Bolivia Medical Device Import: Form 011 and the CADA Customs Clearance Certificate

1. Key takeaways

The import step in Bolivia is separate from the sanitary registration. Every consignment requires a customs clearance authorisation certificate (Certificado de Autorización de Desaduanización, CADA) issued by AGEMED, applied for on Form 011, with the service fee charged at the tariff of R.M. N° 0265 (25 May 2018). The supporting documents include the commercial invoice, the packing list or a statement of batch numbers and expiry dates, a quality control certificate for each batch, and a technical data sheet for biomedical equipment and accessory spare parts. GRZAN’s warning is that holding a sanitary registration does not mean the product can be imported: the CADA is a separate action for each consignment, and it is the document that precedes clearance.

The distinction matters because the two approvals answer different questions. The registration establishes that the product may be marketed in Bolivia; the CADA establishes that a specific quantity, produced on specific dates and shipped on a specific invoice, may enter the country. Regulators use the second to confirm that what is arriving matches what was approved, which is why the batch-level documents carry the weight they do.

For planning purposes the CADA should be treated as a recurring operational step with its own lead time and its own document set, not as a task that follows automatically from a valid registration. Manufacturers that build it into the shipping calendar avoid the most common Bolivian import failure, which is cargo arriving at the port against an incomplete file.

2. Legal basis

Form 011 supplies the application itself and the document list that goes with it; Resolución Ministerial N° 0265 supplies the fee and the procedural route; section 5.7.1 of the manual ties the import step to the registration framework; and Article 42 of Decreto Supremo N° 25235 supplies the requirement that the importing enterprise hold registrable legal representation from the manufacturer. The four operate as a sequence, and the sequence has a fixed order: registration first, representation in force throughout, and CADA before each consignment is cleared.

3. Expert insights

Insight 1: a quality control certificate per batch is the standard requirement, not the exception. The document list requires a quality control certificate, or an equivalent document, for every batch to be imported. This means that the manufacturer’s batch release process has to match the shipping rhythm: certificates cannot be produced after the goods have left, and a batch that was released for another market without a certificate in the required form creates a gap at the border rather than at the plant. Where the product is released in large campaigns, the release schedule should be aligned with the shipment plan rather than with production convenience.

Insight 2: legal representation is checked again at the clearance stage. The document list requires that, for the import of legally recognised medicines or products, the enterprise hold valid legal representation at the time of examination, and that this representation has previously been submitted to the AGEMED vigilance and control area, licensing section, in original form, certified or apostilled. This confirms the position set out in article 34 of this series: the representation filing is a common precondition running through both registration and import, and its validity has to be tested against the date of clearance, not only against the date of filing.

Insight 3: the scope of the CADA is wider than commercial import. The list makes clear that it covers authorisation to import for production, promotion, registration samples, quality control standards, market research or general commercialisation. Registration samples therefore also require a CADA, a point frequently overlooked when samples are couriered to a laboratory or to the authority, and a point that can delay a technical study by the length of a clearance cycle.

Insight 4: the CADA is a per-consignment instrument, so the cost is variable rather than fixed. Because each shipment requires its own authorisation at the fee set by R.M. N° 0265, the import cost scales with the number of consignments rather than with the value of the goods. Consolidating shipments reduces the number of CADA applications, which is a budget lever that manufacturers with fragmented order patterns routinely overlook.

4. Practical recommendations

1. Make the CADA a standard node in the shipping process, and share the document list and the lead times with the customs broker in advance of the first shipment.
2. Move batch certificate issue ahead of dispatch, so that no consignment leaves the plant without the batch documentation that the border will require.
3. Obtain a CADA before sending registration samples, and do not treat a sample consignment as exempt because the goods are not for sale.
4. Group shipments where the order pattern allows, so that the number of authorisations, and therefore the fee total, stays proportionate to the commercial value imported.

5. Verification checklist

• □ The sanitary registration has been obtained and remains valid
• □ The representation filing is in force and matches the date of clearance
• □ A quality control certificate is prepared for each batch and travels with the goods
• □ The technical data sheet for biomedical equipment and accessory spare parts is available
• □ The CADA service fee has been paid at the current R.M. N° 0265 tariff

Regulatory information verified as of October 29, 2026.

GRZAN supports medical device manufacturers, importers and authorised representatives with registration in Bolivia, including preparation of Form 011 applications for the CADA, assembly of the per-consignment document set, fee planning against the current R.M. N° 0265 tariff, and coordination with the importer and the customs broker on clearance sequencing. For assistance with an import file or a shipping schedule in Bolivia, contact the GRZAN regulatory team at info@grzanglobal.com.

GRZAN applies a writing standard of conclusions first, traceable sources and verifiable figures to its regulatory publications, and follows the practice of AGEMED and the other authorities cited in this series as it develops. For a market access and import plan that keeps registration, representation and clearance on one timeline, the team welcomes your enquiry.