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What regulatory licenses and certifications should I verify for a medical or wellness company?
Executive summary
When vetting a medical or wellness company you should check both mandatory government licences (professional licenses, facility/business registrations, FDA device registration, state device/distributor permits, DEA/controlled‑substance authorizations where applicable) and optional industry certifications (wellness coach, corporate wellness, NCQA program accreditation) that signal competence — but certifications are not substitutes for regulatory licenses (facility or professional) [1] [2] [3] [4]. State rules and scope-of-practice often drive what must be held on file (for example medical directors, supervision, or state-specific IV therapy rulings), so verify state boards and agency records, not only marketing claims [5] [6] [7].
1. Check clinicians’ professional licences — the core legal requirement
Confirm that physicians, nurses, physician assistants and other regulated clinicians hold active state professional licences with the issuing board (states’ licensure bureaux review qualifications and maintain public records) because medical services are typically regulated the same as other medical practices and clinicians must be properly credentialed [7] [5] [1].
2. Verify facility, business and establishment registrations
Even where a “medical spa” facility licence does not exist in name, businesses must still register at local and state levels (business registration, establishment licences, cosmetology or barbering establishment licences in some states) and hold the appropriate establishment licences for the services they provide — do not assume the absence of a “medspa” licence means no permits are required [5] [8] [9].
3. Confirm scope-of-practice and supervision rules for specific services
Some procedures (e.g., IV therapy, injectables, lasers) are treated as the practice of medicine or require physician oversight in many states; recent state board actions and guidance can restrict who may diagnose or perform treatments and what supervision is required, so check state medical/nursing board opinions and enforcement history for the relevant state [6] [10].
4. For products and devices: FDA registration plus state device/manufacturer licences
If the company manufactures, distributes or imports medical devices or radiation‑emitting equipment, federal establishment registration/listing with the FDA is required and many states impose separate manufacturer/distributor licences — state regimes vary widely and can attach to virtual distributors or third‑party logistics providers [2] [3] [11].
5. If drugs or controlled substances are involved: DEA and drug manufacturing/wholesale licences
Businesses that handle prescription drugs, compounding, or controlled substances must meet federal and state drug licensing rules (e.g., drug/manufacturer/wholesaler licences) and may also be subject to reporting and inspection regimes; drug licensing obligations differ from device rules and require separate checks [12] [3].
6. Check credentialing, accreditation and programmatic certifications — useful but not a legal shield
Industry certifications (Certified Wellness Practitioner, Certified Corporate Wellness Specialist, NCQA Wellness and Health Promotion accreditation, NBHWC‑approved training for health coaches) indicate training and adherence to standards and can help evaluate quality for non‑medical wellness services; however, there is no single legal requirement for many wellness certifications and they do not replace state professional licences or regulatory permits [13] [14] [15] [16] [4].
7. Confirm insurance, QA processes and equipment maintenance paperwork
Legal risk management for med‑spa and wellness providers includes documentation of treatment protocols, medical director agreements, equipment maintenance/calibration, incident reporting and adequate liability/medical malpractice insurance — these operational documents are frequently highlighted in compliance reviews and enforcement actions [10].
8. Don’t rely on marketing — use primary government records and board checks
Marketing claims about “board‑certified” staff or “licensed clinic” should be validated against state board databases and FDA establishment lists rather than third‑party directories. State licensing authorities and boards are the primary sources to resolve ownership, supervision and licensure questions [7] [2] [17].
9. Be attentive to cross‑jurisdiction complexity for national or digital services
Companies operating across states or offering digital health, SaMD, or telehealth face a mesh of federal, state and international rules (FDA device/drug rules, state telemedicine/board licensure, and evolving AI/device guidance). Expect different licensing requirements by state and additional obligations for digital products and AI components [18] [19] [20].
10. Practical checklist to verify, and where to look
- Search state medical, nursing and pharmacy board license lookups for clinicians [7].
- Confirm business/establishment licences and local health department permits [9] [8].
- Look up FDA establishment registration and device listings when devices are involved [2].
- Check state device/distributor/manufacturer licensing policies and pharmacy manufacturer lists if drugs/devices are distributed [11] [21].
- Review any claimed wellness certifications (CWP, CCWS, NBHWC programs, NCQA) for program rules and whether they are voluntary recognitions [13] [14] [16] [15].
Limitations and disagreements to note: reporting shows broad consensus that licences and state rules are the decisive obligations, while wellness certifications are helpful but optional — sources caution that state device and distribution rules are fragmented and enforcement varies, so a single national check is not sufficient [5] [4] [3]. Available sources do not mention a single universal list that applies to every U.S. state; you must check the specific state and federal registries for the company’s operations and services (not found in current reporting).