Medical Device Registration in Pakistan

G

GCF21

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 by a moderator:
M

MPiska

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?
 
L

LFZR88

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:
F

fialor

Involved In Discussions
I am wondering if anyone was able to get an idea of registration times for Pakistan under the new regulations?
Thanks
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
K Question on registration of class 1 medical device in Turkey Other Medical Device Regulations World-Wide 0
S Mexico medical device registration - for demo Other Medical Device Regulations World-Wide 2
K Class I Medical Device Registration EU Medical Device Regulations 11
Aliken Registration veterinary medical device (laser) requirements Medical Device and FDA Regulations and Standards News 2
B Registration of a CE-marked medical device in Japan -Will they accept conformity with GSPRs? Japan Medical Device Regulations 0
C Medical Device registration CE Marking (Conformité Européene) / CB Scheme 3
T Medical Device Registration in Saudi Arabia Other Medical Device Regulations World-Wide 2
C Does a medical device active (zinc oxide) needs BPR registration in EU? Other ISO and International Standards and European Regulations 6
H Medical device Product Registration Registrars and Notified Bodies 2
S Registration of Medical Device in Hong Kong - labeling requirements Other Medical Device Regulations World-Wide 1
L Medical device registration in Iran Other Medical Device Regulations World-Wide 0
S Medical Device Registration in Qatar Other Medical Device Regulations World-Wide 3
L Medical Device Registration in Macau Other US Medical Device Regulations 1
Al Rosen Medical Device Registration in the Dominican Republic Other Medical Device Regulations World-Wide 11
M Medical Device Registration In Malaysia Other Medical Device Regulations World-Wide 4
N Adding unclassified product to the medical device registration US Food and Drug Administration (FDA) 1
Y Possibility for Medical Device registration in Israel Regulation Other Medical Device Regulations World-Wide 6
S Iraq Medical Device registration Other Medical Device Regulations World-Wide 0
J Medical Device Registration in the UAE MoH Other Medical Device Regulations World-Wide 2
M Mexico Medical Device Registration Requirements Other Medical Device Regulations World-Wide 2
JoCam False information provided for Medical Device Registration - What are the implications? Other Medical Device Related Standards 3
N Post registration variation to medical device Other Medical Device Regulations World-Wide 1
MDD_QNA Medical Device registration Argentina Other Medical Device Regulations World-Wide 0
R Medical device registration in Iran Other Medical Device Regulations World-Wide 1
G Device Registration Ammendments - Modifications to Medical Devices Other Medical Device Regulations World-Wide 4
J Medical Device Registration in Argentina - Client asks us to provide “European FSC” Other Medical Device Regulations World-Wide 4
A Philippines Medical Device Registration Transfer Other Medical Device Regulations World-Wide 1
A Docs for Medical Device registration in China - List of certificates China Medical Device Regulations 6
S Uzbekistan - Medical Device Registration Other Medical Device Regulations World-Wide 1
L Medical device registration in African/Asian countries Other Medical Device Regulations World-Wide 11
S FEE Registration LINK - EU Medical Device CE Marking (Conformité Européene) / CB Scheme 6
P Adding an additional distributor to a current Mexico Medical Device Registration Other Medical Device Regulations World-Wide 0
S Medical Device Registration & Technical Format/Template - European Union CE Marking (Conformité Européene) / CB Scheme 8
F IVD/Medical Device Registration (with MHRA DORS account in the UK) EU Medical Device Regulations 3
A Russia- Medical device with drug registration Other Medical Device Regulations World-Wide 0
3 Egypt Medical Device Registration: Only required for Sterile Medical Devices? Other Medical Device Regulations World-Wide 10
S Australian Registration of Non-CE Marked Medical Device CE Marking (Conformité Européene) / CB Scheme 2
Q Medical Device Establishment Registration/Listing for Foreign Private Labeler Other US Medical Device Regulations 8
P UDI Registration - Class II Medical Device Software Other US Medical Device Regulations 11
B Strategy for Registration a Medical Device in China China Medical Device Regulations 2
3 Medical Device Registration Phillippines Other Medical Device Regulations World-Wide 4
Q RFID (radio frequency identification) registration for Medical Device Other Medical Device Regulations World-Wide 6
G Design Philosophy - Iran Medical Device Registration Other Medical Device Regulations World-Wide 7
Q South Africa Class I Medical Device Accessory Registration Other Medical Device Regulations World-Wide 1
F Local Medical Device distributor registration UAE Other Medical Device Regulations World-Wide 1
K Medical device registration in Brunei Other Medical Device Regulations World-Wide 2
N Malaysian Medical Device Registration Requirements Other Medical Device Regulations World-Wide 8
I FDA Medical Device Registration - Scenario - Two Companies 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
R Medical Device Registration and Listing Help 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
Ajit Basrur New Medical Device and IVD Registration Rules - Pakistan Other Medical Device Regulations World-Wide 5

Similar threads

Top Bottom