Changes to Medical Device Regulations in Argentina in Effect

ANMAT, the Argentinean medical device market regulator, has enacted a new interpretation of the General Law for Medical Devices (document in Spanish) that will affect various components of the country’s device registration process. Specifically, ANMAT Provision 5627-2006 has been replaced by ANMAT Provision 727-2013.

Apart from specifying requirements for renewals and modifications, as well as simplification of Class I dossiers, three of the most significant changes will affect Class II, III and IV device approvals:

  • Under Evidence of Commercialization requirements, applicants must provide histories of their commercialization in all countries where their devices are sold. This information should also include dates of market entry, as well as all recall, adverse event and corrective action issues involving their devices worldwide.
  • A Letter from the Manufacturer must be provided to a foreign manufacturer’s Argentina market importer attesting that the importer will be informed of all recall and safety field actions involving the manufacturer’s device.
  • Foreign manufacturers may now submit a Certificate of Free Sale (CFS) or Country of Origin Approval from any country to ANMAT. However, whether or not ANMAT accepts at CFS will be determined based on how similar the issuing agency’s regulatory actions post-market surveillance activities are to those of the Argentinean regulator.  The new requirements do not include a list of reference countries, but valid registrations in markets such as the US, Europe, Canada, Japan and Australia will likely be acceptable to ANMAT.

Overall, these changes are expected to result in a clearer medical device registration process in Argentina—not necessarily a faster one. 

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