Official Fees: Article 64 of DE 490 and the B/.300 under Resolución 003

1. Key takeaways

Official fees (tasas) in the Panamanian device sector are consolidated in Article 64 of Decreto Ejecutivo N° 490, and only one credential can be priced item by item from the official text: the operating licence. The schedule sets manufacturer B/.350.00, conditioner B/.225.00, distributor B/.200.00, retailer B/.150.00, warehouse B/.150.00 and licence update B/.25.00. The technical standards certificate (CCT) is expressly free of charge under the third paragraph of Article 21. Per-category registration carries separate pricing: Article Décimo Sexto of Resolución N° 003 de 2024 sets the condom registration fee at B/.300.00, payable to the finance department of the Ministry of Health.

• Six licence prices — five establishment categories plus a single update fee, all fixed in one article of the decree.
• No sanitary registration line — the Article 64 schedule contains no fee for device sanitary registration, which is consistent with the moratorium position.
• CCT at no cost — the product-side certificate carries no fee, but it does not follow that product access is free of cost overall.
• Separate pricing for specific procedures — the condom registration fee of B/.300.00 is set by resolution rather than by the decree.
• Two payees — licence fees are paid at DNDM with the application, while the per-category registration fee is paid to the Ministry of Health finance department.
• Fees can be revised — Article 26 of Ley N° 90 provides for updating by executive decree, so the published figures are a starting point rather than a permanent schedule.

2. Legal basis

Article 64 of DE 490 of 4 October 2019 contains the licence schedule and the payment rule. The third paragraph of Article 21 states that the CCT carries no cost. Resolución N° 003 of 15 February 2024 prices a specific registration procedure. Article 26 of Ley N° 90 of 26 December 2017 supplies the mechanism by which the whole schedule may be updated.

3. Expert insights

Insight one: the fee schedule contains no item for device sanitary registration, which matches the moratorium. The table in Article 64 lists six prices, all connected with the operating licence. Read as evidence, the absence confirms that device sanitary registration has not become a routine chargeable procedure within the DE 490 system. Figures circulating in industry material, such as a registration fee somewhere between fifty and five thousand dollars, cannot be matched to Article 64 or to Resolución N° 003 and should not be relied on in a quotation. Where a client asks for a budget line labelled registration fee, the honest answer is that no such line exists in the published schedule.

Insight two: Article 26 places the power to revise fees in an executive decree, which means the amounts will change. The second sentence of Article 26 of Ley 90 reads: Las tarifas serán establecidas por la autoridad de salud y la Dirección Nacional de Dispositivos Médicos y actualizadas mediante decreto ejecutivo. The prices in Article 64 are at their 2019 level, and whether they have since been adjusted by a later decree has to be checked against the most recent instruments (practical estimate). Any quotation that presents the B/. figures as current without a search of subsequent decrees is quoting an assumption rather than a verified position.

Insight three: the CCT is free, but per-category procedures introduced since 2019 are charged. The free-of-charge principle in the third paragraph of Article 21 does not conflict with the B/.300.00 in Resolución N° 003, because the first concerns the CCT while the second concerns a registration (inscripción). The two instruments address different procedures, and the pattern is informative: as Panama rebuilds product access, the newly created procedures carry fees, while the older certificate remains free. For budgeting purposes this means the product side is not necessarily zero cost simply because the CCT is.

Insight four: the manner of payment is written into the provisions, which makes it a formal requirement. Article 64 requires that fees be paid at the Dirección Nacional de Dispositivos Médicos with the presentation of the respective application (deberán pagarse en la Dirección Nacional de Dispositivos Médicos, con la presentación de la solicitud respectiva), while Resolución N° 003 directs payment to the finance department of the Ministry of Health. The two procedures therefore have different payees and produce different proof of payment, and that proof is itself a documentary requirement: item 7 of Article 17 asks for the comprobante de pago. A receipt from the wrong office is a defective filing, not a minor irregularity.

4. Practical recommendations

• Show official fees in quotations item by item against Article 64, separately from third-party costs such as translation, notarisation and consultancy.
• State that official fees are those published at the time of filing, given the updating mechanism in Article 26.
• Exclude the CCT from the fee calculation but include ISO 13485, certification, translation and representative costs in the overall budget.
• Confirm the fee and the payee separately for each per-category procedure, noting that Resolución 003 directs payment to the Ministry of Health finance department.
• Obtain the proof of payment in the format the receiving office requires and file it as part of the application.
• Check for any later executive decree adjusting the schedule before presenting figures to a client.

5. Verification checklist

• □ Licence fees checked against Article 64 (B/.150 to B/.350)
• □ Licence update fee of B/.25.00 recorded
• □ CCT confirmed as free of charge (Article 21, third paragraph)
• □ Per-category procedure fee and payee confirmed (Resolución 003: B/.300.00)
• □ Any executive decree updating fees searched (Article 26)
• □ Proof of payment obtained in the form required by the receiving office

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support for the Panamanian market. Our team manages Ministry of Health (MINSA) sanitary registration applications, prepares Spanish-language dossiers, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com