When More Clinical Evidence Is Needed: DE 490 Article 42

1. Key takeaways

Article 42 of Decreto Ejecutivo N° 490 provides that, whatever the risk class of the device, one of six situations will require a more rigorous inspection and/or the submission of more clinical evidence. The six are: the device uses innovative technology; the manufacturer states a new purpose or a purpose different from the use described in earlier assessments; the device is new to the manufacturer; that type of device tends to be associated with an excessive number of adverse events, including use error; the device contains innovative materials or potentially hazardous materials; and the device raises a public health concern.

The trigger is deliberately independent of classification. A class A device that uses an innovative technology or an innovative material is caught by the same article as a high-risk implant, so the reflex that a lower class means a lighter file does not hold in these six cases. The provision is best read as a screening tool applied before the file is assembled, not as a query that arrives during review.

• Six triggers under Article 42, applying regardless of risk class.
• The triggers are alternative, not cumulative: any one of them is sufficient.
• The consequence is a stricter inspection and/or more clinical evidence, not automatic refusal.
• Novelty is measured against the manufacturer experience, not against the market.
• A change of intended purpose interacts with the major change rules under Article 43.

2. Legal basis

The provision is Article 42 of Decreto Ejecutivo N° 490 of 4 October 2019. It operates alongside the clinical requirements of Article 37, the definitions of clinical investigation and of the clinical summary in Article 2, and the manufacturer support letter mechanism in Article 25.

The six situations are drafted as alternatives. Nothing in the text requires more than one to be present, and nothing limits the article to devices above a particular class, which is the point of the opening words.

3. Expert insights

Insight one: Article 42 is a cross-class trigger, so a low-risk product can also be subjected to enhanced review. The key phrase is the opening reference to regardless of risk. A class A device that uses innovative technology or innovative materials is caught in the same way. The article breaks the habitual assumption that low risk means low requirements, and it is the risk point most easily overlooked when a class A file is being prepared.

Insight two: item 3, the device being new to the manufacturer, is a highly subjective standard. The text reads: when the device is new for the manufacturer. The test is not first placement on the market but the experience of that particular manufacturer. A company entering a product category for the first time may trigger enhanced review even where the category itself is mature in the market. A manufacturer new to a category should therefore assume enhanced review and prepare the additional evidence accordingly.

Insight three: item 2 connects directly with change management. The wording covers a purpose declared by the manufacturer that is new or different from the use described in earlier assessments, and an extension of indications is precisely that situation. Read with Article 43, which treats the use, whether new or extended, and the addition or removal of any contraindication, as a substantial change to the device, the conclusion is that extending a use is both a substantial change and a trigger for enhanced review. The two apply cumulatively rather than in the alternative.

Insight four: Article 25 provides a formal remedy where the evidence is thin. Where the manufacturer technical literature submitted by the supplier does not demonstrate, at certain points, that the product complies with the CTNI Ficha Técnica, the DNDM may accept a duly authenticated manufacturer support letter (carta de sustentación) in the DNDM format. The text adds that no limits will be set on the number of points the manufacturer may supply. Read with Article 42, the mechanism is significant: where more evidence is needed, the manufacturer support letter is a supplementary route with no numerical cap.

4. Practical recommendations

• Screen the product against the six items of Article 42 at project set-up, and where any one is met, assume an enhanced review cycle and budget the additional evidence.
• Where the company is entering a category for the first time, assume enhanced review under item 3 and prepare clinical and post-market data on comparable products in advance.
• Before extending a use, assess both Article 42, item 2 and Article 43, and plan for the two obligations rather than for one.
• Where the technical literature cannot cover an item in the Ficha Técnica, use the manufacturer support letter under Article 25, remembering that the number of points is not capped.
• Organise the clinical evidence package according to the structure of definition 86, covering objective, design, sample size, blinding, randomisation, arms, duration, population and variables.
• Record the outcome of the six-item screen in the file, so that the assessment is visible if the authority raises the question later.

5. Verification checklist

• □ Six-item screen under Article 42 completed and the conclusion recorded
• □ Where any situation is met, additional clinical evidence prepared
• □ Company new to the category treated as enhanced review under item 3
• □ Extended use assessed against both Article 42, item 2 and Article 43
• □ Gaps in the technical literature covered by a manufacturer support letter under Article 25
• □ Clinical material organised according to the nine elements of definition 86

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.