10166 W Flagler Street · Miami, FL 33174

2915 Biscayne Blvd, Suite 300-1 · Miami, FL 33137

Medical Device Export

Apostille Medical Device Export Documents — FDA, ISO 13485, CFG

Medical device manufacturers exporting to Latin America and other markets need apostilled FDA clearance letters, CFG certificates, and manufacturer authorization documents. We process all medical device export documents same-day in Miami.

Documents We Apostille

FDA 510(k) Clearance Letter (apostilled)
Certificate for Foreign Government (CFG) / Certificate to Foreign Government (apostilled)
Manufacturer Authorization Letter (notarized, apostilled)
ISO 13485 Certificate (notarized, apostilled)
CE Mark Certificate (notarized, apostilled)
FDA Establishment Registration (apostilled)
510(k) Summary (apostilled)
Quality Management System Certificate (notarized, apostilled)

Regulatory Markets We Serve

COFEPRIS (Mexico)

Mexico COFEPRIS requires apostilled FDA clearance letters, CFG certificates, and manufacturer authorization for medical device registration.

ANVISA (Brazil)

Brazil ANVISA requires apostilled FDA documents and ISO 13485 certificates for medical device registration and import.

INVIMA (Colombia)

Colombia INVIMA requires apostilled FDA clearance and manufacturer authorization for medical device market authorization.

DIGEMID (Peru)

Peru DIGEMID requires apostilled FDA documents for medical device registration and import authorization.

ISP (Chile)

Chile ISP requires apostilled FDA clearance letters and manufacturer authorization for medical device registration.

ANMAT (Argentina)

Argentina ANMAT requires apostilled FDA documents and ISO 13485 certificates for medical device registration.

Apostille Your Medical Device Documents

Same-day apostille for FDA and medical device export documents. Call or WhatsApp us.

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