Fast Track for Medical Devices Registration in Mexico that are already CE Marked

[NhuTuyet]

Hi everyone !

I need your advice please.

Do you know if there is a fast track in Mexico for medical devices that are already CE marked (class IIb)?

If this fast track does exist, how does it work?

Thanks for your help .

Have a nice day.

NhuTuyet.

[Marc]

Just to verify, you do mean CE Marked rather the EC Marked? This is not my field and so I can't personally help, but wanted to clarify.

[NhuTuyet]

Hi,

You are right! I meant CE marking but I misspelled it.

Thank you for your remark .

Have a nice day.

NhuTuyet

[Mondo 22]

Hi NhuTuyet,

Not that I am aware of but if your product is registered in Canada or 510(k)/PMA
COFEPRIS recognises this and an abbreviated registration route is followed.

I think recently, COFEPRIS now recognize products registered in Japan, although you would need to double check this.

Hope this helps.
Ray

[Gachon]

>I think recently, COFEPRIS now recognize products registered in Japan, although you would need to double check this.

Yes, you are right.
If your medical device is either approved or certified in Japan, then you can apply its registration with COFEPRIS based on the documents you prepared for its approval or certification. Spanish translation is indispensable, though.
And you cannot do so for the lowest class medical devices in terms of risk, because they are not either approved or certified.

[cjr978]

In Reply to Parent Post by Gachon

>I think recently, COFEPRIS now recognize products registered in Japan, although you would need to double check this.

Yes, you are right.
If your medical device is either approved or certified in Japan, then you can apply its registration with COFEPRIS based on the documents you prepared for its approval or certification. Spanish translation is indispensable, though.
And you cannot do so for the lowest class medical devices in terms of risk, because they are not either approved or certified.

I think Canadian registrations can also be used in the same way.

I realize no one has commented on this for a while but have a question if anyone can help

I am finding my fast track submissions taking advantage of their FDA 510(k) clearances are taking much longer than the official timeline of 3 months. To date some of them of them are approaching 9 months. If it in keeping with anyones experience or is there something strange happening?

To help anyone with no experience in mexico I can add to the general experience as well - reviewers take what seems like diferent opinions over the exact requirements. I found the hard way for instance that some want a copy of the establishment inspection report (which is often time consuming to get from the FDA) whereas others will accept the 482 notification as evidence of an inspection by the FDA.....