Typical timeline
1–2 months
One of the fastest documents in this database to obtain, assuming underlying domestic registration is already in place.
General / Export Documentation
Certificate of Free Sale
Export documentation confirming a product is legally sold in its country of origin — often required by importing countries.
Overview
What Free Sale Certificate is and why it matters
A Certificate of Free Sale (CFS) is an official document confirming that a product is legally manufactured and sold in its country of origin. Many importing countries require it, particularly where no mutual recognition agreement exists with the exporting country, as a condition of import registration.
Requirements
What you'll need
The documentation and evidence a complete submission is normally built from.
- Proof the product is legally marketed in the country of origin
- Product listing/registration in the country of origin (where applicable)
- Notarization or apostille legalization, depending on the destination country
- Typical validity period of 1–2 years
Planning ranges
Typical timeline and estimated cost
Ranges illustrate general market patterns for this pathway — they are not a quote for a specific product.
Estimated cost
$200–$2k
Low cost relative to other certifications — this is a documentation exercise, not a technical review.
Timelines and costs above are typical ranges illustrating general market patterns, not a quote or regulatory conclusion for your specific product. Actual figures depend on device classification, target country, and applicant readiness — professional review is required before relying on this for a business decision.
Where this applies
Applicable countries
Jurisdictions that recognise this certification. Scope and conditions still vary by product classification.
Issued by the country of origin; typically required by the importing country
Related
Regulatory Pathways
FAQ
Frequently asked questions
Do I need a new CFS for every export shipment?
No — a single valid CFS is typically reused across shipments and destination countries within its validity period, though some countries require it to be freshly notarized or legalized for their specific import process.
Reviewed packages
Buy a defined outcome
Pay for a market-access outcome — not a feature tour
Market Entry Sprint from $2,500 · Strategy Session $500 · Pathway Brief $1,800. Professional review required before business use. No patient data on public forms.
Reviewed launch planning
Need a Free Sale Certificate pathway brief?
Free Sale Certificate pathway briefs start at $1,800. Or book a $2,500 Market Entry Sprint that includes regulatory pathway outline, evidence flags, and a review call.
Professional review is required before business use.