Category: First-in-Human

The protocol question I get most from first-in-human device teams isn’t about endpoints. It’s this: after the first patient, what has to happen before we treat the second one? Ethics committees in Latin America ask the same thing, usually in the first review letter. If the protocol answers it with “per investigator judgment”, expect a query.

I am Julio Martinez-Clark, CEO of bioaccess®. This page sets out how I write stopping rules, staggered enrollment and safety oversight into a first-in-human (FIH) or early feasibility device protocol, using what the FDA guidance, 21 CFR Part 812 and Brazil’s ANVISA RDC 837/2023 actually say. It sits next to our early feasibility studies page, the FIH protocol template and the FIH basics article. This is operator guidance, not legal advice.

One-sentence answer

A defensible FIH device protocol enrolls a small sentinel group one subject at a time, names the event types that pause enrollment, gives a named reviewer (a medical monitor, safety committee or data monitoring committee) the decision to resume, and maps every pause to the reporting clocks of each regulator involved: 10 working days for unanticipated adverse device effects under 21 CFR 812.150, and 24 hours from investigator to sponsor plus 7 or 15 calendar days to ANVISA under RDC 837/2023.

What FDA’s early feasibility guidance says

FDA’s guidance on investigational device exemptions for early feasibility studies, issued 1 October 2013, is still the clearest public text on this. Section 7.1 lists risk-mitigation measures FDA expects to see weighed against the uncertainty of an early device. The list reads like a protocol checklist:

• sites with the expertise to manage the adverse events you anticipate;
• investigators who are qualified and trained on the device;
• limiting the number of subjects, with 5 to 10 initial subjects given as an example;
• more frequent follow-up than standard care;
• timely reporting of serious adverse events, after each occurrence;
• non-sequential enrollment, for example treating patients with more favorable anatomy first;
• a pre-specified plan for assessing outcomes before enrolling more patients, which can be as frequent as after each use.

Section 7.3.2 adds the IRB side. Reviewing boards may look at an early study more often than once a year, review after a small target number of subjects, or use graduated enrollment based on a safety analysis of the preceding subjects. Section 7.4.2 says a data monitoring committee of clinicians, scientific experts and people with ethics expertise can serve as a risk-mitigation element. The guidance’s Appendix 4 example describes up to 10 subjects at up to 3 sites, with each subject evaluated before the next is enrolled.

None of that is binding, and FDA says so. But when a US reviewer later looks at your Latin American FIH data, this is the yardstick in their head.

The binding clocks in 21 CFR Part 812

If the study runs under an IDE, or you want the data to support a US submission, three provisions shape the stopping rule:

• Definition (812.3(s)). An unanticipated adverse device effect (UADE) is a serious effect on health or safety, a life-threatening problem or a death caused by or associated with the device, if it wasn’t identified in nature, severity or incidence in the investigational plan, or any other unanticipated serious problem tied to the device that relates to subjects’ rights, safety or welfare.
• Reporting (812.150). The investigator reports a UADE to the sponsor and the reviewing IRB as soon as possible and no later than 10 working days after first learning of it. The sponsor reports the results of its evaluation to FDA, all reviewing IRBs and participating investigators within 10 working days after first receiving notice.
• Evaluation and termination (812.46(b) and (c)). The sponsor evaluates a UADE immediately. If it presents an unreasonable risk to subjects, the sponsor terminates all investigations, or the parts that carry the risk, as soon as possible and no later than 5 working days after making that determination and no later than 15 working days after first receiving notice. For a significant-risk device, resuming needs IRB and FDA approval.

For studies outside the United States, 21 CFR 812.28 lets FDA accept the data if the investigation is well designed, well conducted and follows good clinical practice, including independent ethics committee review. Writing the stopping logic to the Part 812 standard costs nothing at the protocol stage and removes an argument later.

