Certificate of Free Sale in Panama: The Multi-Country Rule

1. Key takeaways

Item 11 of Article 36 of Decreto Ejecutivo N° 490 requires a currently valid certificate of free sale (Certificado de Libre Venta) issued by the competent authority of the country of provenance (país de procedencia). Where more than one country of provenance exists, the certificates of all of those countries must be submitted. Products manufactured within the Republic of Panama are exempt from this item. The key to reading the provision correctly is to keep two concepts apart, country of origin (país de origen) and country of provenance (país de procedencia), which Panamanian law defines separately, and to remember that the certificate is issued by the country of provenance, not by the country of origin.

In practice this single distinction decides which authority a manufacturer has to approach. A device manufactured in one jurisdiction and placed on the market by a sales entity in another will need the certificate from the jurisdiction where the finished product is sold, and that is frequently not the manufacturing site. Because the provision also multiplies the requirement by the number of countries of provenance, a product supplied through several regional sales entities generates several certificates, each of which then has to pass through the legalisation route in Article 35.

• The certificate must be currently valid and issued by the competent authority of the country of provenance.
• Every country of provenance must produce its own certificate; one certificate for the group is not enough.
• Products manufactured in Panama are exempt from item 11.
• The certificate must state that the device is registered and that its sale for human use is lawfully authorised in that country.
• As a foreign legal document, the certificate is subject to apostille or consular legalisation under Article 35.

2. Legal basis

The requirement sits in item 11 of Article 36 of Decreto Ejecutivo N° 490 of 4 October 2019. Its operative terms depend on definitions spread across two instruments: Article 2 of Decreto Ejecutivo N° 490 and Article 6 of Ley N° 90 of 26 December 2017. Article 35 of the decree then governs how the foreign certificate is authenticated.

The two definitions work as a pair. Definition 34 looks backwards to the industrial act that gave the product its essential character. Definition 35 looks at the market where the finished product is sold and where the certifying authority sits. Article 36, item 11 attaches the documentary obligation to the second of the two.

3. Expert insights

Insight one: Panama defines country of origin and country of provenance separately, which is uncommon in Central American legislation. Definition 34 treats the country of origin as the place of the last substantial transformation or processing, while definition 35 treats the country of provenance as the country where the finished product is sold and which issues the certificate of free sale. Read with item 11, the two definitions produce a clear rule: the certificate of free sale follows the country of provenance, not the country of origin. Where a device is manufactured in China and the selling entity sits in the European Union, the certificate to be filed is the one issued by the competent authority of the European Union.

Insight two: the rule that multiple countries of provenance must each file is an underestimated cost item. Item 11 states that if more than one country of provenance exists, the certificate of free sale of all of the countries must be presented. For a company that supplies the same device through several regional sales entities, this means preparing several certificates for one product, each of which must then be apostilled or consularised. That is not a trivial line in either the project budget or the timetable, and it is the item most often discovered late, when the dossier is otherwise complete.

Insight three: the exemption covers only products manufactured within Panama. The exemption is worded as products manufactured in the Republic of Panama. Read together with Article 36-A, added by Decreto Ejecutivo N.º 416 for class A and B devices made by public institutions in Panama, it confirms that domestically manufactured devices follow a separate documentary chain. One qualification is worth flagging: Article 36-A covers only class A and B devices made by public institutions, and how the current text applies to devices manufactured in Panama by private parties is not comprehensively covered (practical estimate).

Insight four: the certificate of free sale is a foreign legal document and falls under the authentication rules of Article 35. Because it is issued by a foreign authority, the certificate must be apostilled under Article 35, in accordance with Ley No. 6 of 25 June 1990, or consularised where the issuing state is not a party to that convention. The point is confirmed indirectly by Decreto Ejecutivo No. 1689, which relaxed the deadline for filing this very document for COVID-related devices to 180 working days, an exception that only makes sense because the document normally has to travel through an authentication chain.

4. Practical recommendations

• Before filing, identify the country of provenance of the product, meaning the place where the finished product is sold, rather than the country of origin, and obtain the certificate from that country.
• Where supply runs through several countries of provenance, prepare one certificate per country and arrange authentication for each of them separately.
• Verify that each certificate is currently valid, taking account of the validity rules applied by the issuing authority.
• Check that the certificate states both elements required by definition 16, namely that the device is registered and that its sale is lawfully authorised; where either is missing, obtain a replacement certificate.
• Start the authentication step early instead of waiting until the rest of the dossier is complete, since apostille and consular queues run on their own timetable.
• Keep a country-by-country schedule listing issuing authority, certificate number, validity and authentication status, so that a query on one certificate does not require reopening the whole file.

5. Verification checklist

• □ Country of origin and country of provenance distinguished under definitions 34 and 35
• □ Number of countries of provenance confirmed and a certificate obtained for each
• □ Certificate states both registration and authorisation of sale
• □ Certificate currently valid
• □ Apostille or consular legalisation completed under Article 35
• □ Exemption confirmed where the product is manufactured in Panama
• □ Authentication of each certificate tracked separately where several countries are involved

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support for the Panamanian market. Our team manages Ministry of Health (MINSA) sanitary registration applications, prepares Spanish-language dossiers, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com

Regulatory information verified as of 29 October 2026.