* ANMAT classification model is rule-based and set forth in Mercosur Resolution No. 40 "Mercosur technical regulation of medical products".
**ANMAT requires Certificates of Free Sale from recognized countries - Australia, Canada, Japan, United States, European Union. If device does not have CFS from a recognized country, a Good Manufacturing Practices (GMP) certificate will be required, which is similar to ISO 13485 and QSR.
IMPORTANT NOTE: Risk management in compliance with ISO 14971 is required for all implants, intrauterine devices and blood bags.
MDRC assists medical device companies worldwide with registration, representation, quality system compliance and distribution in Argentina shown below.
Determining the proper classification for your medical device is critical to ensuring a smooth registration process. We have many years' experience with Argentina medical device classification.
Companies without an establishment in Argentina are required to appoint an Argentina Authorized Representative as an in-country representative and liaison with ANMAT. Having an independent firm control the registration for your device(s) is critical if you will not have a direct sales office in Argentina. We will help you find a reliable Argentina Authorized Representative.
Technical File provides proof that your product is safe and effective. MDRC will prepare your Technical File in accordance with ANMAT regulatory requirements. We will also advise you on device labeling requirements and IFU in accordance with Argentinian regulations.
Argentinian quality system requirements are very similar to US FDA 21 CFR Part 820. Our consultants will advise you on what modifications must be made to your existing quality system to prepare for the ANMAT quality system certification audit. MDRC is also available to conduct preassessment audits to ensure that you, or your major suppliers, are ready for the audits. Internal auditor training is also available.
While your registration is being finalized, our distribution specialists can help you find and evaluate Argentinian distributors. This will increase the chances of finding a partner who is qualified and able to effectively market your products in Argentina.
| Validity | 5 years |
| Language | Documents and Labeling must be in Spanish |
| Postmarket Surveillance | Must report adverse events and device recalls. Post market studies |
| Expected Time | Class I devices: 1-2 months. All other devices: Officially the review time is 180 days for all classes of devices, however, actual review time is around one year. |
* ANMAT classification model is rule-based and set forth in Mercosur Resolution No. 40 "Mercosur technical regulation of medical products".
**ANMAT requires Certificates of Free Sale from recognized countries - Australia, Canada, Japan, United States, European Union. If device does not have CFS from a recognized country, a Good Manufacturing Practices (GMP) certificate will be required, which is similar to ISO 13485 and QSR.
IMPORTANT NOTE: Risk management in compliance with ISO 14971 is required for all implants, intrauterine devices and blood bags.
MDRC assists medical device companies worldwide with registration, representation, quality system compliance and distribution in Argentina shown below.
Determining the proper classification for your medical device is critical to ensuring a smooth registration process. We have many years' experience with Argentina medical device classification.
Companies without an establishment in Argentina are required to appoint an Argentina Authorized Representative as an in-country representative and liaison with ANMAT. Having an independent firm control the registration for your device(s) is critical if you will not have a direct sales office in Argentina. We will help you find a reliable Argentina Authorized Representative.
Technical File provides proof that your product is safe and effective. MDRC will prepare your Technical File in accordance with ANMAT regulatory requirements. We will also advise you on device labeling requirements and IFU in accordance with Argentinian regulations.
Argentinian quality system requirements are very similar to US FDA 21 CFR Part 820. Our consultants will advise you on what modifications must be made to your existing quality system to prepare for the ANMAT quality system certification audit. MDRC is also available to conduct preassessment audits to ensure that you, or your major suppliers, are ready for the audits. Internal auditor training is also available.
While your registration is being finalized, our distribution specialists can help you find and evaluate Argentinian distributors. This will increase the chances of finding a partner who is qualified and able to effectively market your products in Argentina.
