Paraguay Medical Device Review Timelines: 45, 120, 60 and 30 Working Days Explained

1. Key takeaways

1. Evaluation timeframes (Article 9): the simplified registration procedure runs on 45 working days; the integral analysis runs on 120 working days. These figures bind the regulator and measure the evaluation itself.
2. Deficiency correction timeframes (Article 9): inconsistencies or defects must be remedied within 60 working days counted from the working day following the notification; where the reply brings new information not previously covered and problems arise again, a further 30 working days are granted.
3. Consequences of missing the deadline: where the correction is not completed within the timeframe, or where the technical evaluation is unsatisfactory, the outcome is the denial of the application (denegación del trámite).
4. Class II post-market changes (Article 14): DINAVISA evaluates these within 45 working days, and the same 60 / 30 working day correction rule applies, so the change clock behaves like a second evaluation clock running alongside the initial registration.

2. Legal basis

Section 1 of the operational instructions makes the timeframes of the resolution binding on the applicant’s conduct of the procedure, which is why the correction clocks deserve the same scheduling discipline as the evaluation clocks. The statutory figures are few and fixed: 45 and 120 working days for evaluation, 60 and 30 working days for corrections, 45 working days for Class II changes, and the reapplication rule of Article 26 after denial. Everything a project promises internally or externally should be traceable to this set of numbers or expressly labeled as something other than a statutory figure, so that no reader mistakes a planning assumption for an entitlement created by the resolution.

Two features of the counting deserve emphasis. First, all four figures are expressed in working days, not calendar days, so calendar throughput shrinks around public holidays and the office calendar of the authority, and a 45 working day evaluation can span considerably more calendar time than a naive conversion suggests. Second, the clocks measure different actors: no extension of the 60 working day correction window is available on the applicant’s initiative, while the evaluation clocks bind the authority only within their own scope. Planning therefore treats the four figures as fixed reference points and places every other expectation, including translation, notarization and internal approvals, outside the statutory numbers, expressly labeled as a practical estimate rather than as a period drawn from Article 9, so that no reader mistakes a planning assumption for a statutory entitlement.

3. Expert insights

Insight one: four numbers form a complete clock system, and each clock starts at a different point. The 45 and 120 working day figures constrain the regulator and start at acceptance or entry into evaluation; the 60 and 30 working day figures constrain the applicant and start on the working day after the notification. Adding the four figures together produces a wrong schedule: correction periods are generally not counted within the continuous running of the evaluation clock, so the actual elapsed time will be longer. This scheduling observation is offered as a practical estimate based on the structure of the provisions, not as a statutory rule, and it should be applied with a margin.

Insight two: the 30 working day figure is a second-correction trap. It is triggered only where the reply brings new information not previously covered and problems arise again. In other words, if the company answers within the 60 working day window in one round, completely, and without introducing new variables, the second round never opens. The correction strategy should therefore be minimum necessary plus all at once, not phased submissions that keep the file alive and expose the project to a second clock, a second round of review and a second opportunity for findings.

Insight three: denial is not the end of the road, but it requires paying again. Article 26 provides that after an application is denied, the interested party may reapply under the procedure and pay the corresponding fee again. The cost of losing control of the timeframes is therefore time plus a second fee, not the loss of eligibility to seek authorization altogether. That is a real but bounded sanction, which means the financial model of every project should carry a contingency line for a resubmission scenario rather than assuming a single uninterrupted run to approval.

4. Practical recommendations

1. Maintain a four-clock schedule: the evaluation clock (45/120), the correction clock (60), the second-correction clock (30) and the change clock (45), each with its own start date recorded in the project tracker so that no clock is discovered late.
2. Apply the all-at-once principle to deficiency replies, and do not introduce information unrelated to the original application in the answer; every new document is a new review surface.
3. Include in the budget the second fee and the time cost of resubmitting after a denial under Article 26, and treat the contingency as a planning assumption rather than an admission of failure.
4. In external commitments, quote only the statutory figures above and do not add self-estimated cycles; where a cycle expectation must be given to a client, label it expressly as a practical estimate so that no statutory basis is implied.

5. Verification checklist

• □ Schedule distinguishes the evaluation clock from the correction clocks, with start dates recorded
• □ Deficiency replies follow the all-at-once principle, without unrelated new information
• □ Second fee budgeted (Article 26) with a resubmission contingency in the plan
• □ External commitments quote only the four statutory figures 45/120/60/30
• □ Non-statutory cycle estimates labeled as practical estimates in all client-facing documents

Regulatory information verified as of October 29, 2026.

GRZAN provides registration support for manufacturers, importers and authorized representatives in Paraguay, covering timeline planning, deficiency response strategy, change management and resubmission handling under Resolución DINAVISA N° 226/2024. Contact: info@grzanglobal.com