Operations • Import • Post-Market

Import Readiness and Post-Market Obligations: Staying Compliant After Launch

Launch is not the finish line. Your import posture and post-market systems must remain aligned with your FDA record, labeling, and operational reality—especially when enforcement signals emerge.

Import and Post-Market Compliance

1) Import readiness: How detentions happen

Detentions and import holds frequently trace back to preventable mismatches: inaccurate registration/listing data, inconsistent labeling/claims, or missing documentation during screening. Import readiness is a governance discipline, not a one-time checklist.

Common Import Friction Triggers

  • Out-of-date establishment registration/listing
  • Labeling inconsistencies and uncontrolled claims
  • Supply chain roles unclear (Manufacturer vs. Shipper)
  • Inadequate response readiness for screening questions

Operational Controls that Help

  • Maintained FDA portfolio with documented updates
  • Controlled labeling set and distributor claim governance
  • Defined escalation path for import events
  • Clear ownership of responses and supporting evidence

2) Post-market obligations you must operationalize

Once on the market, you must be ready for complaints, reportability assessment, corrections/removals decision-making, and potential recalls. These activities should be integrated with your quality system processes and your FDA-facing data.

  • Complaint handling: Intake, evaluation, trending, and escalation.
  • eMDR readiness: Reportability triage and timely electronic submissions.
  • Corrections and removals: Documented decisions and notifications when applicable.
  • Recall readiness: Execution planning, communications control, and effectiveness checks.

How BRS LLC Supports Readiness

We maintain the FDA portfolio baseline and help coordinate regulatory actions when post-market events occur.

  • Ongoing Registration Governance: Keeping data current and controlled to avoid detentions.
  • Import Readiness Support: Pre-empting mismatches and building escalation playbooks.
  • Post-Market Support: eMDR triage and reporting support for foreign firms.
  • Recall Coordination: Documentation support and communication strategy during corrections.