What Brazil adds under RDC 837/2023

ANVISA’s RDC 837 of 13 December 2023 governs device clinical investigations in Brazil. It is more specific than most sponsors expect:

• Data monitoring committee (Art. 57). Before the study starts, the sponsor considers a DMC based on its risk analysis of the device and of study participation. Pivotal studies of Class III and IV devices must have one, and its recommendations go to ANVISA as an amendment (aditamento) within 30 calendar days. The DMC’s functions belong in the clinical investigation plan, and if you decide not to set one up, the plan has to justify that.
• Aggregate review (Art. 54). The sponsor, or an independent DMC, evaluates adverse events in aggregate, and that evaluation feeds the annual reports.
• Investigator to sponsor (Art. 62). Serious adverse events and deaths reach the sponsor within 24 hours.
• Sponsor to ANVISA (Arts. 63 and 64). Unexpected serious events in Brazil that are fatal or life-threatening, with possible, probable or definite causality to the device, go to ANVISA within 7 calendar days of the sponsor learning of them, with follow-up information added within 8 calendar days. All other unexpected serious events with that causality go within 15 calendar days.
• Pauses (Arts. 24 and 26). A temporary suspension taken as an immediate safety measure is notified within 7 calendar days. A sponsor decision to suspend or cancel the study, with its justification and follow-up plan for enrolled subjects, is notified within 15 calendar days.
• Restart (Art. 27). Reactivating a suspended study is a secondary petition to ANVISA, and the study restarts only after ANVISA approval is published in the Diário Oficial da União.

ANVISA’s adverse-event manual for device trials (2nd edition, 13 November 2024) explains the NotivisaEC form and uses the WHO-UMC causality categories. Use the same categories in your protocol so the investigator’s causality call maps straight onto the form. For the wider submission picture, see our ANVISA device clinical trial submission guide. If your sites are in Argentina, the clocks differ; see adverse event reporting to ANMAT in FIH trials.

How I write the stopping rule

A stopping rule that works has five parts. I write each one as a sentence the site coordinator can follow at 2 a.m.

1. Sentinel cohort. Name the number of subjects treated one at a time. Use the guidance’s 5-to-10 range as a reference, not a target. The right number depends on how fast the device’s failure modes show up.
2. Observation window. State how long each sentinel subject is followed before the next is treated, and why. The window comes from the device’s mechanism and the acute risk profile in your risk analysis, not from a template.
3. Pause triggers. List them as event types, not judgment calls. Any UADE, any device-related death, any unexpected serious device effect, and any device malfunction that could have caused serious harm. Add device-specific triggers from the risk file, such as migration, embolization or loss of function.
4. Who decides. Name the reviewer and say what they see. For a small single-country FIH study, an independent medical monitor or safety committee may be enough. Where Art. 57 applies, or the risk analysis points to it, a DMC with a written charter. Investigators and sponsor employees don’t vote on their own restart.
5. Restart conditions. Say what evidence ends the pause: root-cause analysis, a protocol or IFU change if needed, ethics committee notification and, where a regulator requires it, agency approval before the next subject. In Brazil that means the Art. 27 reactivation petition.

Non-sequential enrollment is a design choice

The guidance’s suggestion to treat favorable anatomy first is easy to miss. In practice it means the first subjects are the ones in whom a failure is most likely to be the device’s fault, not the patient’s. Write the sentinel-cohort inclusion criteria tighter than the expansion cohort, and say so in the protocol. Committees read that as a sponsor thinking about subject safety, and it makes the first safety review easier to interpret.

Common mistakes I see

• Stopping rules written as “the sponsor may pause enrollment” with no triggers.
• A DMC charter that exists on paper but meets only after the last subject.
• Causality scales in the protocol that don’t match the regulator’s form.
• One reporting clock in the protocol when the study runs in two countries with different clocks.
• No plan for subjects already treated when the study pauses, which RDC 837 Art. 24 asks for.

How bioaccess® runs this

bioaccess® designs the safety-oversight section with the sponsor’s medical and clinical team: sentinel cohort, pause triggers, the reviewer and its charter, and a single reporting matrix that covers every country in the study. We set up independent safety reviewers, run the investigator-to-sponsor-to-agency chain and file pause and restart notices with ethics committees and regulators. Study scope and pricing are set at proposal. Start on our early feasibility studies page or clinical trials in Brazil, or book a call.

Operator checklist

1. Write the sentinel cohort size and the observation window, with the reason for each.
2. List pause triggers as event types drawn from 812.3(s) and your risk file.
3. Name the reviewer who decides restarts and what data they see.
4. Decide on a DMC against RDC 837 Art. 57, and justify it in the plan if you don’t set one up.
5. Build one reporting matrix: 24 hours site to sponsor, 7 and 15 calendar days to ANVISA, 10 working days under 812.150.
6. Use WHO-UMC causality categories so site calls map onto NotivisaEC.
7. Write the follow-up plan for treated subjects before you need it.

