Medical Device Regulatory Consultant in Mexico

C

cjr978

Hi there, I am looking to find a reliable consultant to submit our medical device registrations in Mexico. I know the requirements for submissions but need someone local to acutally submit and hold the registrations.

I gather Emergo and Arazy group are the big players in the industry but does anyone have experience of them? Equally does anyone have recommended suggestions?

thanks
 

yodon

Leader
Super Moderator
I've worked with Emergo before. Good experience. (Client) Didn't register with Mexico but got through Canada and CE Marking for the EU. Client was a small company and Emergo developed the SOPs and acted as AR for EU. Had to rein in the SOPs to adapt for a small company but they were open to the adaptations. Again, overall good experience.
 
M

Mondo 22

I agree with Yodon, you wont go wrong using Emergo. (I have only used them as a Client)

Using someone like Emergo will enable you to change distributors easily.

Hope this helps
 
C

chw0705

Dear cjr978
Do you have delegated Emergo or others to register your product?

How do you think about the kind of service agency?

Looking forward to your reply. Thank u
 
Top Bottom