Importer and authorised distributors

1. Key takeaways

Yes, third parties may import and distribute — but only through a declared channel. Article 10.11 of the technical regulation provides that the product holder or its legal representative may authorise third parties to import or distribute the product (the authorised distributors, distribuidores autorizados), provided that this is stated in the registration application or effected through a post-registration change. Article 18.8 classifies the change or expansion of distributors as one category of post-registration change and requires that the new distributor hold a valid operating permit; for EMB involving ionising radiation, the new distributor must also hold a current, valid radiation source authorisation. Article 10.4 adds that the importer itself must hold a valid sanitary operating permit that corresponds to its activities. The combined effect: distribution is not a private commercial arrangement that the regulator tolerates — it is a regulated structure in which every participant must hold the relevant permits and every addition or substitution must be declared.

2. Legal basis

The provisions below define who may distribute, what permits each participant needs, and how distributor changes are processed.

3. Expert insights

Insight 1: Article 10.11 closes the two lawful pathways for appointing distributors. The ways to establish an authorised distributor are limited to two: stating the arrangement in the registration application, or processing it as a post-registration change. The source text reads: siempre y cuando así lo indique en la solicitud de registro o mediante cambio post registro. The meaning is that a company may not unilaterally add distributors after approval without filing. Read together with the first paragraph of Article 18, a change or expansion of distributors falls into the notification category — the processing burden is lower, but the filing must still be made. Distributor appointments made purely under commercial contracts, without any regulatory filing, sit outside the compliant structure.

Insight 2: the operating permit requirements attach separately to importers and distributors, and Article 10.4 states that verification is internal. The text of Article 10.4 says: El permiso sanitario de funcionamiento indicado anteriormente será verificado a nivel interno — the Ministry of Health will verify internally the sanitary operating permit, and companies are not required to submit the permit as part of the registration file. Yet Article 18.8.1 still requires any new distributor to hold a valid permit. The meaning is that the validity of the permit is a substantive condition of compliance; only the manner of verification is different, being carried out inside the Ministry. Companies should therefore keep their own permits current at all times, because the absence of a submission obligation does not mean the absence of the requirement.

Insight 3: ionising-radiation products carry a dual qualification at the distributor level. Article 10.12 provides that for EMB emitting ionising radiation, the holder, the legal representative and each authorised distributor must hold the radiation source authorisation in its own name; Article 18.8.2 restates this when distributors change. The practical consequence is that every newly added distributor needs a radiation source authorisation issued in that distributor’s name (under DE 24037-S) — one more layer of paperwork than for ordinary products. Planning distributor appointments for radiological equipment therefore means sequencing the radiation authorisation alongside the commercial onboarding, not after it.

Insight 4: Article 11.2 imposes an activity-labelling requirement on domestic manufacturers that does not apply to importers. The text requires an operating permit that states as its activity fabricación de Equipo y Material Biomédico — manufacture of biomedical equipment and material. This is the difference between the domestic manufacturing route and the import route: an importer needs only a permit that corresponds to its activities (Article 10.4), whereas a domestic manufacturer’s permit must expressly list EMB manufacturing as the authorised activity. When auditing a local manufacturing partner, this line item on the permit should be checked verbatim, not assumed.

4. Practical recommendations

• Name the authorised distributors in the registration application; for additions or changes after approval, file under Article 18.8 as a notification-type change.
• Confirm the importer holds a valid sanitary operating permit matching its activities (Article 10.4); confirm the domestic manufacturer’s permit states EMB manufacturing (Article 11.2).
• Before adding a distributor, verify the validity of its operating permit; for ionising-radiation products, also verify its radiation source authorisation (Article 18.8.2).
• For ionising-radiation products, obtain the radiation source authorisation separately in the name of the holder, the legal representative and every authorised distributor, per Article 10.12.
• Keep the distributor list in the registration register, consistent with the registration certificate and the labelling information.

5. Verification checklist

• □ Authorised distributors stated in the application or handled through a change filing (Article 10.11)
• □ Importer holds a valid operating permit (Article 10.4)
• □ Domestic manufacturer’s permit states EMB manufacturing (Article 11.2)
• □ New distributors’ operating permits verified (Article 18.8.1)
• □ Ionising-radiation distributors hold the radiation source authorisation (Article 18.8.2)
• □ Distributor list recorded in the register and consistent with labelling

Related reading: [The sanitary operating permit: thresholds for local manufacturers and importers](/costa-rica-medical-device-registration/sanitary-operating-permit-for-establishments/) | [Ionising radiation source authorisation: Article 11.6 and DE 24037-S](/costa-rica-medical-device-registration/ionising-radiation-source-authorisation/) | [Nineteen categories of post-registration changes and four notification items](/costa-rica-medical-device-registration/post-registration-changes-nineteen-categories/)

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