>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.
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.