Ionising radiation source authorisation

1. Key takeaways

EMB that contain ionising radiation sources must obtain a separate radiation source authorisation, issued by the Ministry of Health’s Directorate of Radiological Protection and Environmental Health, on the legal basis of Decreto Ejecutivo N° 24037-S (1994-12-22, La Gaceta N° 48, 1995-03-08). The technical regulation places this requirement in four places: Article 10.12 (the holder, the legal representative and each authorised distributor must all hold it), Article 11.6 (a dossier item for registration), Article 16.9 (at renewal it must be updated and valid), and Articles 18.8.2 / 18.9.6 / 18.10.5 / 18.16.7 (required when adding a distributor, changing the manufacturer, changing a family/group/system/test kit composition, or changing the holder and manufacturer together). In short, this is a parallel licence that runs through the entire product lifecycle, from first registration through every change to renewal, and it is held per entity rather than per product file.

2. Legal basis

The table below collects the provisions that impose the radiation source authorisation, the decree that constitutes its substantive legal basis, and the classification rule that assigns radiological products to their risk classes.

3. Expert insights

Insight 1: Article 11.6 differs from every other dossier item — it demands possession, not submission. The provision is worded as Contar con la autorización de la fuente de emisión de radiaciones — to hold the authorisation, not to file it. Combined with Article 10.12, which requires separate holding in the name of the holder, the legal representative and each distributor, the authorisation is in substance an entity qualification, of the same nature as the sanitary operating permit under Article 10.4. Companies should therefore schedule it as a company-side workstream running parallel to the product registration, not as an attachment to be gathered for the dossier. Treating it as paperwork for the file understates both its lead time and its renewal burden.

Insight 2: the regulation itself uses two different names for the issuing directorate, and this should be handled deliberately. Article 11.6 writes Dirección de Protección Radiológica y Salud Ambiental; Articles 18.10.5 and 18.16.7 write Dirección de Protección al Ambiente Humano. This volume adopts the Article 11.6 designation (Directorate of Radiological Protection and Environmental Health) throughout, and recommends that external documents state the directorate’s function alongside its name, so that a formal review does not reject the filing over a nominal mismatch. Where an official form or portal uses one of the two designations, follow that document’s wording in the corresponding field.

Insight 3: Annex A Rule 8 classifies radiological products in more detail than the other rules, and software is expressly swept in. Rule 8 provides that active EMB emitting ionising radiation — including devices or software that control or monitor the equipment or directly affect its performance — are Class 3; radiographic mode (modo radiográfico) devices are Class 2; and mammography (mammografías), although a radiographic use, remains Class 3. The consequence is that two radiological devices with different intended uses can fall into different classes, with different documentation levels attached. Software that merely controls or monitors the emitter is not carved out of the device classification; it is pulled in with it.

Insight 4: Article 16.9 makes the authorisation a hard precondition of renewal, valid across all named entities. The renewal provision requires the authorisation to be updated and valid (actualizada y vigente) and lists it alongside the application form, the CLV and the labelling as renewal materials (Article 16). Read with Article 10.12, the meaning is that before renewal the authorisations of the holder, the legal representative and all authorised distributors must all be inside their validity. The lapse of any single entity’s authorisation blocks the renewal. This is why the authorisation register should be maintained per entity with expiry dates, not per product.

4. Practical recommendations

• For products containing radiation sources, schedule the radiation source authorisation as a company-side parallel workstream, running alongside the product registration.
• Obtain the authorisation separately in the name of the holder, the legal representative and every authorised distributor under Article 10.12; do not share a single document among entities.
• Before renewal, verify under Article 16.9 that the authorisations of all three categories of entity are updated and valid.
• When adding a distributor, changing the manufacturer, changing a composition, or changing holder and manufacturer together, process the authorisation in step with the corresponding Article 18 filing.
• Determine classification under Annex A Rule 8: radiographic mode devices are Class 2, mammography and other radiological devices are Class 3, and configure the documentation level accordingly.

5. Verification checklist

• □ Confirmed whether the product contains an ionising radiation source
• □ Radiation source authorisation obtained under Article 11.6
• □ Held separately by the holder, the legal representative and each distributor (Article 10.12)
• □ Before renewal, authorisations checked as updated and valid under Article 16.9
• □ Authorisation processed in step with each Article 18 change
• □ Classification determined under Annex A Rule 8

Related reading: [Licensing and changes for importers and authorised distributors](/costa-rica-medical-device-registration/importer-and-authorised-distributors/) | [The sanitary operating permit: thresholds for local manufacturers and importers](/costa-rica-medical-device-registration/sanitary-operating-permit-for-establishments/) | [The four risk classes and the highest-risk-wins principle](/costa-rica-medical-device-registration/four-risk-classes-and-highest-risk-rule/)

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