Estimated Timeline
10 - 25 Working Days
Applicable Standards
US FDA 21 CFR Part 820 (QSR), 21 CFR Part 11
Eligibility Criteria
Medical device, cosmetic, and food manufacturers exporting into the United States.
Mandatory Documents Required
Facility Details & US Agent Designation Letter
Product Classification & Device Listing Details
Step-by-Step Certification Process
1
Facility Establishment Registration on FDA FURLS
Handled end-to-end by DTLS India compliance managers, lab liaisons, and government desk officers.
2
US Agent Appointment
Handled end-to-end by DTLS India compliance managers, lab liaisons, and government desk officers.
3
Product Device Listing
Handled end-to-end by DTLS India compliance managers, lab liaisons, and government desk officers.
4
Issuance of FDA Registration Confirmation
Handled end-to-end by DTLS India compliance managers, lab liaisons, and government desk officers.
Related Compliance Schemes:
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