The Karplus System: Accounts, Modules and User Rules

1. Key takeaways

In Nicaragua, all device sanitary licence and sanitary registration procedures are handled online through ANRS’s Karplus system. The first operative article of RA 0007/2025 uses the words «totalmente en línea» — entirely online. Accounts must be applied for in advance: a health professional sends the official application form to dismed@minsa.gob.ni, and after review the DDM activates the device module for professionals who already hold a Karplus account, or creates a new account and issues a temporary password for those who do not (Annex I, Article 6). Three hard constraints are written in Annex I, Article 5: accounts must not be lent to third parties (item i), each declarant may submit at most 5 applications per day (item l), and no new application may be filed for the same registration or establishment while one is already in progress (item m). The system is open only on working days from 8:00 to 17:00 (item n).

2. Legal basis

The rules governing the Karplus channel, account applications and system availability all come from Administrative Resolution No. 0007/2025 and its Annex I. The key provisions are summarised below.

3. Expert insights

Insight 1: the first operative article says «totalmente en línea» — not encouraged online, but a full migration. QUINTO of the same resolution repeals RA 003/2023, RA 0008/2024 and the device-licence parts of RA 003/2021, so the three old procedures no longer run in parallel with it. How in-progress applications filed during the transition carry over is not addressed in the text, and this volume makes no presumption about it.

Insight 2: account eligibility attaches to the person, not the company. Annex I, Article 5, items f and g require the account to be held personally by a regente sanitario or an authorized registrador, and the official application form in Annex II requires the código sanitario issued by ANRS. Replacing the declarant therefore means replacing the account holder — it is not a change of contact person.

Insight 3: the fully online rule has one exception, and it is a unilateral discretion of the DDM. Annex I, Article 5, item c preserves the DDM’s power to require submission of paper originals, and an identical note appears before Article 7 and Article 11 of Annex I. Originals are returned after verification. This is not a submission option the applicant may choose; companies must still keep originals available for immediate retrieval.

Insight 4: deadlines stack on top of system opening hours. Item n of Article 5 restricts system availability to working days from 8:00 to 17:00, and item o requires corrections after a rejection to be completed within that window. Correction periods are counted in working days, and the practically usable window is narrower still — cross-timezone teams in particular need to convert the hours.

Insight 5: of the three hard constraints, item m is the most easily misread as one matter per day. It restricts applications related to the same registration or establishment — «relacionado con ese registro sanitario o establecimiento». Registrations for different products may still be filed in parallel on the same day, as long as the cap of 5 applications is respected.

Insight 6: responsibility for the account is strict liability. Item i states that the holder «es responsable de cualquier acción que se realice mediante la utilización de su usuario Karplus» — responsible for any action carried out through the use of the Karplus account. Together with the daily quota in item l, this sets a hard ceiling on filing cadence. Account handovers and departures therefore need a documented trail, not merely the return of a password.

Insight 7: item h of Article 5 indicates that accounts are reused across modules: professionals who already hold a Karplus account with modules of other directorates of ANRS must say so when applying. The same person may hold both a pharmaceutical and a device module. Whether the 5-application quota is aggregated across modules is not stated in the text — this volume treats it as not stated and recommends written confirmation from the DDM.

4. Practical recommendations

• Settle the account holder first: identify which regente sanitario or registrador holding a código sanitario will apply by name, and send the current Annex II application form to dismed@minsa.gob.ni.
• After the account is approved, change the temporary password immediately and verify the permissions, confirming that the activated module is the device module and not one of another directorate (Annex I, Article 6, item 6).
• Plan the filing cadence around 5 applications per person per day: do not file a new application for the same registration or establishment while one is in progress; different products may run in parallel subject to the cap of 5.
• Do not simply wait out a system failure: under item r of Article 5, notify by email with screenshots of the error and keep the transmission records as the evidentiary basis for any deadline defence.
• Keep originals retrievable at all times: even though everything runs online, maintain an archive of paper originals that can be submitted on demand under item c of Article 5.
• Maintain an account ledger: record the holder, the código sanitario, the activated modules and handover records, in line with the strict-liability requirement of item i.

5. Verification checklist

• □ Identified the account applicant and sent the current Annex II application form to dismed@minsa.gob.ni
• □ Obtained the Karplus account with device module access and completed the first password change
• □ Verified the filing quota: no more than 5 applications per day, with no application in progress for the same registration or establishment
• □ Confirmed the system operating window of working days 8:00 to 17:00 and converted correction windows into local working hours
• □ Prepared an archive of paper originals that can be submitted for verification on DDM request (Annex I, Article 5, item c)
• □ Established a ledger of account holders and handover records meeting the attribution requirement of Article 5, item i

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