Compliance FAQ: The Ten Must-Answer Questions

The Ten Musts

1. Device paperwork? Registration + local registration (the entry).
2. Advertising bans? Efficacy promises, absolutes, comparisons (the no-go map).
3. Record retention? Charts 15-30 years class (the retention).
4. Inspections? Standard moves + truthful supply (the readiness).
5. Can beauticians operate devices? Boundary rules (the scope).
6. Insurance? Premises + professional liability baseline (the basics).
7. Before/afters? Authorization + authenticity + labeling (the entry).
8. Client data? Minimization + tiers + breach plans (the privacy).
9. Minors? Policy red lines with medical exceptions (the entry).
10. Influencer deals? Ad labeling + review rights (the entry).

More Top Questions

11. Cross-border device purchases — compliant? Yes when following the access path (the flow).
12. Client photos on our feed — infringement? Without authorization, yes (the entry).
13. Staff side-dealing? Contract clauses + evidence + graded response (the policy).
14. Unregistered imports usable? Not for clinical use (the access).

Self-Check Frequency

• Quarterly: the five checks (the checklist).
• Annually: external counsel/consultant review.
• Event-triggered: complaints, regulation updates, peer enforcement.

Related Terms

• CE-MDR
• 510(k)
• Counterfeits