Hello Richard,
You are correct, there is no express regulation currently in place that specifically addresses eIFU in Peru. However, the local authority would accept IFU in "electronic" forma (aka CD-rom) as long as this is declared in the registration dossier; QR codes are not currently accepted.
Anon,
Regulations in Latin America are yet to evolve with the times, but most would accept the CD-rom alternative if disclosed during the registration process. However, a paper version has to be filed along with the registration dossier, and similarly to the EU, a paper version must be made available if a customer requests it.
Good luck!
Claudia Navarro
CEO & Cofounder
SaniLex LLC
We help MedTed Companies navigate the complex yet exciting Latin American Market
support@sanilex.com
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Claudia Navarro
Miami FL
United States
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Original Message:
Sent: 21-Apr-2023 09:25
From: Richard Vincins
Subject: Peru - Electronic IFU Acceptance
Hello Anon,
As far as I know there is no regulation in Peru for managing or controlling electronic Instructions for Use (eIFU). There is nothing which prohibits this from being done, but there is nothing which permits it being done. In fact, this is quite common for countries which do not have a well established regulatory process. There are only a small amount of countries which have any requirements, regulations, or guidance concerning eIFUs. The advice would be if establishing an eIFU for products distributed/sold in Peru, make sure this is all clearly documented in your quality system. Other regulations and guidance can be used as a model for how this could be performed. Document in the technical information related to your product decisions, rationale, content of labels, access to eIFU, and maintenance of the IFU/eIFU.
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Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
Original Message:
Sent: 20-Apr-2023 12:47
From: Anonymous Member
Subject: Peru - Electronic IFU Acceptance
This message was posted by a user wishing to remain anonymous
Does anyone know if Peru accepts electronic IFU, or if there are any regulations pertaining to this?
I have not been able to confirm any information regarding this topic with regulatory officials in Peru or with contacts.
Thank you!