CCT General Requirements: The 13 Items of DE 490 Article 36

1. Key takeaways

The technical standards certificate (Certificado de Conformidad Técnica, CCT) application is built on thirteen general requirements laid down in Article 36 of Decreto Ejecutivo N° 490, as amended by Decreto Ejecutivo N.º 416 of 13 May 2020. The thirteen items apply to all four risk classes, A, B, C and D, and after the amendment the heading of the article states expressly that they cover all imported medical devices. There is no shortened track for lower-risk products: the risk class only adds special requirements on top of the same baseline.

Three of the thirteen items generate most of the avoidable rejections. Item 10 requires a currently valid ISO 13485 certificate, wording that Decreto Ejecutivo N.º 416 introduced in place of the earlier reference to a good manufacturing practice certificate or another quality certification issued by an internationally recognised body. Item 11 requires a currently valid certificate of free sale from the competent authority of the country of origin, and where more than one country of origin exists, a certificate for each of them; products manufactured in Panama are exempt. Item 8 requires instructions for use or a package insert in Spanish and does not apply to biomedical equipment.

• The list is exhaustive and identical for classes A, B, C and D.
• The amended heading confines Article 36 to imported devices.
• Item 10 is now specifically an ISO 13485 certificate, not a generic quality certificate.
• Item 11 multiplies with the number of countries of origin.
• Items 8, 12 and 13 are expressly disapplied for biomedical equipment.

2. Legal basis

Decreto Ejecutivo N° 490 was published on 4 October 2019 in Gaceta Oficial 28875-A. Decreto Ejecutivo N.º 416, published on 13 May 2020 in Gaceta Oficial 29023-A, amends Article 36 through its Article 2 and inserts a new Article 36-A.

The exemptions in Article 36-A are narrow, limited to class A and B devices made by Panamanian public institutions, and they do not carry over to private manufacturers or to class C and D products.

3. Expert insights

Insight one: the amended heading narrows the scope to imported devices, and that is a structural adjustment. The original heading of Article 36 referred only to all classes, A, B, C and D. Decreto Ejecutivo N.º 416 added the words para todos los dispositivos médicos importados and created Article 36-A to deal with the domestic situation. The amendment splits the file into two documentary chains. A dossier prepared before deciding where the product is manufactured is prepared against the wrong list.

Insight two: the marking duty in item 7 expresses how Panama reviews files. The text asks the supplier to resaltar o marcar en la literatura técnica, to highlight or mark in the technical literature, the specification items that allow the evaluator to check the description in the Ficha Técnica. This is a condition of review efficiency rather than a formality: the evaluator works item by item against the CTNI specification sheet. Where nothing is marked, the review cannot advance and the file enters the correction procedure, consuming one of the sixty working day correction windows.

Insight three: item 6 demands the version current on the CTNI website, which makes it a moving requirement. Technical data sheets are updated, and a copy downloaded months earlier may already be superseded. The provision asks for a sheet that is vigente and descargadas del sitio web. Downloading it again shortly before filing is the cheapest compliance action in the list, protecting the file against a discrepancy unrelated to the product.

Insight four: three items exclude biomedical equipment, which is institutional design rather than a loophole. Biomedical equipment needs no Spanish instructions under item 8, no colour photographs under item 12 and no colour label copy under item 13, because technical information for equipment is submitted through the operation, function and maintenance manuals required separately by Article 41. Preparing equipment against the consumables list means filing inapplicable material; preparing consumables against the equipment list means omitting the labels and instructions the evaluator looks for.

4. Practical recommendations

• Build a thirteen-line verification table, marking each line as applicable, not applicable for biomedical equipment, held, or outstanding.
• Fix the manufacturing origin first, so the file is assembled against Article 36 or Article 36-A and not against a mixture of both.
• Highlight the specification items in the technical literature that correspond to the Ficha Técnica, and add a cross-reference index page.
• Re-download the Ficha Técnica from the CTNI website shortly before submission and confirm that the version is the one in force.
• Check that the ISO 13485 certificate and every certificate of free sale stay valid across the whole review period, renewing in advance rather than after a query.
• For products with several countries of origin, obtain a certificate of free sale for each of them; one certificate for the principal site will not satisfy item 11.

5. Verification checklist

• □ Confirmed whether Article 36 for imported devices or Article 36-A for domestic manufacture applies
• □ All thirteen items checked, with the three biomedical equipment exclusions marked
• □ Specification items corresponding to the Ficha Técnica marked in the technical literature
• □ Ficha Técnica is the version downloaded closest to the filing date
• □ ISO 13485 certificate currently valid under item 10 as amended by DE 416
• □ Certificate of free sale obtained for each country of origin
• □ Application form signed by a legal representative or by an agent with notarised or publicly registered authority

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

Regulatory information verified as of 29 October 2026.