Reliance pathway: expedited validation and acceptance of reference authority certificates under Article 18

1. Key takeaways

Panamanian law contains a reliance pathway. Article 18 of Ley N° 90 provides that DNDM may issue a device sanitary registration through expedited validation and acceptance (validación y aceptación expedita) of certificates issued by reference authorities recognised by the competent authority of the country of origin, with the detailed arrangements to be laid down in regulation. It is the only provision in Panamanian law that expressly allows reliance on a foreign regulatory conclusion. One qualification matters: the article points to the sanitary registration, and the sanitary registration is currently under a moratorium under Article 18 of Ley 92, so full application of the pathway depends on the registration channel opening and on the implementing regulation being issued.

• The pathway exists in the statute but has not been operationalised, because the credential it feeds into cannot yet be issued.
• Recognition of a reference authority is decided by the competent authority of the country of origin, not by a Panamanian list.
• The statutory object of reliance is a certificate, not an approval decision.
• In the current CCT system the closest supporting evidence is the ISO 13485 certificate and the certificate of free sale required by Article 36.
• Reliance sits alongside the no-prior-testing rule, which together produce a low-friction access model.
• The same design transfers the burden of accuracy to the applicant, because the declared information is bound to a sworn declaration.

2. Legal basis

Article 18 is short and its limits are in the closing words. The surrounding provisions show what the reliance logic rests on in practice, and what checks remain available to the reviewer.

3. Expert insights

Insight 1. Recognition of a reference authority sits with the authority of the country of origin, which is an unusual design. The wording of Article 18 is “autoridades de referencia reconocidas por la autoridad sanitaria competente del país de procedencia” — reference authorities recognised by the competent authority of the country of origin, not listed by Panama itself. That differs from the more common model in which the importing regulator publishes its own list of recognised authorities. The implication for an applicant is that Panama accepts the exporting country’s endorsement of its own regulatory system, and the applicant must be able to show that the authority of the country of origin recognises the body that issued the certificate in question.

Insight 2. What is relied on is a certificate, not an approval. The provision refers to “certificaciones emitidas por autoridades de referencia” — certificates issued by reference authorities. Under the current CCT system, the evidence that corresponds most closely is the ISO 13485 certificate and the certificate of free sale required by Article 36, items 10 and 11 of DE 490, which are exactly the type of document issued by a recognised body or by the competent authority of the country of origin. So even before the reliance pathway is fully activated, its institutional logic is already visible in the current documentation list.

Insight 3. Reliance combined with the absence of prior testing produces Panama’s low-friction access profile. Article 15 removes prior testing at the registration stage, and Article 18 permits reliance on foreign certificates. Taken together, they mean that in principle Panama does not repeat technical verification. The combination is favourable to companies that already hold international certification, but it carries a mirror-image requirement: responsibility for the accuracy of the material rests entirely with the company. Article 33 of DE 490 binds all declared information to a sworn declaration, and Article 32 requires the evaluator to visit the manufacturer’s website and check the consistency of what has been submitted. Reliance reduces duplication of testing, not the duty of accuracy.

Insight 4. Reliance is not exemption from review, and Article 32 supplies the verification mechanism. That article requires the evaluator to visit the manufacturer’s lawful website, or the original manufacturer’s website declared by the supplier, and to check the consistency of the information and documents submitted. It is a low-cost verification tool and an effective one: where website information and technical literature do not match, a query follows immediately. Under a reliance model the company website becomes part of the review file, which is a practical point that applicants frequently overlook when they treat the website as marketing material rather than as a regulated statement.

4. Practical recommendations

• When preparing reliance material, first obtain proof that the authority of the country of origin recognises the issuing body, or a publicly verifiable basis for that recognition.
• Ensure that product information on the manufacturer’s website, the technical literature and the application are consistent in all three places (Article 32).
• Keep the ISO 13485 certificate and the certificate of free sale currently valid; an expired certificate is of no use under a reliance pathway.
• Do not read reliance as exemption from review, and prepare against the full documentation list.
• Track the implementing regulation: Article 18 states expressly that the mechanism will be regulated, and the conditions of use will become specific once that regulation appears.

5. Verification checklist

• □ Record the text of Article 18 of Ley 90 and its qualification that the mechanism is to be regulated
• □ Confirm the basis on which the authority of the country of origin recognises the issuing body
• □ Check that the manufacturer’s website matches the technical literature (Article 32)
• □ Confirm that the ISO 13485 certificate and the certificate of free sale are within validity
• □ Confirm the status of the sanitary registration channel, since the reliance pathway feeds into it
• □ Set a watch for the publication of the implementing regulation

Related reading: [Family applications and the three situations where the family concept does not apply](/panama-medical-device-registration/family-of-devices-panama-exclusions/) | [The no-prior-testing principle: Article 15 of Ley 90 and its exceptions](/panama-medical-device-registration/no-prior-analysis-rule-panama/) | [ISO 13485 from optional to mandatory: what Decreto 416 changed](/panama-medical-device-registration/iso-13485-mandatory-panama-decreto-416/)

Regulatory information verified as of October 29, 2026.

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