit in Pakistan.

1. Do the new regulations in Pakistan covers both IVD and Medical devices or is there separate guidelines available?

I could not find separate regulations apart from this link (broken link removed)

Looking for your response.

Thank you in advance!
 

lynchoid

Registered
The regulations do cover MD and IVD, including classifications.
 

Attachments

  • FFSCHEDULEACLASSIFICATIONOFMEDICALDEVICES (1).pdf
    517 KB · Views: 195

WAQAR-QMS

Medical Devices Expert
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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