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Related Topic Tags
ce mark and ce marking, class ii medical device, cofepris (mexico's medical device and ivd oversight), fast track medical device registration, medical device registration, medical devices (general), mexico
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Old 29th April 2012, 04:20 AM
NhuTuyet NhuTuyet is offline
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Please Help! Fast Track for Medical Devices Registration in Mexico that are already CE Marked

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.

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Old 29th April 2012, 04:28 AM
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Re: Fast Track for Medical Devices Registration in Mexico that are already CE Marked

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.

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Old 29th April 2012, 12:07 PM
NhuTuyet NhuTuyet is offline
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Re: Fast Track for Medical Devices Registration in Mexico that are already CE Marked

Hi,

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

Thank you for your remark .

Have a nice day.

NhuTuyet
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Old 30th April 2012, 08:59 AM
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Re: Fast Track for Medical Devices Registration in Mexico that are already CE Marked

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
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Old 2nd May 2012, 02:14 AM
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Re: Fast Track for Medical Devices Registration in Mexico that are already CE Marked

>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.
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Old 6th June 2012, 09:13 AM
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Re: Fast Track for Medical Devices Registration in Mexico that are already CE Marked

Quote:
In Reply to Parent Post by Gachon View Post

>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.....
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Old 20th January 2014, 01:58 AM
Vlcekad Vlcekad is offline
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Re: Fast Track for Medical Devices Registration in Mexico that are already CE Marked

Hi,

We are registering intraocular lens in Mexico through our distributor. The distributor is sayint that Cofepris will not accept our ISO 13485 certificate as a equivalent to GMP, because it is not written on the certificate it is a GMP (...). Distributor suggest that we ask our government to issue letter that would say, that our ISO 13485 certificate is for GMP.

Does anyone have any experience with Cofepris accepting ISO 13485 certificate?
Thanks!
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Old 31st January 2014, 11:00 AM
QARAM QARAM is offline
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Re: Fast Track for Medical Devices Registration in Mexico that are already CE Marked

I'm in the same sort of boat. We have an ISO 13485 certificate, but some of the processes are subcontracted out.

COFEPRIS wants ISO 13485 certificates for all our subcontractors or the Certificate of Good Manufacturing Practices.

As our subcontractors aren't medical device companies, they don't need to be certified to ISO 13485. The FDA doesn't want to visit them either because they aren't the finished device manufacturers. How do we get the Certificate of Good Manufacturing Practices?
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