DNDM and Unidades Tecnicas: Authorisation and Duties of Technical Units

1. Key takeaways

Panama’s technical units (Unidades Técnicas) are units inside public or private health institutions that the DNDM has authorised to take part in device management, vigilance and control. Their functions include issuing the technical criteria certificate (CCT) and handling renewals and corrections of the technical verification certificate (CVT). The consequence is that in Panama the CCT is not issued by the DNDM alone: a CCT issued by the DNDM or by an authorised technical unit is valid, but the format must follow the form designed by the DNDM (Article 10, second paragraph of DE 490). Confirming which body will receive the file is the first step in any schedule.

• The CCT can come from the DNDM or from an authorised technical unit; both are valid.
• Authorisation must be granted by resolution, so the status of a technical unit can be verified from the record.
• The form is mandatory and uniform; only the issuing institution’s name changes.
• A reconsideration request does not stay inside the technical unit. It moves the file up to the DNDM.

2. Legal basis

The technical unit is defined in Ley 90, given its operational footing in Articles 8 to 10 of DE 490, and confirmed as a possible issuer of the CCT in Article 21. The provisions are short, but each one carries a checkable fact: who is authorised, by what instrument, on which form, and with what appeal route.

3. Expert insights

Insight one: the technical unit system is Panama’s answer to limited review capacity. Article 8 of DE 490 names two existing units by way of example: the health technology department of the Social Security Fund (Caja de Seguro Social) and the central public health reference laboratory of the Gorgas Memorial Institute. Bringing technical capacity from inside the public health system into the regulatory chain is unusual in Central America. For companies, it means the technical review of a CCT may be carried out by an institution with clinical experience of using the products, so the questions asked tend to follow actual conditions of use rather than document form alone.

Insight two: authorisation must be given by resolution, which makes it verifiable. The closing sentence of Article 8 provides that the function must be authorised by resolution. The authorisation status of a technical unit can therefore be checked against the MINSA record. When a company works with an intermediary that offers to obtain a CCT on its behalf, the resolution number should be verified rather than the claim accepted. This is a short check that separates an authorised channel from an arrangement that has no legal basis, and it should be performed before any payment is made.

Insight three: the form is uniform, while the issuing institution is not. The second paragraph of Article 10 makes the DNDM form mandatory for technical units, with only the heading differing. The rule protects the formal consistency of the CCT and means that a company does not have to redesign its submission because a different body is receiving it. The real difference between issuers lies in the review, not in the form. Teams that prepare one version of the file for the DNDM and another for a technical unit are solving a problem that does not exist while missing the one that does.

Insight four: one function of the technical unit is easily overlooked, namely the upward move on reconsideration. Article 9, item 2, subparagraph b provides that when a supplier files a request for reconsideration (reconsideración) of a technical criteria assessment, the technical unit must send the file to the DNDM for re-evaluation. A reconsideration is therefore not absorbed inside the unit that issued the assessment; it moves up a level. For a company that has received an unfavourable conclusion, the route is defined, and the body that hears it sits above the body that decided.

4. Practical recommendations

• Before submission, confirm whether the CCT will be received by the DNDM or by an authorised technical unit, and verify the authorising resolution for the unit.
• Use the current DNDM form version for all material. Do not create a substitute form because the receiving body is different.
• Route review queries and corrections through the channel of the receiving body only, so that the file does not acquire conflicting statuses from parallel correspondence.
• On an unfavourable conclusion, use the reconsideration route in Article 9, item 2, subparagraph b and move the file to the DNDM for re-evaluation.
• Archive every written exchange with the technical unit, since that record becomes the evidentiary base for any later reconsideration or remedy.

5. Verification checklist

• □ Confirm whether the receiving body is the DNDM or an authorised technical unit
• □ Verify the resolution number authorising the technical unit (Article 8)
• □ Use the current mandatory DNDM form version (Article 10)
• □ Record the 5 functions of the technical unit (Article 9)
• □ Confirm the reconsideration route moves the file to the DNDM for re-evaluation (Article 9, item 2, subparagraph b)
• □ Archive all written correspondence

Regulatory information verified to 29 October 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 registrations through the DIGEMID-equivalent medical device directorate, prepares Spanish-language dossiers, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com