Peru Medical Device Requirements


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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!

Belinda Lin

Medical Device RA
You can search for the regulations on DIGEMID's website if you know Spanish.
I have never read the regulations as I don't know Spanish. But according to my experiences in registration in Peru, any changes related to the information supplied by Manufacturer (e.g. label, IFU) and on the registration certificate should be notified to the DIGEMID. The change approval process will take quite long time.
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