NTON 24001 Scope and Field of Application

1. Key takeaways

Chapter 2, CAMPO DE APLICACIÓN, of NTON 24001:2023 confines the scope to five categories of actors: natural or legal persons who manufacture (fabrican), refurbish or upgrade (repotencian), reprocess (reprocesan), re-sterilise (reesterilizan) or import (importan) medical devices for distribution and commercialisation. Chapter 1, OBJETO, confines the purpose to the sanitary registration of devices for human use. GRZAN regulatory team note: the verbs of the scope clause are an exhaustive list; purely local distribution, pure retail and in-house use by healthcare institutions are not within the letter of Chapter 2. However, Chapter 5 Articles 1 and 6 pull the circulation end back into the chain of obligations through two provisions: importers or distributors must comply, and operating a business requires a licence.

2. Legal basis

The table below maps the scope provisions of the standard and the resolution, together with the definitions that give refurbished, second-hand and controlled-technology equipment their boundaries.

3. Expert insights

Point 1: The five verbs of Chapter 2 are an exhaustive list, not examples. The original text reads fabrican, repotencian, reprocesan, reesterilizan o importan: manufacture, refurbish, reprocess, re-sterilise, import. These five actions cover every point of origin through which a product can enter the Nicaraguan market: made locally, refurbished locally, reprocessed locally, re-sterilised locally, or brought in from abroad.

Point 2: The scope of RA 0007/2025 is wider than Chapter 2 of the NTON. Article 1 of Annex I of the resolution addresses establishments engaged in manufacture, maintenance and repair, refurbishment, reprocessing, sterilisation or re-sterilisation, repackaging, import, distribution and commercialisation, and Article 2 goes further by capturing users (utilicen) as well. The reason is that the resolution governs the sanitary licence, an establishment qualification, while Chapter 2 of the NTON governs sanitary registration, a product qualification. The two lines have different scopes and cannot be applied to each other.

Point 3: Refurbished and second-hand equipment have dedicated statutory definitions and an age limit. Definition item 20 confines refurbished equipment to equipment whose main subsystems have been replaced with new parts by the manufacturer or a refurbisher authorised by the manufacturer, and which conforms to the manufacturer specifications and the original construction safety standards. Definition item 21 confines second-hand equipment to equipment used for no more than 5 years, counted from manufacture or assembly. Both are placed by definition item 10 into controlled-technology devices, alongside Class III and IV devices and prototypes.

Point 4: Distribution and commercialisation fall outside the verbs of Chapter 2 yet return through Chapter 5. Chapter 5 Article 1 requires the importer or distributor to complete registration by risk class before the goods enter the country; Chapter 5 Article 6 requires establishments engaged in manufacture, import or distribution to hold a valid sanitary licence. A distributor is therefore not a bystander: it is one of the bearers of the registration obligation and also a licence holder.

Point 5: Chapter 2 does not cover in-house use by healthcare institutions. The closing phrase of Chapter 2 is para su distribución y comercialización, for their distribution and commercialisation. Although Article 2 of RA 0007/2025 brings users within its own scope, that provision addresses sanitary licensing matters. Whether an entity falls within Chapter 2 of the NTON turns on whether its conduct is directed at distribution and commercialisation.

Point 6: The purpose clause confines the object to human use. Chapter 1 reads dispositivos médicos de uso humano, devices for human use, and Articles 1 and 3 of RA 0007/2025 likewise emphasise de uso humano repeatedly. Veterinary devices are outside this volume, and this point creates no exception when preparing labels and monographs.

4. Practical recommendations

• Establish actor identity through the five verbs: first confirm whether the activity is manufacture, refurbishment, reprocessing, re-sterilisation or import, and only then determine the registration obligation and licence category. Do not pass over the question with the phrase we are a distributor.
• File second-hand and refurbished equipment separately: verify subsystem replacement records, manufacturer authorisations and the 5-year limit against items 20 and 21, and prepare the dossier as controlled-technology devices under item 10.
• Have distributors obtain the licence in parallel: Chapter 5 Article 6 requires distribution establishments to hold a valid sanitary licence and to perform only the licensed activities; changing the scope of business requires changing the licence first.
• Run establishment qualification and product qualification as two separate applications: the sanitary licence goes through the establishment channel of RA 0007/2025 and the sanitary registration through the product channel of Chapter 6 of the NTON. Do not merge them into one application.
• Map user-side obligations separately: healthcare institutions are users within Article 2 of RA 0007/2025, and their licensing and product registration obligations differ; this must be made clear in client training material.
• Write the human-use limitation into internal templates: the product name and intended-use descriptions in all external documents should carry de uso humano uniformly, to prevent veterinary products from being handled with the same set of documents.

5. Verification checklist

• □ The actor activity category has been confirmed against the five verbs of Chapter 2 and the determination record retained
• □ The product has been confirmed to be a device for human use
• □ For second-hand or refurbished equipment, replacement records and the 5-year limit have been verified against items 20 and 21
• □ Controlled-technology devices have been captured under item 10 and the dossier prepared to Class III or IV standards
• □ The distribution establishment holds a valid sanitary licence covering its business activities
• □ Establishment licensing and product registration have been filed through separate channels and not merged
• □ External documents uniformly carry the marking de uso humano

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 through the regulatory directorate, prepares Spanish-language dossiers, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com