Sponsors budget months for the technical file and then lose weeks on a stamp. Almost every Latin American device regulator wants foreign documents (the certificate of free sale, the manufacturer’s power of attorney, the CE or quality-system certificate) authenticated before it will read them. Whether that means an apostille or a trip through a consulate is a question you can answer in an afternoon, if you know where to look.

I am Julio Martinez-Clark, CEO of bioaccess®. This page explains how the 1961 Hague Apostille Convention applies to medical device registration across Latin America, and what each regulator’s own rule adds on top. It sits alongside our LATAM market-access hub and the country registration guides linked below. This is operator guidance, not legal advice.

One-sentence answer

All 19 countries this guide covers (Mexico, Central America including Belize, the Dominican Republic, and South America from Colombia and Venezuela to Argentina and Chile) are Contracting Parties to the Hague Convention Abolishing the Requirement of Legalisation for Foreign Public Documents (HCCH status table, last updated 30 June 2026). For a public document issued in another Contracting State, including the United States, EU member states, China (in force 7 November 2023) and Canada (in force 11 January 2024), a single apostille from the issuing country replaces consular legalization. The destination regulator’s own rule still decides which documents need it and in what language.

What the Convention actually does

• It replaces legalization, not translation (Articles 2 and 3). Legalization means the destination country’s diplomatic or consular agent certifying the signature, the signer’s capacity and the seal. Between Contracting States, the only formality that may be required is the apostille, issued by the competent authority of the State where the document comes from.
• It certifies the signature, not the content (Article 5). An apostille confirms who signed and in what capacity. It says nothing about whether your device is safe or your certificate is current.
• It covers public documents (Article 1). These are court documents, administrative documents, notarial acts, and official certificates placed on private documents, such as a notary’s certification of a signature. It does not cover documents executed by diplomatic or consular agents, or administrative documents dealing directly with commercial or customs operations.
• Each State names its own issuing authorities (Article 6). The HCCH publishes the list for every Contracting Party.

The practical consequence: a certificate issued by a health authority is an administrative document and can be apostilled directly. A manufacturer’s letter of authorization, power of attorney or sworn declaration is a private document. It has to be notarized first, and the apostille goes on the notarial certificate. Certificates from private certification bodies follow the same notarize-then-apostille route unless the destination regulator says otherwise.

Check the objection column before you rely on it

Article 12 says an accession only takes effect between the acceding State and the Contracting States that did not object within six months. The HCCH status table flags these cases. For example, China’s accession drew an objection from India, so the Convention does not run between those two, while it does run between China and the Latin American parties. China also declared that the Convention does not apply between China and Contracting States it does not recognize as sovereign. If you are filing a Chinese document in a country without diplomatic relations with Beijing, confirm acceptance with the regulator before you rely on the apostille.

This matters more than it used to. We regularly get registration requests from manufacturers in mainland China. Before November 2023, their certificates had to go through consular legalization. Today the apostille route is open for most Latin American destinations.

What the regulators ask for

The Convention removes the consulate step. It doesn’t change the regulator’s checklist. Here is what the device rules we have read in primary text say.

Colombia (INVIMA)

Article 44 of Decreto 4725 de 2005: foreign documents that correspond to official information must be authenticated by the Colombian consul and the Ministry of Foreign Affairs or, where applicable, carry an apostille. Documents not in Spanish need an official translation. If a document states no validity, it’s treated as valid for one year. That one-year default catches teams who apostille a certificate of free sale early and then wait on the rest of the file. See our INVIMA registration guide.

Nicaragua (MINSA/ANRS)

NTON 24001:2023 requires the local legal representative’s power from the manufacturer to be apostilled or, failing that, consularized and legalized. The FDA certificate (for US-made products) or the certificate from the authority of the country of manufacture must be in original or a notarized copy, in Spanish or with a notarized translation, and apostilled or consularized and legalized. The same applies to CE certificates for EU manufacturers. A certificate of conformity with no verification mechanism must also be apostilled or consularized. See our Nicaragua guide.

Honduras (ARSA)

Acuerdo 0631-ARSA-2023 repeats the same instruction across its requirement lists. A document issued abroad must be apostilled or authenticated. If the registrant is a Honduran company, the document is presented as a photocopy with its certificate of authenticity. See our Honduras guide.

