International Laboratory Requirements — CLIA for Labs Outside the U.S.

CLIA follows the specimen, not the laboratory. If you're a lab outside the United States testing specimens collected in the U.S., CMS considers you subject to CLIA — and the state rules of the state where the specimen originated apply to you as well.

Federal agency

Centers for Medicare & Medicaid Services (CMS), Division of Laboratory Services (DLS) — the primary contact for international laboratories seeking CLIA certification. CMS defines an "international laboratory" as a facility outside the U.S. or its territories that performs laboratory tests referred by, and returns results to, a facility or authorized person in the U.S. or its territories.

When CLIA applies

Any testing of materials from human specimens collected in the United States and its territories is subject to CLIA regulations. If specimens are transported outside the U.S. for testing, the international laboratory performing that testing is subject to CLIA. Two important limits CMS states explicitly:

  • CLIA applies only to tests performed on specimens collected from the U.S. and its territories. If your lab runs many test types but only performs, say, molecular genetics on U.S. specimens, only that U.S.-specimen testing is subject to CLIA.
  • CMS notes that international laboratories may also be subject to additional state laboratory requirements.

How to apply

International laboratories seeking CLIA certification should contact CMS's Division of Laboratory Services before completing Form CMS-116 — the current MLN guidance directs international labs to email DCLIQSurveyBranch@cms.hhs.gov first. Certification is available through CMS-approved accreditation organizations, or by applying for the CLIA certificate level appropriate to the testing performed.

Forms

Application forms

Fees

CLIA is a user-fee program; certificate and survey fees apply. Check the current CMS fee schedule before applying.

Personnel requirements

CLIA personnel standards apply to the personnel performing the CLIA-regulated testing — the same qualification, responsibility, and competency requirements that apply to U.S. laboratories. State personnel rules (for example, New York's or California's individual personnel licensure) may also reach your staff depending on the specimen's state of origin.

Inspection

International laboratories are subject to CLIA survey requirements, or to inspection by a CMS-approved accreditation organization if certified through one. CMS coordinates international laboratory oversight through its central office rather than through state survey agencies.

Renewal and changes

CLIA certificates renew on their standard cycles; keep the certificate current and report changes (ownership, director, location, test menu) through the same channels U.S. laboratories use.

The state layer still applies

This is the point most international labs miss. CLIA is only the federal floor. Six states — California, Florida, Maryland, New York, Pennsylvania, and Rhode Island — require out-of-state (and out-of-country) laboratories to hold a state license or permit before testing specimens from their residents. A lab in London, Toronto, or Singapore testing California patient specimens needs a California license; the same specimen-origin logic applies in each of the other five states. Check the state pages in this hub for the state where your specimens originate.

How international testing differs from a U.S. lab

  • CLIA jurisdiction is triggered by the specimen's origin, not the lab's address.
  • Only the U.S.-specimen testing is CLIA-regulated; the rest of the lab's work is not.
  • Certification runs through CMS's central Division of Laboratory Services, not a state survey agency.
  • State licensure requirements follow the specimen into your lab — the state pages in this hub apply to you.

Official links

Last verified: October 2026