Forty-One Definitions in NTON 24001

1. Key takeaways

Chapter 4, TÉRMINOS Y DEFINICIONES, of NTON 24001:2023 lists 41 definitions and closes the chapter with 11 abbreviations (CE, CSA, ECRI, FDA, GHTF, IEC, ISO, IVD, MDSAP, OMS, OPS, UL). Among the 41, 5 items directly shape the structure of an application: item 1 accessory, item 18 distributor, item 27 legal manufacturer, item 30 importer and item 41 registration holder; and 1 item sets the classification scale, namely item 33 on the four risk classes. GRZAN regulatory team note: definition item 41 defines the Titular as the party that grants the authorisations for distribution, registration and legal representation, which is the opposite of the reading common in many markets, where the registration holder is understood as the authorised local entity; this is the single most misread provision in the volume.

2. Legal basis

The table below lists the definitions with the greatest structural weight and the content each settles.

3. Expert insights

Point 1: Item 41 positions the Titular as the granting party, not the granted party. The original text reads Entidad que otorga las autorizaciones de distribución, registro y/o representación legal a favor de la persona natural o jurídica designada en el país: the entity that grants the authorisations for distribution, registration or legal representation in favour of the person designated in the country. The product owner, which may be a foreign entity, therefore stands at the top of the chain, and Nicaraguan companies and individuals are its downstream grantees. This provision directly refutes the industry claim that the registration holder must be a locally incorporated Nicaraguan company.

Point 2: The legal manufacturer and the manufacturer are two distinct roles, and the data form requires them to be entered separately. Item 2, subparagraphs f, g and h of Chapter 6 require three separate sets of data: Manufacturador (the production plant), Titular (the registration holder) and Fabricante legal (the legal manufacturer). Item 27 defines the legal manufacturer as the owner of the device and the person bearing legal responsibility, and item 28 defines the manufacturer as the party responsible for the design or manufacture that places the device on the market under its own name. In an OEM arrangement the three roles can be held by three different companies.

Point 3: The 7 notes of item 27 decide who counts as a manufacturer. Note 5 is the key one: any person who changes the intended use of a device, or modifies it, and places it on the market not in the name of the original manufacturer but under its own name, is to be regarded as the manufacturer of the modified device. For private-label and relabelling businesses this is the direct qualification test. Note 6 then provides the exemption: a representative, distributor or importer who only adds its own address and contact details to the device or packaging, without covering or altering the existing labelling, is not regarded as the manufacturer.

Point 4: The definition of distributor excludes pure warehousing and transport parties. Item 18 derives from clause 3.5 of ISO 13485:2016, and its two notes state that there may be several distributors in the supply chain, but that entities engaged in warehousing and transport on behalf of a manufacturer, importer or distributor are not distributors. This determines that item 3 of Chapter 6 requires the valid sanitary licence copy of the authorised distributor, not a logistics company qualification.

Point 5: Item 33 gives the semantics of the four classes, not numerical criteria. Class I means very low risk, Class II low to moderate, Class III moderate to high, and Class IV the most critical devices in terms of risk. These semantics operate together with the 26 rules of Annex B: the rules give the decision path, and item 33 gives the meaning of each class.

Point 6: The abbreviation table reveals the evidence preferences of the standard. The chapter closes with CE, CSA, ECRI, FDA, GHTF, IEC, ISO, IVD, MDSAP, OMS, OPS and UL, of which MDSAP and ECRI deserve particular attention: the former triggers the monograph exemption in the note to item 12 of Chapter 6, and the latter is one of the issuing bodies of international safety alerts under item 9 of Chapter 10.

4. Practical recommendations

• Reconfirm the holder architecture against item 41: place the product owner, which may be a foreign entity, in the granting position, and the Nicaraguan representatives and distributors in the granted position, with the powers of attorney issued in that direction.
• Prepare the three sets of entity data separately: under item 2, subparagraphs f, g and h of Chapter 6, compile the trade name, country, address, telephone and email of the Manufacturador, the Titular and the Fabricante legal separately, and do not mix them in OEM arrangements.
• Qualify private-label and relabelling businesses against the manufacturer test first: under note 5 of item 27 assess whether changing the intended use or marketing under one’s own name makes the party a manufacturer, and under note 6 ensure the exemption applies by never covering or altering the original labelling.
• Take distributor qualifications under item 18: submit the sanitary licence copy of the authorised distributor, and do not prepare qualification material for pure warehousing and transport parties.
• State classification conclusions using the semantics of item 33: external documents should give both the class number and the risk semantics, to avoid ambiguity from a bare Class III.
• Align the evidence chain with the abbreviation table: where possible have ISO 13485 issued by an MDSAP-recognised body, to trigger the monograph exemption in the note to item 12 of Chapter 6.

5. Verification checklist

• □ The holder architecture and direction of authorisation have been confirmed against definition item 41
• □ The three sets of data for the production plant, the registration holder and the legal manufacturer have been compiled separately under item 2 of Chapter 6
• □ Private-label or relabelling businesses have been qualified against notes 5 and 6 of item 27
• □ A copy of the valid sanitary licence of the authorised distributor (not a pure warehousing or transport party) has been submitted
• □ Class designations in external documents carry both the number and the risk semantics
• □ The issuing body of the ISO 13485 certificate has been checked for MDSAP recognition
• □ Internal terminology abbreviations have been unified against the Chapter 4 abbreviation list

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