Nicaragua medical device regulations

Signed 15 June 2026, this ANRS/CONEA resolution and its annex contents govern imports and associated activities involving X-ray generators and linear accelerators. Medical-use requirements and radiotherapy additions are retained alongside their necessary common procedures and explicit nonmedical boundaries. Two working days concern document review, fifteen working days concern correction, and two months concern import-authorisation validity; these do not establish a total approval deadline or a product-registration term. The source requires fee payment without supplying an amount. Original duplicate numbering and source wording are preserved. Later amendments and its interaction with general ANRS import rules remain unverified.

Official 25 March 2026 circular ends the transitional arrangements in Articles 12 and 13 of Annex I to Resolution 0020/2025. All establishments must submit device imports through VUCEN from 13 April 2026.

Complete resolution and Annex I governing representation, responsible professionals, import/distribution/commercialisation authorisations, renewals, substitutions and revocations, expressly including medical devices. Signed 5 February 2026 and effective on signature; expressly repeals Resolution 0031/2024.

Signed 2 October 2025 and effective 13 October, this complete resolution includes Annexes I and II and the VUCEN import workflow. The subsequent March 2026 circular ends specified transitional provisions from 13 April 2026; the resolution is not presented as an untouched consolidated text.

Complete resolution with annexed licensing and registration procedures, including renewals and post-registration changes. Effective 2 May 2025; repeals Resolution 003/2023, Resolution 0008/2024 and Resolution 003/2021 insofar as device establishment licensing is concerned.

Historical complete 2024 procedure, effective 4 November 2024. Expressly repealed by Resolution 0001/2026; retained for traceability and excluded from current-rule discovery.

Complete 69-page resolution and annexes update and replace Resolution 0009/2024 and specified import circulars. Medical-device import/export provisions must also be read with Resolution 0020/2025 and the 2026 VUCEN circular. The original contains both operative rules and forms; no later consolidation is implied.

Complete resolution and annex on authorisation of training, product launches, scientific meetings and promotion of pharmaceutical products, medical equipment and instruments. Signed 9 August and effective 12 August 2024.

Complete resolution and annexed appointment procedure effective 1 August 2024. Expressly repeals the 2018 device consultations circular and 2021 device advance-appointment circular, together with the specified rejection-consultation arrangements.

Complete ANRS resolution and attached procedure governing regulatory rulemaking, consultation, impact assessment and normative powers across ANRS product areas, including devices. Signed and effective 1 April 2024.

Complete official enactment packet including the signed 7 July 2023 Ministerial Resolution 347-2023, current-at-issue fee tables and device services. Repeals Resolution 121-2007. The resolution number was checked against the scanned heading because OCR misreads it as 547.

Complete official 26 May 2023 circular changes device registration certificate format and allows five working days after certificate collection to request corrections. Later requests require the post-registration-change fee; ANRS determines whether correction proceeds within ten working days. Original includes the signature and distribution list.

Complete official circular signed 11 August 2022 removes separate payment orders, allows direct payment at MINSA central cashier and sets a six-month receipt validity. The 2024 online-payment circular adds electronic and bank options and explicitly retains the central-cashier option; this earlier original is preserved with that later context.

Complete eleven-article law from the National Assembly legal database, including promulgation and the official annotation that it is included in the Health Legal Digest register of laws in force. Establishes ANRS and its device, medical technology, authorisation, inspection, vigilance and fee responsibilities. The original government site is accessible on its published HTTP endpoint; an unavailable HTTPS request was not substituted with a secondary summary.

Complete Ministry of Health approving agreement and attached standard for establishments manufacturing, importing, exporting, storing, distributing and commercialising medical supplies, including devices. The first two pages are scanned approval and signature pages; signed and effective 4 February 2020.

Official ANRS appointment request and attachment-list template, used by departments including the medical-device directorate. Records the applicant, represented establishment, contact details, requested department and purpose. Refers to Administrative Resolution 0014/2024 for appointment procedures.

Complete eleven-page ANRS user guide approved 23 September 2024 for obtaining a medical-device classification statement, including requirements, steps and document-control history. It remains listed in the official device catalogue; no later consolidation is inferred.

Official resolution requires lead disc or equivalent shielding for pistol/camera type dental X-ray units, restricts their use to field applications and requires periodic reporting using the attached Annex I form. The complete five-page original includes the report table.

Official 25-page requirements document issued 6 January 2022 and updated 13 January 2023. Includes manufacturing and distributor requirements, regency, technical service and changes to address, warehouses, legal representative, responsible professional and product categories after licensing. Read with the later 2025 KARPLUS procedural resolution; this source is not a consolidation of later rules.

Complete signed 9 August 2024 resolution and annex governing circumstances in which the usual registration process cannot be followed, including medical devices. The authoritative scan is retained with its original forms and conditions.

Official resolution signed 4 November 2024, including Annex I on use of external expert committees in ANRS regulatory assessment. Its product scope includes medical devices.

Official ANRS application for a medical-device free-sale certificate. Requests the sanitary professional, device and registration details, destination country, manufacturer and manufacturing licence, with applicant and ANRS signature fields.

Official consolidated expression approved in the Health Legal Digest, published in La Gaceta 2 of 9 January 2024, printed pages 174–203. Includes Article 62 device regulation, sanctions, administrative powers, original promulgation and the seven-item consolidation note. Consolidated through 27 September 2023; later currentness review is separate from that legal consolidation date.

Complete official 452-article consolidated regulation from the Health Legal Digest, La Gaceta 2 of 9 January 2024, printed pages 344–440. Includes device registration, import/export, distribution and commercialisation in Articles 313–321, inspections, administrative measures and all ten amendments identified in the consolidation note. Consolidated through 27 September 2023; no claim of a later consolidated date is made.

Official ANRS KARPLUS account application and completion instructions, expressly including the medical-device directorate. Covers existing users, professional roles and establishment information, with instructions for applicants to whom specified fields do not apply.