Hello Arslan,
Here is what I know about Argentina:
ANMAT - Resolution 3802/2004 - For Class I devices, manufacturers must only provide the declaration of payment, manufacturer/importer identification information, and declaration of compliance with Mercosur legislation. All medical device labels must contain the product description, information on how the product should be stored, product expiration date (if applicable), and information about the importer, including the address of the importing company. As with the documents that must be submitted for product registration, all labels must be in Spanish.
If you do not have a local presence in Argentina, appoint a qualified importer to be your Argentina Registration Holder (ARH).The ARH will facilitate and hold your device registration and be involved in post-marketing surveillance and vigilance reporting activities.The ARH's name and address, as well as its Technical Director's name and license number, must appear on the product label.
The only document required is the CFG to document reference country approval. In addition to ANMAT requirement, must also register with TAD.
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D Michelle Williams
VP - Operations
United States
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Original Message:
Sent: 16-Apr-2024 12:09
From: Anonymous Member
Subject: Class I (Non sterile, Non Measuring) Medical Devices Manufacturer - ANMAT: the Argentinean Health Authority
This message was posted by a user wishing to remain anonymous
Hello RAPS,
What are requirements for Class I (Non sterile, Non Measuring) Medical Devices foreign manufacturer to send devices to Argentina as per ANMAT: the Argentinean Health Authority regulations?
Do we need REP in Argentina like EU REP?
Is distributor in Argentina enough to import and sell devices in Argentina?
Does distributor in Argentina, need to list, devices data in their database just like PARD and FDA listing database?
Our distributor is asking for free sale certificate authorized by a foreign Agent, such as the FDA? didn't understand what does it mean and why they are asking.
Would appreciate your assistance.
Thanks - Arslan