Bolivia Periodic Safety Reports for Medical Devices: R.M. N° 1110 and Circular 37-2025

1. Key takeaways

The periodic safety report system in Bolivia, known as Informes Periódicos de Seguridad or IPS, is based on Resolución Ministerial N° 1110, and Circular 37-2025 continues that requirement in the document that cites the resolution. GRZAN draws two boundaries here. First, the public context of the IPS system is pharmacovigilance, and its applicability to medical devices must be confirmed with AGEMED. Second, the reporting frequency is described in public sources as periodic or on request, and no single fixed cycle figure is published. This column therefore does not offer a submit-every-X-months conclusion: where no official source for a number can be found, we do not write one. What companies can do immediately is structural rather than numerical: assemble the data inputs that any periodic safety summary would require, so that if AGEMED confirms an obligation, or a frequency, the first report can be produced from existing material instead of a retrospective data hunt.

The inputs of a periodic safety summary are largely the same regardless of jurisdiction: complaint and incident counts over the period, field corrective actions taken, changes to the product or its labeling, and volumes placed on the market. For Bolivia specifically, the market volumes come from the importer shipment records, the incident data from the vigilance files described elsewhere in this series, and the product history from the registration file. None of these sources requires new infrastructure; they require only that someone be named to collect them on a fixed cadence. GRZAN has found that the cost of a first IPS-style report, once the inputs are inventoried, is mostly editing rather than data gathering, which is precisely why building the aggregation mechanism now is cheap and retrofitting it under an authority deadline is expensive.

2. Legal basis

3. Expert insights

Insight one: the pharmacovigilance system is mature, and borrowing for devices is legally conceivable. The IPS system created by R.M. N° 1110, together with the MISA platform, forms a reasonably complete pharmacovigilance framework. Because devices were brought into the same law by Article 2 of Ley N° 1737, a legal basis for extending the system to devices exists. But the existence of a basis is not the same as a converted obligation, and the two must not be conflated. Until AGEMED states the position, the correct compliance posture is readiness without premature self-imposition: build the capability, record the open question, and avoid asserting in official documents a duty whose applicability is unsettled.

Insight two: Circular 37-2025 is a signal, not a rulebook. The circular cited R.M. N° 1110 in 2025, which shows that the IPS system is still being actively invoked and enforced in recent practice. GRZAN therefore tracks it as a regulatory monitoring item: if AGEMED later issues a device-specific vigilance or periodic reporting document, it will most likely appear first as a circular or a resolution of this kind. Companies that already follow the circular stream will see the change coming; companies that do not will learn about it from an inspector. The tracking entry should record the review date and the source checked, so that the file shows continuous attention rather than a single download at project start.

Insight three: the actionable company-side step does not depend on whether the regime is explicit. Whether or not the IPS obligation reaches devices, establishing a periodic safety data aggregation process is a low-risk, high-return action. The same aggregated dataset simultaneously serves vigilance reporting, the updating of re-registration documentation, and data consistency with the parent company abroad. One process, three uses: this is the most economical compliance investment available on this topic. It also protects the company in the interval before any authority answer arrives, because a data aggregation that exists and runs demonstrates a functioning quality system even while the legal question remains open.

4. Practical recommendations

1. Confirm the applicability and frequency of the IPS for devices with AGEMED in writing, and archive the answer so that the company position on this question is documented rather than remembered.
2. Establish an annual safety data aggregation regardless of whether it is mandatory, under the practical estimate used by GRZAN, producing a reusable report draft with defined data sources, cut-off dates, and sign-off.
3. Place Circular 37-2025 on the quarterly regulatory tracking list, watching for any device-specific successor document, and record the review outcome even when nothing has changed.

A minimal annual aggregation can be assembled in a single template: one page of market volumes by product, one page of complaints and incidents with outcomes, one page of field actions and labeling changes, and a closing statement of data sources and cut-off date. The template is shared with the parent company so that the Bolivian content slots into the global safety summary without translation of structure, only of content. GRZAN keeps such a template in every Bolivia project file, because it turns the open legal question into a standing readiness item, and because the moment AGEMED answers the applicability question, the company can move from readiness to submission within days rather than months.

5. Verification checklist

• □ Have the official texts of R.M. N° 1110 and Circular 37-2025 been obtained?
• □ Has the applicability of the IPS to devices been confirmed with AGEMED in writing?
• □ Has the reporting frequency been confirmed, with no specific cycle written into the SOP if no official figure exists?
• □ Has a periodic safety data aggregation process been established?
• □ Has this topic been added to the quarterly regulatory tracking list?

Regulatory information verified as of October 29, 2026.

GRZAN supports medical device manufacturers, importers, and authorized representatives with sanitary registration, periodic safety documentation, and post-market compliance in Bolivia. For assistance with this topic, contact info@grzanglobal.com.