Paraguay (DINAVISA)

Resolución DINAVISA 226/2024: every foreign legal document must be consularized and legalized, or apostilled, and translated into Spanish by a public translator registered with Paraguay’s Supreme Court. DINAVISA’s filing instructions add that each document goes in with its translation and apostille or legalization stamps in a single file. The contractual relationship between manufacturer and marketer also has to be apostilled or consularized. See our Paraguay guide.

Bolivia (AGEMED)

AGEMED’s device manual asks for the certificate of free sale to be legalized by the Bolivian consulate, or certified by Bolivia’s Ministry of Foreign Affairs where there is no consulate. The quality-system certificate needs a copy legalized by the health authority, not necessarily consularized, and the legal-representation document doesn’t need consularization. The manual predates Bolivia’s accession to the Convention (in force 7 May 2018), so confirm with AGEMED how its evaluators apply the apostille. See our Bolivia guide.

For the larger markets (ANVISA, COFEPRIS, ANMAT and the others in our hub), check the current agency instruction for each document type before you send anything for apostille. Rules on which documents need it, and whether a sworn translation must follow, differ by document.

The order of operations

1. List every foreign document the destination rule names: certificate of free sale or FDA certificate, power of attorney or letter of authorization, CE or quality-system certificate, manufacturing contracts, declarations.
2. Sort them into public and private. Health-authority certificates are public. Manufacturer letters and declarations are private and need a notary first.
3. Get the apostille in the issuing country, from the authority that country designated under Article 6. A document notarized in one country can’t be apostilled in another.
4. Translate in the destination country when the rule requires an official or sworn translator, as Colombia, Nicaragua and Paraguay do. Have the translator cover the apostille as well.
5. Track validity from the issue date. Colombia defaults to one year, and Paraguay and Bolivia accept a certificate that states no validity for two years. Schedule apostilles so the documents are still valid when the agency reviews them, not just when you file.
6. Use consular legalization only when the Convention doesn’t apply: when the issuing country isn’t a Contracting Party, an objection blocks the pair, or the document falls outside Article 1.

Where this fits in a registration

Legalization is rarely why a registration fails, but it’s often why one starts late. A missing apostille on a power of attorney means an observation and a correction round in Paraguay, and an expired certificate of free sale in Colombia means a new round trip to the issuing country. Build the legalization plan in the first week, at the same time as the technical file. Our certificate of free sale post covers the earlier problem: devices that don’t yet have a home-country authorization to certify.

How bioaccess® handles it

Every registration bioaccess® processes starts with a document map: which foreign documents the destination rule names, which need a notary, where each apostille comes from, and which translator signs the Spanish version. The bioaccess® fixed-price market-access subscription covers only multi-importer countries plus Argentina. Other countries are quoted as scoped, manufacturer-funded processing. Details: bioaccessla.com/market-access.

Operator checklist

1. Confirm on the HCCH status table that both the issuing and destination countries are parties, and check for objections.
2. Notarize private documents before you send them for apostille.
3. Apostille in the country where the document was issued or notarized.
4. Book sworn or official translators in the destination country early.
5. Calendar validity: one year by default in Colombia, two years in Paraguay and Bolivia.
6. Keep the original apostilled documents. Several regulators want originals or notarized copies, not scans.

When a manufacturer asks me about Bolivia, the first surprise is how old the rulebook is. AGEMED still runs device registration on a manual written when the regulator was called DINAMED, and Bolivia’s official procedures portal cites that manual today as the legal basis for the filing. The second surprise is in Section 3.2.1 of that manual: the registration certificate doesn’t necessarily belong to the company that files it.

I am Julio Martinez-Clark, CEO of bioaccess®. This page explains how to get a device that is already FDA-cleared or CE-marked onto the Bolivian market through the Agencia Estatal de Medicamentos y Tecnologías en Salud (AGEMED). It sits alongside our LATAM market-access hub, the Bolivia AGEMED country page and the Importer of Record guide. If you are planning a first-in-human study in Bolivia rather than a launch, start with our Bolivia CRO page. This is operator guidance, not a quote and not legal advice.

