Certificate of Free Sale Multi-Country Issuance under the 2024 Amendment

1. Key takeaways

Article 1 of the 2024 amending decree (internal reference MS-AJ-CB-200-2024) rewrites definition 4.7 of the main regulation (Certificado de Libre Venta). After the amendment, the authorities that may issue the CLV expand from the competent authority of the country or territory of origin to four categories: the competent authority of the country or territory of origin; the competent authority of the country where the product holder is established; the competent authority of the country where the holder’s subsidiary is established; and the competent authority of the country where the subsidiary of the parent company is established (both belonging to the same parent company). The precondition is third-party manufacturing or subsidiary manufacturing where the product is not sold in the country of manufacture, and the subsidiary must be legally incorporated in the issuing country. The amendment directly resolves the long-standing deadlock of certificates refused because the product is not sold in the country of manufacture.

• Before the amendment, only two issuing authorities were available; after it, four.
• The three new routes all revolve around the holder and the corporate group structure.
• The single hard condition common to all routes: the subsidiary must be legally incorporated in the issuing country.
• The expanded routes only apply where the product is manufactured by a third party or a subsidiary and is not sold in the country of manufacture.
• Article 10.19 still requires the CLV to state the manufacturer, product name and identification code clearly.

2. Legal basis

The revised definition and its supporting provisions are set out below, including the certification and translation rules that imported CLVs must satisfy.

3. Expert insights

Insight 1. Before the amendment, Article 4.7 offered only two issuing authorities; after it, there are four, and the three additions all revolve around the holder and the parent company. The pre-amendment text read podrá ser emitido por la autoridad competente del país del titular del producto — only the country of the product holder. The amended text expands this to three further routes: the country of the holder, the country of the holder’s subsidiary, and the country of the subsidiary of the parent company, the latter subject to the condition that the product holder belongs to the same parent company (siempre que el titular del producto pertenezca a la misma casa matriz). This design turns the corporate group structure into a compliance resource.

Insight 2. The requirement that the subsidiary be legally incorporated in the issuing country is the common precondition of all four routes and the only hard condition. The final sentence of Article 4.7 reads En cualquier caso, la filial debe estar legalmente constituida en el país de emisión del certificado. The meaning is that whichever route is chosen, the entity in the issuing country must be a legally incorporated subsidiary — not a liaison office, a representative office, or a branch without separate legal personality. This condition should be verified before the issuing country is selected, not after.

Insight 3. The new routes form a convenience-plus-gate pairing with the third paragraph of Article 17.3. Article 4.7 widens the sources of the CLV, but the third paragraph of Article 17.3, amended in the same decree, provides that once a registration that enjoys mutual recognition submits a CLV issued by a country with no mutual recognition arrangement, the full supplementation obligations of Articles 11, 12 and 13 are triggered. The message is plain: the issuing authority can be changed, but changing it to a non-recognition country carries the price of completing the entire documentation set. The two provisions must be assessed together.

Insight 4. The motive for the amendment is stated expressly in the decree’s recitals. Article 5 of the 2024 amending decree records in its CONSIDERANDO that one purpose of the change is permitir que el Certificado de Libre Venta sea emitido también por la autoridad competente del país de una filial de la empresa titular del EMB o de la casa matriz — to allow the certificate also to be issued by the competent authority of the country of a subsidiary of the holder or of the parent company. This gives companies a legislative rationale that can be cited directly when corresponding with the Ministry of Health.

4. Practical recommendations

• Screen the feasible issuing countries against the four categories of Article 4.7 in order: country of origin, then the holder’s country, then the holder’s subsidiary’s country, then the parent company’s subsidiary’s country.
• Before fixing the issuing country, verify that the subsidiary is legally incorporated there (with separate legal personality) and retain proof of incorporation.
• Assess the third paragraph of Article 17.3 at the same time: if the new issuing country is not a mutual-recognition country, calculate the full supplementation cost before switching.
• Ensure the CLV clearly states the manufacturer’s name, the product name and the identification code under Article 10.19; where no code exists, process the alternative evidence under Articles 10.19 to 10.22.
• Retain the CONSIDERANDO of Article 5 of the 2024 amending decree as the legislative rationale, ready to be cited in response to reviewer queries.

5. Verification checklist

• □ Issuing countries screened against the four categories of Article 4.7
• □ Proof of legal incorporation of the subsidiary in the issuing country verified
• □ CLV states the manufacturer, product name and identification code (10.19)
• □ Mutual-recognition break risk under the third paragraph of Article 17.3 assessed
• □ Certification / apostille and notarial certification processed under Article 10.17
• □ CONSIDERANDO legislative rationale of the amending decree retained on file

Related reading: [Declaration letter when the CLV omits the holder’s name](/costa-rica-medical-device-registration/clv-missing-holder-name-declaration-letter/) | [Equivalence break risk: the amended Article 17.3 after 2024](/costa-rica-medical-device-registration/equivalence-break-risk-after-2024-amendment/) | [Three-tier alternative evidence when the CLV lacks product codes](/costa-rica-medical-device-registration/clv-without-product-codes-alternative-evidence/)

Regulatory information verified as of October 29, 2026.

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