ISO 13485 and the MDSAP Exemption for Monograph Items

1. Key takeaways

The NOTA to item 12 of Chapter 6 of NTON 24001:2023 provides the only waiver channel on the checklist: a manufacturer that submits an ISO 13485 certificate issued by a certification body whose accreditation is recognised under MDSAP may waive the cited sub-items. It should be noted that, on checking the official text, the NOTA refers to numeral 13, incisos a, b, c, d, e, f de este capítulo, whereas sub-items a to f are in fact located in item 12 (the product monograph); item 13 (samples) has no sub-items. This is an inconsistency in cross-referencing within the official text. This volume reads the reference as item 12, sub-items a to f, and recommends obtaining written confirmation from DDM.

• The exemption turns on the accreditation of the issuing body, not on possession of an ISO 13485 certificate as such.
• The waiver covers six sub-items, not the whole monograph; sub-items g to l remain due.
• The official NOTA cites numeral 13 while the sub-items sit in numeral 12, a discrepancy worth confirming in writing.
• A second relief path exists within sub-item c, for biocompatibility data on products made and sold in countries with reference regulatory authorities.
• The ISO 13485 certificate itself must still be filed under item 8, with legalisation where no verification mechanism is shown.

2. Legal basis

The provisions below set out the certificate requirement in item 8, the waiver in the NOTA to item 12, and the six sub-items that the waiver covers, alongside the separate biocompatibility relief in sub-item c.

3. Expert insights

Insight 1: the threshold is not having ISO 13485 but having it issued by a body whose accreditation is recognised by MDSAP. The wording is Certificado ISO 13485 emitido por un organismo de certificación, con acreditación reconocida por MDSAP: the object of the test is the certification body, not the certificate. Before claiming the exemption, companies must verify the accreditation status of the issuing body.

Insight 2: the official text contains an inconsistent cross-reference. The NOTA refers to los requisitos del numeral 13, incisos a, b, c, d, e, f de este capítulo, yet item 13 of Chapter 6 is the sample provision and has no sub-items a to f; the sub-items belong to item 12, the product monograph. This volume reads the reference as item 12, sub-items a to f, and lists the point as a matter to confirm in writing with DDM. It is the fifth numbering issue identified in the official text.

Insight 3: the waiver covers six items, not all twelve. Even where it applies, sub-items g to l of item 12 remain due: the sterilisation or calibration validation report, analytical method validation, disposal method, technical vigilance plan, labelling and packaging, and instructions or package insert. Reading the waiver as exempting the monograph altogether will lead directly to missing documents.

Insight 4: a second relief path is hidden in sub-item c: products manufactured and marketed in countries with reference regulatory authorities (Autoridades reguladoras de referencia) are exempt from submitting biocompatibility studies. It runs in parallel with the MDSAP waiver, and because the conditions differ, the two can be claimed separately.

Insight 5: the second half of the NOTA leaves a future channel open: o según se establezca en el Lineamiento para la aplicación de las buenas prácticas de utilización de decisiones regulatorias de otras jurisdicciones en la Regulación de Medicamentos y Dispositivos Médicos en Nicaragua. The text of that guideline was not obtained for this volume, so its scope and its status in force are not presumed here.

Insight 6: MDSAP is a concept formally recognised by the standard. The list of abbreviations in Chapter 4 of NTON 24001:2023 includes MDSAP, por sus siglas en inglés. Programa de Auditoría única de Dispositivos Médicos, which shows that the waiver is part of the design of the standard rather than an incidental reference.

4. Practical recommendations

• Verify whether the issuing body’s accreditation is recognised under MDSAP before deciding to claim the exemption, since the test is applied to the body rather than the certificate.
• Draft the exemption statement against item 12, sub-items a to f, and note in it that the official NOTA cites numeral 13, asking DDM to confirm.
• Even where the exemption is claimed, prepare the six remaining sub-items from g to l: validation reports, method validation, disposal method, technical vigilance plan, labelling and packaging, and instructions.
• Assess the second path in sub-item c in parallel: products manufactured and marketed in countries with reference regulatory authorities may be exempt from biocompatibility studies.
• Track the publication status of the guideline on the use of regulatory decisions from other jurisdictions, whose text may further widen or refine the relief.
• File the ISO 13485 certificate itself under item 8 as an original or notarially certified copy, with legalisation where no verification mechanism is shown.

5. Verification checklist

• □ The accreditation of the issuing body has been checked against the MDSAP recognition condition
• □ The exemption statement has been drafted against item 12, sub-items a to f, noting the cross-reference issue in the official NOTA
• □ The six remaining monograph sub-items from g to l have been prepared
• □ The second relief path in sub-item c has been assessed, for products made and sold in countries with reference regulatory authorities
• □ Tracking of the publication status of the guideline is in place
• □ The ISO 13485 certificate has been filed under item 8, with legalisation completed where required by the NOTA

Related reading: [Electrical safety certificate: IEC, UL, CSA or equivalent](/nicaragua-medical-device-registration/electrical-safety-certificate/) | [The twelve items of the product monograph: from technical specifications to disposal](/nicaragua-medical-device-registration/product-monograph-twelve-items/) | [The five stages of registration: preliminary review, evaluation, issuance, first-import analysis and release](/nicaragua-medical-device-registration/five-stage-registration-process/)

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