Chile Certificate of Free Sale: The Four Elements Required by Article 21

1. Key takeaways

Article 21 of DS 825/1998 requires that imported devices be accompanied by a certificate issued in the country of origin for export purposes, authorized by that country’s competent authority, and duly legalized (debidamente legalizado) — in practice, the certificate of free sale (CFS). GRZAN breaks the requirement into four actionable elements:

1. The issuing body must be the competent authority (for example China’s NMPA, the United States FDA, or the competent authorities of the European Union);
2. the authentication method is an apostille or consular legalization;
3. a Spanish translation must accompany the certificate;
4. the product information must be identical word for word (name, model, manufacturer name, registration and listing numbers).

The fourth element produces the highest deficiency rate, and it is the only one determined entirely by the company’s internal processes. The other three are obtained once from external bodies; the fourth is re-verified on every document, every revision and every new SKU, which is why it deserves a controlled process of its own. In GRZAN’s project reviews, the CFS is checked against the submission file line by line before it ever reaches the issuing authority, because correcting a certificate after issuance means starting the document cycle again.

2. Legal basis

• Regulation on the control of medical products and devices | Decreto Supremo N° 825, de 1998 | 21 August 1999 | Article 21: imported products must be accompanied by a certificate issued in the country of origin for export purposes, authorized by the corresponding national authority of that country, and duly legalized.
• Same instrument | Article 21 | basic documentation requirements for Class I devices (identification information, materials declaration, sterilization and storage information, quality and production evidence, performance evaluation, and the certificate of origin-country export for imported products).
• Same instrument | item 13 of Article 2 | definition of the manufacturer (the entity that commercializes the product under its own name).
• ISP procedure | prestación 9100003 (v3, 25 September 2025) | the CFS or export certificate must be authenticated or apostilled.

3. Expert insights

Insight 1: the CFS certifies lawful marketability in the country of origin — not product quality.

The statutory wording is a certificate issued in the country of origin for export purposes. It proves a market-access status, not a quality status. Quality evidence is carried by ISO 13485, test reports and the performance evaluation. Confusing the two leads to a misaligned file structure: companies answer quality questions with the CFS, or try to replace the CFS with test reports. Neither substitution works, and both produce deficiency notices that a clear file architecture would have prevented. Assign each document its evidentiary role at the file-design stage, and the review queries will find each question already answered by the document built for it.

Insight 2: duly legalized is a formal requirement — missing it is an automatic deficiency.

Article 21 states the words debidamente legalizado in the text. Chile is a party to the Hague apostille convention, so most countries of origin use an apostille, and non-party states use consular legalization. There is no discretion on this element: an unauthenticated certificate simply does not satisfy the article. Check the authentication status of the CFS the day it arrives, not on submission day. The same check applies to every other authenticated document in the file, because the review examines the chain as a whole and one missing authentication contaminates the credibility of the rest.

Insight 3: the CFS is a time-limited document — plan backwards from the submission date.

A CFS usually carries a validity period or issuance-date limitation (practical estimate; follow the rules of the issuing authority). Placing it at the end of the documentation timeline produces the situation where the file is complete but the CFS has expired. GRZAN schedules backwards from the expected submission date and places CFS issuance inside a safe window immediately before submission, so the document is fresh at filing and still valid through the review.

Insight 4: the CFS product scope must cover the submission unit.

If the submission is a system — for example a blood glucose monitoring system containing the meter, test strips, lancets and control solution — the product scope stated on the CFS must cover all components, or separate certificates must be issued for each. A scope mismatch is a high-frequency deficiency item for IVD submissions, and it is far cheaper to fix at the issuing authority before submission than during a review. Define the submission unit early, list its components, and check the certificate wording against that list before the certificate is even ordered from the authority.

4. Practical recommendations

1. Run a CFS self-check against the four elements: issuing body, authentication method, Spanish translation and word-for-word consistency, ticking each item.
2. Apply the product master data to the CFS: name, model, manufacturer name and address, and registration and listing numbers must match the submission file exactly.
3. Schedule the issuance window backwards from the submission date so the CFS does not expire during review.
4. Make system-type products’ CFS cover every component, or issue separate certificates per component with cross-references.
5. Keep the issuing authority’s contact details and the issuance receipt to respond quickly if the ISP seeks verification.

5. Verification checklist

• □ The CFS has been confirmed as issued by the competent authority of the country of origin
• □ The apostille or consular legalization has been completed
• □ A Spanish translation has been attached and checked against the source text
• □ Product information on the CFS has been checked word for word against the submission file and labels
• □ The CFS product scope has been confirmed as covering every component of the submission unit

Regulatory information verified as of 29 October 2026.

GRZAN supports manufacturers entering the Chilean market with ISP registration pathways and classification strategy, including CFS planning, authentication scheduling and submission-unit scope checks. For a feasibility assessment of your specific product, contact the GRZAN regulatory team at info@grzanglobal.com.