The no-prior-testing principle: Article 15 of Ley 90 and its exceptions

1. Key takeaways

In principle, Panamanian device registration does not require prior testing or analysis at the registration stage. The legal basis is Article 15, second paragraph, of Ley N° 90: “Los dispositivos médicos no requieren de análisis previo en la fase de trámite del Registro Sanitario, salvo las excepciones que establezca la autoridad de salud.” This is what separates Panama from markets that require local laboratory testing. Exceptions do exist, however: Resolución N° 003 de 2024 requires condoms to be supported by a test certificate from the Specialised Analytical Institute (IEA) of the University of Panama, covering dimensions, appearance, hole detection and lubricant quantity, among other items.

• The no-prior-testing rule is a statutory principle, and the power to create exceptions sits with the health authority.
• An exception is created by a dedicated resolution that names a specific laboratory and a specific list of tests, so it can be searched for and checked.
• A request for a sample during review is a verification step, not a testing requirement, and the two should not be merged in planning.
• Article 42 gives the authority a separate route to deeper review in six defined situations, independently of testing.
• Testing capacity in Panama is organised through a university institute rather than a ministry laboratory, which affects scheduling.
• Where testing applies, its schedule has to be planned separately from the document review.

2. Legal basis

The rule and its exception sit in different instruments: the principle in the statute, the exception in a resolution that names the laboratory and the tests. Articles 36 and 42 of DE 490 add the review tools that operate whether or not testing applies.

3. Expert insights

Insight 1. No prior testing is the principle, and exceptions are created by the health authority category by category. The second paragraph of Article 15 places the power to define exceptions entirely with the health authority. Resolución N° 003 shows how that power is exercised in practice: a dedicated resolution designates a specific laboratory (IEA) and lists the specific tests to be performed. The consequence is that an exception is not a general possibility that testing might be requested; it is a searchable, checkable list. Before setting a schedule, a company should search for a resolution of this kind covering its own category, because the answer is a matter of record rather than of judgement.

Insight 2. A sample request and a testing requirement are two different things. Article 36, item 12 of DE 490 requires colour photographs of the product, and provides that a sample may be requested where necessary (en caso necesario se podrá solicitar una muestra del producto). That is a sample call during review, a means of verifying the file, and it is not the same as the prior testing or analysis referred to in Article 15. The nature differs: a sample serves visual checking, while testing produces an analytical conclusion with its own report. Confusing the two leads to a misjudgement of timelines, usually in the direction of assuming that a sample request implies a laboratory cycle that does not in fact exist.

Insight 3. Not testing does not mean not verifying, and Article 42 provides a separate route to deeper review. That article lists six situations in which stricter examination and/or additional clinical evidence is required regardless of risk class: innovative technology; a new intended use claimed by the manufacturer; a product that is new to that manufacturer; a device type that tends to be associated with an excessive number of adverse events, including use error; the presence of innovative or potentially hazardous materials; and a matter of public health concern. This is Panama’s substantive review switch. Even with no local testing, the depth of review can be raised where one of the six applies.

Insight 4. The position of the IEA shows how Panamanian testing capacity is organised. Article Décimo Quinto of Resolución N° 003 authorises the Specialised Analytical Institute attached to the University of Panama, not a laboratory built by the Ministry of Health. Reliance on university laboratories is fairly common in Central America, and its consequence is that testing capacity is affected by the academic institution’s own scheduling, so lead times are elastic. For categories where testing applies, the testing slot should be listed as a separate line in the plan rather than folded into the general timeline.

4. Practical recommendations

• Before scheduling, search category by category for a designated testing requirement, and do not assume that Panama never tests.
• Where testing applies, list the testing slot and the sample shipment separately, and do not share a single timeline with the document review.
• Distinguish a sample call from testing and analysis, and prepare a separate response for each.
• Self-assess against the six situations in Article 42 and prepare the clinical evidence package in advance where one applies.
• Manage the validity of test reports separately from certificate validity, so that an expiring report does not disturb renewal.

5. Verification checklist

• □ Record the no-prior-testing principle in Article 15, second paragraph, of Ley 90
• □ Search whether a testing resolution exists for the category (Resolución 003 is the precedent)
• □ Confirm the designated reference laboratory and the list of tests
• □ Keep the sample call and the testing analysis separate (Article 36, item 12)
• □ Self-assess against the six situations requiring deeper review under Article 42
• □ Bring test report validity into renewal management

Related reading: [Reliance pathway: expedited validation and acceptance of reference authority certificates under Article 18 of Ley 90](/panama-medical-device-registration/reliance-pathway-reference-authorities-panama/) | [Five cases of registration-exempt import: Article 21 of Ley 90, including 90 days for trade fairs](/panama-medical-device-registration/registration-exempt-import-panama/) | [The seventeen labelling and package insert items (Article 38 of DE 490)](/panama-medical-device-registration/instructions-for-use-17-items-panama/)

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