Medical Device Registration in Pakistan

#1
Can anyone tell me how long it will take to register a class II or class III medical device in Pakistan? I'm aware of all the changes which are coming into force and have all the documentation ready to submit, just can't find anywhere how long it will take to complete once submitted.
 
Last edited:
Elsmar Forum Sponsor
M

MPiska

#2
I've not had any luck with contacting the DRAP regarding the registration process as there are a few questions I have on representation within country, I don't expect the requirements to be fully enforced later in the year based on the information available.

The one answer I got after the new regulations were published was "wait the 18 months transition period, there may be new bylaws introduced"

I'd be interested if you have any further information over and above the published regulation?
 

LFZR88

Involved In Discussions
#3
Hi,
we are just doing registrations through a distributor in Pakistan and he tells us it's 3 months+ to get registrations through for II & III's (but we shall see) there is a deadline of 30th June 2016 before the new regulations come into force that we are intending to hit with our submission, which at the moment seems fairly straightforward. (famous last words)

Can you tell me whether we can ship goods whilst waiting for the registrations to come through, our distributor is telling us we can, but I can't find anything to back this up, anyone have any knowledge on this?

Thanks
 
Last edited:

fialor

Involved In Discussions
#4
I am wondering if anyone was able to get an idea of registration times for Pakistan under the new regulations?
Thanks
 
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