GMP certificates for manufacturing sites abroad: what ANMAT Disposition 6403/26 changes
On October 6, ANMAT, Argentina’s health authority, published Disposition 6403/2026in the Official Gazette. It sets out how Good Manufacturing Practice (GMP) certificates are issued for medical device and IVD sites located outside MERCOSUR. It does not replace the existing framework: it complements Disposition 7425/2013, with the stated aim of saving time and avoiding duplicated effort through collaboration, reliance and harmonization.
The essentials: the Argentine importer files the application, based on the site’s current ISO 13485 certificate (issued by an IAF/ILAC-accredited body) and a sworn statement. ANMAT’s initial review takes 40 business days and may end in the certificate, a request for information, a virtual assessment or an on-site inspection. Validity depends on risk, recertification is requested within 60 business days before expiry, and the certificate covers both new registrations and post-approval changes.
Why it matters: a single certificate model brings more predictability for international manufacturers. But because the review relies on ISO 13485, any mismatch between that certificate and the Argentine filing becomes an observation, and a delayed GMP certificate delays registration and launch. ANMAT may still request supporting documents such as the Site Master File or an apostilled manufacturing license.
Where filings get stuck: company name or address mismatches, product families outside the certificate scope, unclear roles across multiple sites (legal manufacturer, production site, sterilizer) and ISO certificates that expire mid-process.
Get the GMP checklist: comment “CHECKLIST” on this article or email info@lamaaccess.com with the subject “GMP Checklist” and we’ll send you our practical checklist (in Spanish; English version on request).
LAMA already has experience obtaining ANMAT approval for foreign manufacturing sites, many of them in Asia, including China. Planning to register products from a site outside MERCOSUR? Let’s talk.