Ionising Radiation Devices: The Additional Authorisation Under Ley 156

1. Key takeaways

A device that emits ionising radiation needs more than a sanitary registration in Nicaragua. Chapter 5, Article 2 of NTON 24001:2023 requires that importers or distributors of such devices also be authorised under Ley No. 156, the Ley sobre Radiaciones Ionizantes: «deberán estar autorizados de conformidad a lo establecido en la Ley 156». This is the only category within device regulation that is separately authorised by a dedicated law. The classification rules in Annex B also raise the relevant radiation scenarios together: rule 6 b covers transient-use surgically invasive devices that administer energy in the form of ionising radiation and places them in class III; rule 9 covers active therapeutic devices emitting ionising radiation, and devices that monitor or directly influence their operation, also class III; rule 10 covers diagnostic radiology and interventional radiology equipment emitting ionising radiation, and equipment that monitors or directly influences it, again class III.

• Importers or distributors of radiation-emitting devices need a Ley 156 authorisation (Chapter 5, Article 2).
• The obligation sits with the importer or distributor, not with the overseas manufacturer.
• Rule 6 b of Annex B places the relevant surgically invasive devices in class III.
• Rules 9 and 10 place therapeutic, diagnostic and interventional radiology devices in class III.
• ANRS is the authority for the management and control of ionising radiation (Ley 1068, Article 10 item 7).
• Classification runs rule by rule, not by the mere presence of a radiation source.

2. Legal basis

Three instruments meet here: the technical standard that refers outwards, the special law to which it refers, and the framework law that assigns the authority. The table sets them out with the classification rules.

3. Expert insights

Insight one: the duty holder is the importer or distributor. Chapter 5, Article 2 addresses «Los importadores o distribuidores que importen», which matches the party carrying the registration obligation under Chapter 5, Article 1. The radiation authorisation and the product registration therefore fall on the same set of entities, and no appearance by the overseas manufacturer is required.

Insight two: this is a further case of permission beyond registration. Four requirements come from different sources: the operating licence under Chapter 5, Article 6, which applies to all establishments; the radiation authorisation under Ley 156, which applies to radiation devices; and the procedural platform requirements under RA 0007/2025 and RA 0020/2025. They do not substitute for one another and each has to be satisfied separately.

Insight three: Annex B groups the radiation scenarios at class III, with one higher exception. Rules 6 b, the third paragraph of rule 9 and the final paragraph of rule 10 all point to class III. Rule 9 also contains a higher category: active devices intended to monitor or directly influence the operation of implantable active devices are class IV. Classification is decided by the specific rule, not by a single question about whether a radiation source is present.

Insight four: classification can pull in definition 10. Devices classified as class III and IV under the standard meet one of the constitutive elements of definition 10, controlled technology devices, and are then subject to special controls. Radiation devices are therefore weighted on two dimensions at once, class and special control.

Insight five: the publication details of Ley 156 are not verified here. The law is cited only through Chapter 5, Article 2 of the standard and through the list of enabling laws in RA 0007/2025 (Ley 1068, Article 10 item 2 d). Any citation should rely on the official text; this review does not supply publication information it has not checked.

Insight six: testing scope does not follow automatically from the radiation attribute. Chapter 6, item 14 and Article 14 of Anexo I to RA 0007/2025 refer the list of products subject to testing to RA 0029/2024, the Guía del programa de vigilancia de mercado. The full guide was not obtained for this review, so no assumption is made that radiation devices are necessarily tested.

4. Practical recommendations

• Add emits ionising radiation as a separate flag in the product intake list, so the attribute is caught at selection stage.
• Build the compliance list for radiation devices across four layers: product registration, operating licence, Ley 156 authorisation and platform procedure requirements.
• Classify against the specific rules in Annex B — 6 b, 9 and 10 — rather than assigning class III whenever a source is present.
• Where class III or IV applies, assess at the same time whether definition 10 on controlled technology devices is engaged.
• Cite Ley 156 from the official text, since its publication number and date were not verified here.
• Confirm testing scope against the RA 0029/2024 list in force and DDM practice rather than inferring it from the radiation attribute.

5. Verification checklist

• □ Emits ionising radiation is recorded as a separate flag in the product intake list
• □ The compliance list covers four layers: registration, operating licence, Ley 156 authorisation and platform procedure
• □ Classification has been decided rule by rule under Annex B, rules 6 b, 9 and 10
• □ Where class III or IV applies, definition 10 has been assessed
• □ Citations to Ley 156 note that the official text governs
• □ Testing scope has been confirmed against the RA 0029/2024 list in force and DDM practice

Regulatory information verified as of 29 October 2026.

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support for the Nicaraguan 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