One-sentence answer

Bolivia registers medical devices under Ley 1737 (Ley del Medicamento, 17 December 1996), its regulation Decreto Supremo 25235 (30 November 1998) and AGEMED’s Manual para Registro Sanitario de Dispositivos Médicos. A Bolivian company authorized by Resolución Ministerial files Form 027 through AGEMED’s virtual procedure, with one registration per device group, a 30-business-day issuance target and five-year validity.

The rule that governs the file

The manual’s objective (Section 1.2) ties it to Ley 1737, DS 25235 and Decreto Supremo 26873 (the Sistema Nacional Único de Suministro). On Bolivia’s official procedures portal, gob.bo, procedure 82 (registration of an imported medical device) lists its legal basis as Resolución Ministerial 0265 of 25 May 2018 and the device manual approved by Resolución Ministerial 010. It is a virtual procedure with AGEMED as the responsible agency.

One citation detail matters if you are writing an SOP. Resolución Ministerial 0909 of 7 December 2005 approved the general Manual para Registro Sanitario, which gob.bo uses for medicines. The device manual is a separate document. If your consultant memo cites RM 0909 as the device rule, ask them to check it.

Classification follows GHTF rules

Section 1.7 sets four risk classes: I (low), IIa (low-moderate), IIb (high-moderate) and III (high). Section 1.7.2 says Bolivia recognizes the Global Harmonization Task Force classification rules and reproduces all 16 of them, covering non-invasive, invasive and active devices plus the special rules for medicinal substances, tissues, disinfection and contraception. When more than one rule applies, the highest class wins (1.7.1 d). The manual also lets AGEMED reclassify a device based on post-market experience.

You declare the class yourself. Item 2.4.7 says that if the class isn’t on your certificate of free sale, you state the class the manufacturer assigned.

One registration per group

Chapter II opens with a rule many foreign teams miss: devices are registered by group, one registration per group, using the grouping in Annex 2. Annex 2 splits devices into non-invasive, invasive and active families, then numbered groups within each (for example, osteosynthesis implants and joint prostheses together in one invasive group). Section 5.10.2 lets you add items to an existing registration as a rectification, but only if they share the same risk class and group. Map your catalogue to Annex 2 before you count how many filings you need.

Who can file

The applicant is a Bolivian establishment, not the foreign manufacturer. The file needs:

• A copy of the Resolución Ministerial authorizing the company to operate (2.2.1).
• A current Certificado de Empresa confirming its license, annual re-registration and annual inspection, whether it’s a manufacturer or an importer (2.2.2). Section 5.7.2 requires every company to re-register each year by 31 December.
• Form 027, signed by the company’s legal representative and by its regente or technical responsible person. The manual lists the professions that can act as technical responsible, from pharmacist to biomedical, electronic or mechanical engineer (2.1).
• A signed sheet naming who granted the legal representation and until when, the product owner or licensor, the manufacturer and every plant that makes, fills or packs the finished product (2.2.3).

The manufacturer’s representation document isn’t refiled with every dossier. Section 2.3.4 says it is lodged beforehand, in original, with AGEMED’s vigilance and control area, and that it doesn’t need consularization.

Who owns the registration

Section 3.2.1 is the most important paragraph in the manual for a foreign manufacturer. It says the registration certificate does not necessarily belong to the company that processes it; it belongs to whoever holds the product license, or to its manufacturer.

That gives you a starting point in negotiations, not a guarantee. Your Bolivian importer still holds the operating license, signs Form 027 and appears on the file. Put the ownership language from 3.2.1 into your distribution agreement, together with an obligation to cooperate on any change of company. Have local counsel review it before the first filing.

