PAN/135: Panama’s New Medical Device Decree and WTO Notification

1. Key takeaways

The only confirmable major legislative change in Panama in the last two years is G/TBT/N/PAN/135, notified to the WTO on 8 December 2025 and published on 17 December 2025: a new administrative decree regulating Law No. 90, as amended by Law No. 92 of 12 September 2019. The notified scope covers medical devices, expressly including in vitro diagnostic devices (DMDIV), biomedical equipment and related products across 13 stages on the national territory: manufacture, preparation, import, export, re-export, information, advertising, labelling, distribution, marketing, storage, use and final disposal. The procedural elements are: notified under TBT Agreement 2.9.2 as a technical regulation; ICS code 11 (health technology); proposed date of adoption pending; proposed date of entry into force six months after notification; comment deadline 6 February 2026, sixty days from notification; responsible agency DNDM. As of the verification date of this volume, 29 October 2026, no approved text has been located in the Official Gazette, so the six-month period cannot be used as a firm effective date.

2. Legal basis

The record below reproduces the notification fields rather than interpreting them, and then places the notification alongside the instruments currently in force. That separation matters: the notification is a proposal with a procedural status, while the instruments in the lower rows remain the rules that apply to a filing submitted today.

3. Expert insights

Insight 1: the coverage list adds three stages to DE 490, which is the substantive evidence that this is not a rearrangement. Of the 13 stages in field 6, re-export, advertising and final disposal are not treated as separate regulated stages in the current decree. Re-export matches Panama’s role as a regional transhipment hub, consistent with the application of Article 1 of Ley 90 to free zones and the duty exemption in Article 28; advertising addresses promotional content that has been largely unregulated; final disposal closes the loop with the Article 58 recall notification and the Article 62 implant traceability. Three additions suggest expansion rather than simplification of company obligations.

Insight 2: IVD is written into the scope for the first time. Fields 4 and 6 both name DMDIV. Under DE 490, IVD has long been handled by applying the general device rules, without dedicated provisions on classification and documentation. Naming IVD separately responds to that ambiguity. For clients whose portfolio is mainly IVD, this is the most direct effect of the current round of change.

Insight 3: notification under 2.9.2 confirms the technical regulation status, and the final text may still change. Field 3 is 2.9.2 rather than 2.10.1 or 5.6.2, which means Panama is following the technical regulation procedure and accepting comments from WTO Members for sixty days. Comments can change the final provisions, so this volume makes no inference about article-level detail. The full text link published by the WTO could not be downloaded at the time of verification, and only the notification metadata has been used.

Insight 4: the pending date of adoption is the most important line in the record. The proposed entry into force is six months after notification, but the proposed date of adoption is pending, and as of 29 October 2026 no approved text has been located in the Official Gazette, while the third-party monitoring record last verified on 16 September 2026 still marks the text as a draft. The combined conclusion is that companies should not build a compliance plan backwards from six months, and should not use the imminence of the new decree as a reason to defer an existing CCT application. DE 490 remains in force.

4. Practical recommendations

• Do not suspend CCT and licence applications under the current route. DE 490 and its amendments remain in force, and the CCT remains the mandatory credential for public procurement under Article 21. Standing still while waiting for a new decree costs determinable market time.
• Prepare three capabilities rather than guessing at provisions. The coverage list is public, so the direction is clear: an itemised product and certificate register including CCT numbers, validity and family structure; traceability and UDI capability corresponding to final disposal and implant traceability; and a review mechanism for Spanish labelling and advertising copy.
• Run a separate gap assessment for IVD. Given that IVD is named separately, prepare classification and performance documentation on the assumption that IVD will receive standalone rules, so that the dossier structure does not have to be rebuilt later.
• Use the Official Gazette as the only criterion for entry into force. Once MINSA or the Gazette publishes the approved text, re-check article numbers and deadlines against the published version and update this article and the quick-reference table.
• Track developments through official DNDM channels. The contact details are published in the notification, and major projects should confirm the current position with DNDM in writing.

5. Verification checklist

• □ Notification number G/TBT/N/PAN/135, notification date 2025-12-08 and publication date 2025-12-17 recorded
• □ Thirteen covered stages recorded, with re-export, advertising and final disposal noted as not separately regulated in DE 490
• □ Separate naming of IVD (DMDIV) recorded
• □ Notification basis 2.9.2 and ICS 11 recorded
• □ Proposed adoption date pending and proposed entry into force six months after notification recorded
• □ Comment deadline 2026-02-06 recorded
• □ Confirmed that no approved text had been located in the Official Gazette as of 2026-10-29
• □ Confirmed that DE 490 and its amendments remain in force and that current applications have not been suspended
• □ Re-check trigger established on the basis of publication in the Official Gazette

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