Verified October 10, 2026 against the statutes, regulations and sources cited below. The state decides every application. All states
What testing sites miss in Maine
- A Maine license lasts three years, longer than the two-year CLIA certificate, so the two renewals fall on different schedules.
- Labs incorporated for the shared use of physician owners lose the physician exemption and must be licensed.
Does Maine require a state lab license on top of CLIA?
Maine licenses every nonexempt medical laboratory. A lab running only CLIA-waived tests receives a limited license for the waived tests its supervisor is qualified to oversee. Pharmacies, med spas and other sites outside the exemptions need a license even for waived testing.
- Medical laboratory license (limited license for waived-only labs)
- Issued by Maine Department of Health and Human Services, Division of Licensing and Regulatory Services
- Reaches labs doing only waived tests
Citation: 22 M.R.S. 2013-A, 2015, 2017; 10-144 C.M.R. ch. 256
Who is exempt in Maine?
Physicians, physician associates, family nurse practitioners, Medicare-certified rural health clinics and group practices testing only their own patients within their CLIA certificate; school and workplace labs run by a physician, PA or NP for students or employees; hospital, government, research and permitted health screening sites.
Citation: 22 M.R.S. 2013-A(1); 10-144 C.M.R. ch. 256, sec. 3.6
What does Maine charge?
License application: $500 for the first testing category plus $60 for each additional category. Renewal: $200 plus $60 per additional category (as of October 2026). A health screening permit costs $100, lasts 24 months and is not renewable.
Citation: 22 M.R.S. 2017; 10-144 C.M.R. ch. 256, sec. 5
How often does a Maine lab registration renew?
- Due A license runs three years; the renewal form and fee are due at least 30 days before expiration
Do labs in other states need a Maine license to test its specimens?
The Act applies to labs operating in Maine; licensed Maine labs may refer specimens out of state if the report names the out-of-state lab. No Maine license for out-of-state labs was found.
Citation: 22 M.R.S. 2013-A, 2015
Where does a Maine CMS-116 go?
- Maine CLIA Program, Division of Licensing and Regulatory Services
- Email: CliaLab.DHHS@maine.gov
- Phone: (207) 287-9339
Opening a testing site in Maine?
We prepare the CMS-116 and any Maine filing for your owner or director to sign, and track both to approval. You pay CMS and the state directly. A Certificate of Waiver application is $399 per site.