Sanitary operating permit for establishments

1. Key takeaways

The operating permit is the company-side threshold and runs in parallel with product registration. Article 10.4 of the technical regulation provides that domestic manufacturers (for products manufactured in Costa Rica) or importers (for products manufactured abroad) must hold a current, valid sanitary operating permit (permiso sanitario de funcionamiento) that corresponds to the activities they carry on; the Ministry of Health verifies this permit internally. Article 11.2 adds one requirement for domestic manufacturers: the permit must state EMB manufacturing as an authorised activity. Article 18.8.1 further requires that any newly appointed distributor likewise hold a valid operating permit. The conclusion is that the operating permit is an entity-level gate: it is not replaced by the product registration, and it does not replace it. A registration answers whether a given EMB may be marketed; the operating permit answers whether the enterprise is allowed to conduct the activity at all. Both must stand at the same time.

2. Legal basis

The following provisions of RTCR 505:2022 establish the operating permit requirement for manufacturers and importers, the extra labelling requirement for domestic manufacturers, and the recurring permit conditions embedded in the change provisions of Article 18.

3. Expert insights

Insight 1: internal verification is a procedural convenience, not a lowered substantive bar. The phrase used in Article 10.4 — verificado a nivel interno — means that when filing a registration the company does not have to attach the operating permit, because the Ministry will verify it on its own side. But the substantive condition is not waived: Articles 18.8.1, 18.9.1, 18.11.2, 18.16.1 and 18.18.1 restate the validity of the permit across the whole range of change scenarios. The meaning is that the status of the permit is a continuing condition; it is merely verified by different means at different stages. A lapsed permit will resurface as a blocker the moment any entity-level change is filed.

Insight 2: the activity-labelling requirement of Article 11.2 is a substantive difference between the domestic and import routes. An importer needs only a permit that corresponds to the activities it actually carries on (Article 10.4); a domestic manufacturer must have the permit expressly state fabricación de Equipo y Material Biomédico — manufacture of biomedical equipment and material — as its authorised activity. The difference persists in change proceedings: Article 18.9.1, on a change of domestic manufacturer, refers back to Article 11.2, and Article 18.11.2 requires that on a change of manufacturing site the permit be valid and updated (vigente y actualizado). Checking the wording of the permit’s activity line should therefore be part of supplier qualification for any local production partner.

Insight 3: the operating permit and the product registration are parallel lines, and the expiry of either one interrupts the business. Product registration answers whether a given EMB may be sold; the operating permit answers whether the enterprise may perform the activity. Article 10.4 regulates both side by side, which confirms that neither substitutes for the other. The most common practical risk is that a company focuses all its attention on the registration’s own validity period (Article 15, five years) while overlooking the separate expiry dates of the operating permit, the power of attorney (Article 11.9) and the manufacturing contract (Article 11.8.7). Each of those documents can silently lapse while the registration itself remains nominally valid.

Insight 4: the multiple permit conditions in Article 18 form a cross-verification net. Change of distributors (18.8.1), change of manufacturer (18.9.1), change of manufacturing site (18.11.2), simultaneous change of holder and manufacturer (18.16.1) and change of the holder’s address (18.18.1) — five places all require a valid permit. The design implies that every change of entity or premises re-triggers a qualification check. Companies planning supply-chain adjustments must therefore audit the permit status of each affected entity at the same time as they plan the commercial transition, rather than discovering the condition at filing.

4. Practical recommendations

• Check permits separately by role: importers verify that the permit matches their activities under Article 10.4; domestic manufacturers verify that the permit states EMB manufacturing under Article 11.2.
• Build an entity-qualification register that monitors the expiry dates of three document families in parallel — operating permit, power of attorney and manufacturing contract — not only the registration certificate.
• Before any change of distributor, manufacturer or production site, verify the new entity’s permit validity under the corresponding provision of Article 18.
• When changing the manufacturing site, confirm that the domestic manufacturer’s permit is valid and updated (Article 18.11.2).
• Record the two verification modes clearly: at registration the permit is verified internally by the Ministry (Article 10.4), while at changes it operates as a submission condition (Article 18).

5. Verification checklist

• □ Importer holds a valid permit matching its activities (Article 10.4)
• □ Domestic manufacturer’s permit states EMB manufacturing (Article 11.2)
• □ Entity register covers permit, power of attorney and contract expiry dates
• □ Entity or site changes checked against the new entity’s permit (18.8.1 / 18.9.1 / 18.11.2 / 18.16.1 / 18.18.1)
• □ Site change confirmed with an updated permit (Article 18.11.2)
• □ Both verification modes recorded

Related reading: [Licensing and changes for importers and authorised distributors](/costa-rica-medical-device-registration/importer-and-authorised-distributors/) | [Nineteen categories of post-registration changes and four notification items](/costa-rica-medical-device-registration/post-registration-changes-nineteen-categories/) | [Top-up obligations when a manufacturing site change alters the country of origin](/costa-rica-medical-device-registration/manufacturing-site-change-country-of-origin/)

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