Bolivia RM 010 Medical Device Registration Manual: Citation and Version Control

1. Key takeaways

The Medical Device Sanitary Registration Manual (Manual para Registro Sanitario de Dispositivos Médicos) is the operational basis for device applications in Bolivia, approved by Resolución Ministerial N° 010. In the registration procedure for imported devices, the Bolivian official procedures portal (gob.bo) lists the manual alongside Resolución Ministerial N° 0265 of May 25, 2018 as the legal basis. On the precise reference number of the manual, public information contains three citations: Resolución Ministerial N° 010, RM 0010/2006, and the internal document number of the manual, T-N-11-RM-0909. The approach taken by GRZAN is to cite RM N° 010 as the primary reference and, at the start of every project, to verify the date of the current version on the AGEMED website, treating the discrepancy in reference numbers as a mandatory verification item rather than as an established fact. This discipline costs minutes per project and prevents the scenario in which a dossier cites an instrument number that the receiving officer cannot match to the file.

The three citations usually refer to the same underlying document seen through different documents: the number printed on the manual’s own cover, the number under which it was approved, and the internal control number of the publishing office. None of them is fabricated, which is what makes the discrepancy durable in secondary sources. The operational risk is not citing the wrong number in a conversation but anchoring an SOP or a dossier index to a number that cannot be traced on the AGEMED website when a new reviewer asks for the basis of the procedure. The version date recorded next to the citation is what makes any of the three numbers usable, because it ties the reference to a concrete, dated document.

2. Legal basis

3. Expert insights

Insight one: the device manual and the medicines manual are two different documents and must not be cited interchangeably. Resolución Ministerial N° 0909 of December 7, 2005 approved the general Sanitary Registration Manual, which the official procedures portal uses for medicines procedures; devices use a separate manual approved by RM N° 010. If a consultant memorandum cites RM 0909 as the device rule, that is a sign the source material was not verified, and the rest of the memorandum should be re-checked before any of it is relied upon.

Insight two: Section 1.2 of the manual anchors it to three superior instruments. The purpose clause of the manual cites Ley N° 1737, Decreto Supremo N° 25235, and Decreto Supremo N° 26873 (the unified national supply system). This explains why a device manual touches supply system matters: Bolivia designed device registration and the public supply system inside a single institutional framework, so registration outputs feed directly into public purchasing channels.

Insight three: rules at the level of ministerial resolutions can be amended without legislative procedure. This is the institutional reason why an old manual can change abruptly. A company cannot assume that because the manual has not changed in ten years it will not change next year, and this asymmetry between the age of the text and the speed of possible amendment is exactly what a version-checking routine is designed to absorb.

Insight four: the gob.bo listing is itself a verification instrument. Because the official procedures portal lists the manual and RM N° 0265 as the legal basis of the import procedure, the portal can be used as a checkpoint: if a document cited by an advisor does not appear anywhere in the chain from the law through the decrees to the resolutions listed on the portal, the burden of proof sits with the advisor. This gives an applicant a practical test that requires no insider knowledge: every procedural requirement proposed for a Bolivian submission should be traceable to a document that the state itself publishes in connection with the procedure.

4. Practical recommendations

The three recommendations below turn citation discipline into a routine. They are intentionally lightweight: a fixed citation with a dated field in the SOP, an archive folder that pairs each downloaded PDF with its download date, and a paired download of the fee schedule. None of them adds approval time, and all three pay off at the first discrepancy, whether it is a changed fee, a moved section number, or an advisor citation that cannot be traced back to the manual.

In summary, the manual is the document that most directly shapes the content of a Bolivian device dossier, and the reference number question, while cosmetic on the surface, is a reliable indicator of how carefully a submission has been sourced. A project that can state the manual it relies on, the version date, and the exact section numbers for each requirement has already done most of the documentation work that a reviewer will test first.

1. Cite RM N° 010 in SOPs and add a version verification date field, updated before every submission.
2. Build an archive of manual versions, storing each PDF downloaded from the AGEMED website together with its download date, so that changes in provisions can be traced over time.
3. Download the current fee schedule of RM N° 0265 at the same time; the manual and the fee schedule are two documents that are used as a pair.

5. Verification checklist

• □ Has the current version of the device manual been downloaded from agemed.gob.bo with the version date recorded
• □ Do the SOPs cite RM N° 010 rather than RM N° 0909
• □ Has the current fee schedule of RM N° 0265 been obtained at the same time
• □ Can the provision citations offered by consultants or agents be traced back to specific section numbers of the manual
• □ Has the discrepancy in the manual’s reference number been listed as a pending item before project start

Regulatory information verified as of October 29, 2026.

GRZAN supports manufacturers, importers, and authorized representatives with medical device registration in Bolivia, covering dossier preparation, local entity coordination, and regulatory strategy. Contact info@grzanglobal.com for project inquiries.