Whether CE is required for Pakistan MD registration

[Emma2010]

Hello Everybody,

For Chinese manufacturers, I would like to know if the medical devices must be previously approved in the CE market to be approved in Pakistan. Our Chinese partner has got their products approved in both their original country (China) and the FDA, but we received a query requiring the design examination certificate when we applied for registration in Pakistan.
Does anyone have any clue for such a query? Any comments will be highly appreciated!
Thanks a lot!

 

[helonmed]

Hello Everybody,

For Chinese manufacturers, I would like to know if the medical devices must be previously approved in the CE market to be approved in Pakistan. Our Chinese partner has got their products approved in both their original country (China) and the FDA, but we received a query requiring the design examination certificate when we applied for registration in Pakistan.
Does anyone have any clue for such a query? Any comments will be highly appreciated!
Thanks a lot!

Yes, CE certificate is required for Pakistan MD registration