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

NhuTuyet

Starting to get Involved
#1
Hi everyone :bigwave:!

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 :thanks:.

Have a nice day.

NhuTuyet.
 
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Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#2
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.
 
M

Mondo 22

#4
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
 
G

Gachon

#5
>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.
 
C

cjr978

#6
>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.....
 
V

Vlcekad

#7
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!
 
Q

QARAM

#8
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?
 
M

MIREGMGR

#9
We have an ISO 13485 certificate, but some of the processes are subcontracted out.

As our subcontractors aren't medical device companies, they don't need to be certified to ISO 13485.
I think your COFEPRIS issue stems from a more fundamental issue. My understanding would be that any Contract Manufacturer listed on your ISO 13485 certificate should themselves have a certified quality system. Any company from which you buy materials or services that is not so certified is not qualified as a Contract Manufacturer, they should not be listed on your certificate, and you are responsible for their operations on your behalf as well as their outputs.

Similarly, any supplier that is notified to FDA as a Contract Manufacturer, as part of a Certificate to Foreign Government submission or otherwise, must be Registered and must List their device-products. If they are not Registered, they cannot be a Contract Manufacturer.

If your suppliers perform what should be regulated processes and your view is that they rather than you are responsible for those processes and their outputs, but your suppliers are not regulatorily compliant as demonstrated by their being appropriately Registered and certificated, your core regulatory stance may have a problem.
 
Q

QARAM

#10
The contract manufacturer is ISO 9001 certified, but Mexico isn't accepting that. Our own production quality assurance certificate issued by the notified body lists them as a significant subcontractor and our notified body has had no issues with them.

The FDA has told them that they don't want them listed because they don't manufacture finished goods. According to the FDA Establishment registration and listing, a manufacturer of components that are distributed only to a finished device manufacture does not need to register, list, or pay the fee (as far as my understanding goes).

I just don't know how to satisfy COFEPRIS.
 
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