Medical Device Definition and Software as a Medical Device

1. Key takeaways

The test for what counts as a medical device in Nicaragua is definition item 7 of NTON 24001:2023, which adopts the seven-item intended-purpose list of GHTF/SG1/N071:2012 and expressly brings software (incluido el software para su funcionamiento), implants, in vitro diagnostic reagents, calibrators and control materials within scope. In addition, the definition separately captures assistive products for persons with disabilities, dedicated accessories, aesthetic or cosmetic items that carry comparable risks, and RUO and molecular biology reagents and orphan in vitro diagnostic reagents. The draft Adenda 2026-05 (Ad.01), currently under consultation, proposes to add to Chapter 4 a definition of SaMD (Software como Dispositivo Médico) together with 7 clarifying notes. GRZAN regulatory team note: the current Nicaraguan device definition contains no standalone SaMD entry; software is handled through the phrase about software needed for the device to function in item 7 and through Rule 11 of Annex B, and this is the gap that Ad.01 is intended to close.

2. Legal basis

The table below sets out the provisions that determine whether a product falls within the device definition, how software is classified, and what the pending amendment would change.

3. Expert insights

Point 1: Item 7 already covers software, but only software that runs with a device. The original phrase incluido el software para su funcionamiento means software needed for the device to function. Software sold on its own, without forming part of a hardware device, has no dedicated entry in the current text. This is a genuine gap in the text, not something we have overlooked.

Point 2: The SaMD definition in Ad.01 takes over the IMDRF wording and adds 7 notes. The proposed text defines SaMD as software intended for one or more medical purposes that performs those purposes without being part of a hardware device, and states expressly that SaMD may include IVD software; that it may run on general-purpose (non-medical) computing platforms; that not being a component means the software is not necessary for a hardware device to achieve its intended medical purpose; that software whose intended purpose is to drive a hardware device does not constitute SaMD; that SaMD may be combined or interconnected with other products, including other medical devices; and that mobile applications meeting the definition are SaMD.

Point 3: Annex B Rule 11 is the only landing point for software classification in the current text. Rule 11 has three tiers. Software that provides information used for therapeutic or diagnostic decisions is Class II; where that decision could lead to death or an irreversible deterioration in health it is Class IV, and where it could lead to serious deterioration or require surgical intervention it is Class III. Software used to monitor physiological processes is Class II, and Class III where the vital parameters monitored could, if varied, immediately endanger the patient. All other software is Class I. This scale ties classification directly to the risk consequence and shares its structure with Rule 11 of the EU MDR.

Point 4: Aesthetic and cosmetic devices are expressly captured, but behind a risk threshold. Item 7 brings in products, equipment, apparatus or instruments used for aesthetic or cosmetic purposes on condition that, because of their characteristics, they may pose health risks similar to those of conventional medical devices. This is not unconditional inclusion; ordinary low-risk cosmetic products fall outside it.

Point 5: RUO and IUO products are regulated but carry the lowest classes. Definition items 36, 37 and 38 distinguish RUO (research use only, with performance not verified by the manufacturer for direct diagnosis), IUO (testing in the development stage) and orphan in vitro reagents. Annex B Rule 25 provides that RUO and IUO products are in principle Class I, but nucleic acid sequencing, primer, sample preparation, amplification, detection and quantification reagents for molecular biology are Class II, and monoclonal and polyclonal antibodies for oncology, immunology and epigenetics are Class III.

Point 6: Accessories are devices in their own right, with their own responsible party. Definition item 1 and item 7 both capture accessories specifically designated by the manufacturer for use with a main device to enable it to achieve its intended use. Note 7 on the legal manufacturer in Article 4 of Annex I to RA 0007/2025 further clarifies that whoever is responsible for the design or manufacture of the accessory is treated as its manufacturer. An accessory is not an annex to the main device dossier; it is an independent registration object.

4. Practical recommendations

• Determine the nature of the product before planning the project: compare the intended use against the seven intended purposes of item 7 one by one; any match makes the product a device. For aesthetic items, run a second test on whether the risks resemble those of conventional devices.
• Pre-classify software products under Annex B Rule 11: assess whether the consequences of the software output could cause death, irreversible harm, serious harm or the need for surgery, and use that to anticipate a Class II, III or IV outcome and prepare the corresponding clinical evidence.
• Position standalone software against Ad.01 in advance: if the product is a SaMD sold on its own, assemble the evidence chain against the proposed definition (operation on a general-purpose platform, not being a hardware component, mobile app attributes), so it can be plugged in as soon as Ad.01 is adopted.
• Do not treat RUO and IUO as ordinary IVDs: classify them under Annex B Rule 25; molecular biology reagents and oncology and immunology antibodies sit above ordinary research reagents.
• Plan accessories as separate registration units: assess the main device and its dedicated accessories separately under definition item 1, and do not assume an accessory can ride on the main device.
• Track Ad.01: the CNNC public consultation page and the WTO TBT notification (G/TBT/N/NIC/178/Add.1) are the two channels that can be followed.

5. Verification checklist

• □ The product has been qualified against the seven intended purposes of item 7 and the determination record retained
• □ Software products have been pre-classified under Annex B Rule 11
• □ The evidence chain for standalone software has been assembled against the proposed SaMD definition of Ad.01
• □ Aesthetic products have passed the second test on whether risks resemble those of conventional devices
• □ RUO and IUO products have been classified under Annex B Rule 25
• □ Dedicated accessories have been assessed as independent registration units under definition item 1
• □ The CNNC public consultation page and WTO TBT notifications have been set up as tracking channels for Ad.01

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