Peru Medical Device Requirements

jiligan

Involved In Discussions
Hello,

We have been working with our distributor for registration in Peru. Our distributor states that "any change introduced in a product duly registered shall be notified to the regulatory agency". We would like clarification on "any change" does this mean "all changes"? What changes exactly need to be notified, is there a regulation that goes into detail of the changes to be notified? In most countries I feel it is only significant changes, not any change. Thank you!
 
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