What an imported device has to file

• Quality-system certificate (2.3.1). GMP or an equivalent quality-system certificate, in original or a copy legalized by the health authority (the manual says not necessarily consularized). You need one for every plant, including packaging plants, and it must be no more than two years old. AGEMED can still inspect the plant or ask your home regulator about it.
• Certificate of free sale (2.3.2). It must be issued or endorsed by the national health authority of the country of origin and legalized by the Bolivian consulate. Where there is no Bolivian consulate, you present the original with a certification from Bolivia’s Ministry of Foreign Affairs. If the certificate states no validity, it’s accepted for two years from issuance. Bolivia joined the Hague Apostille Convention on 7 May 2018, after this text was written, so confirm with AGEMED whether an apostille is accepted in place of consular legalization for your document. Our certificate of free sale post explains why devices that are not yet cleared at home stall here.
• Technical file (2.4). Parts and components, a certificate of analysis or design verification and validation report, shelf life, storage conditions, an international nomenclature code (ECRI, GMDN or equivalent), lot coding, risk class, instructions-for-use summary, sterilization method and disposal method.
• Clinical evidence (2.4.8). For high-moderate and high-risk devices, particularly new products, the file includes clinical studies supporting safety and efficacy.
• Labels (2.5). Multilingual labels are accepted if one language is Spanish. Minimum content is product name, lot or serial number, expiry where applicable, manufacturer and special warnings. Under Article 149 of DS 25235, every package also carries a sticker, stamp or print identifying the Bolivian company that sells it, and the file includes its design.
• Manuals (2.7). Operating, maintenance and installation manuals must be in Spanish.
• Samples (2.6). Samples are required only for low-risk devices. For the other classes, AGEMED can verify product at the company’s warehouse at any time.

Biomedical equipment has an extra declaration (2.9). The manufacturer or Bolivian representative states that the equipment is not experimental, that spare parts and maintenance are available for five years (or the equipment’s life, if shorter), that training is offered, and that manuals are supplied in the original language and Spanish. The holder also reports installed units and their locations every year.

How the review runs

Chapter III sets the sequence: pay the service fee, get the payment order, file the dossier, and AGEMED evaluates. The current gob.bo procedure describes the same steps, with the documents loaded through AGEMED’s MISA platform. There are three outcomes:

• Approved. AGEMED issues the registration with a DI code for imported devices (DN for national ones).
• Observed. You get a note listing correctable technical observations and have 60 calendar days to answer them.
• Rejected. Missing core items, such as Form 027, the company documents, the parts description or labels, mean rejection. You can refile for a second evaluation within 60 calendar days, with a new payment.

Section 3.1.5 says the certificate is delivered within 30 business days of filing, valid for five years. Treat that as AGEMED’s clock for a clean file, not your end-to-end plan: consular or apostille steps, translations and any observation round come on top. Appeals of a rejection go to AGEMED’s quality-assurance committee with a technical justification (5.4).

After approval

• Registration number on pack (5.7.1). The number has to be printed, stamped in indelible ink or applied as a sticker in a visible place.
• Notifications (5.9). Notify AGEMED before marketing starts (the manual’s notifications carry a 15-business-day deadline). Also send a reference sale price before launch or a price change, and notify changes of technical responsible, closures and address changes.
• Changes (2.10 and 5.10). Non-substantial changes, such as secondary components, packaging, labels, design, power source, manufacturing process, shelf life or company name, are rectifications that keep the original number and validity.
• Renewal (3.1.7). File in the three months before expiry. The manual gives a short tolerance after expiry, but late renewals are charged as a new inscription.
• Cancellation (5.11). AGEMED can cancel a registration for undisclosed substantial changes or after an alert review, with market withdrawal at 72 hours, three months or nine months depending on the risk.

What this file is not

• It is not a clinical-trial authorization. FIH study approval runs on a separate track; see our Bolivia CRO page.
• It is not part of the bioaccess® fixed-price market-access subscription. That subscription covers only multi-importer countries plus Argentina. Bolivia is quoted as scoped, manufacturer-funded processing.

How bioaccess® runs Bolivia registrations

bioaccess® processes AGEMED registrations funded by the manufacturer. That covers Annex 2 grouping and classification, the Chapter II dossier, the legalization and translation plan, the filing, agency liaison and post-approval notifications. Local counsel reviews your representation document and distribution agreement so that ownership and control stay where you intend them. AGEMED sets its own service fees, and we confirm scope and pricing at proposal. Details: bioaccessla.com/market-access/bolivia-agemed.

Operator checklist

1. Cite the device manual and gob.bo procedure 82 (RM 0265/2018, RM 010), not RM 0909, in your SOPs.
2. Map your catalogue to the Annex 2 groups before you count filings.
3. Choose a Bolivian importer with a current Certificado de Empresa and a technical responsible who can sign Form 027.
4. Write the Section 3.2.1 ownership language into the distribution agreement.
5. Get quality-system certificates under two years old for every plant, and plan legalization of the certificate of free sale early.
6. Prepare Spanish labels, manuals and the Bolivian seller sticker before filing.
7. Calendar renewal for the three months before the five-year expiry.