Panama Medical Device Regulatory Timeline: 2017 to 2026

Updated: 2026-11-11 · GRZAN Regulatory Team · Verification date 2026-10-20

1. Key takeaways

The regulatory history of medical devices in Panama falls into two periods. 2017 to 2023 was construction: Ley No. 90 of 26 December 2017 (Gaceta 28433-B) created the authority and the institutional skeleton, Ley No. 92 of 12 September 2019 pressed pause on the issuance of registrations, and DE 490 of 4 October 2019 (Gaceta 28875-A) with amendments DE 416 and DE 1689 built the operative layer. 2024 to 2026 is tightening and transition: Resolución No. 003 of 15 February 2024 (published 4 March 2024) fixed the route for condoms and introduced a fee of B/.300.00, Comunicado No. 009 of 25 September 2023 standardised the distributor representation letter, and WTO notification G/TBT/N/PAN/135 of 8 December 2025 began a wholesale replacement. The proposed adoption date remains pending, comments closed on 6 February 2026, and as of 29 October 2026 no approved text was located in the Official Gazette.

2. Legal basis

The chronology below records instruments rather than commentary. It shows both which text governs a filing submitted today and how many formal requirements entered through administrative resolutions rather than the decree itself. The last three rows are procedural events.

2017-12-26 (published 2017-12-27)	Ley No. 90 on medical devices and related products	Gaceta Oficial Digital No. 28433-B	52 articles; Art. 2 MINSA as authority, Art. 3 creates DNDM, Art. 5 product list, Art. 6 42 definitions, Art. 7 functions, Art. 8 six-month pre-registration of stock, Art. 11 joint classification, Art. 15 registration and no prior testing, Art. 18 reliance, Art. 21 five import cases, Art. 23 transition of 18, 24, 30 and 42 months by class, Art. 27 twelve import items, Art. 28 duty exemption, Arts. 29 to 33 vigilance, Arts. 35 to 44 offences, Art. 52 effect the following day
2019-09-12	Ley No. 92	Amends Ley 90	Creates a moratorium; Art. 18 authorises the health authority to set the start date for issuing sanitary registrations
2019-10-04	Decreto Ejecutivo No. 490	Gaceta Oficial Digital No. 28875-A	74 articles; Art. 13 five-year licence with renewal 60 working days before expiry, Art. 14 five licence types, Art. 20 45 working days plus 45 for correction, Art. 21 CCT of five years, free and mandatory for procurement, Art. 30 A to D classes, Art. 36 thirteen general requirements, Art. 38 seventeen instruction items, Art. 40 twelve label items, Art. 56 72-hour report, Art. 62 implant traceability, Art. 64 fees, Art. 74 effect on publication
2019-10-30	Resolución No. 852	MINSA	Operating licence procedure manual
2020-05-13	Decreto Ejecutivo No. 416	Gaceta Oficial Digital No. 29023-A	Amends Art. 17; rewrites Art. 36, item 10 to require a currently valid ISO 13485; adds Art. 36-A with ten items for domestic manufacture; Art. 6 in force the following day
2020-12-29	Decreto Ejecutivo No. 1689	Gaceta Oficial Digital No. 29187-A	COVID-related devices may file foreign documents with an undertaking and certify within 180 working days after CCT issue; Art. 4 limits the rule to the state of emergency
2020-12-29	Resolución No. 1404	MINSA	Extends DNFD condom registration to 2021-09-30
2021-10-11	Resolución No. 091	MINSA	Repeals Resolución 019/2020 on temporary extension of licence validity
2022-03-02 and 03	Resolución No. 120 and No. 122	MINSA	Classifies products listed in the annexes to Resolución 766 and 767 as medicines
2023-09-06	Resolución No. 694	MINSA	Approves the classification of dressings containing active ingredients
2023-09-25	Comunicado No. 009	DNDM	Standardises the Panama distributor representation letter with six items a to f and requires apostille; signed by Director Dr. Rusbel Batista Ortega
2024-02-15 (published 2024-03-04)	Resolución No. 003	MINSA	Condoms as OTC; pure OTC retail exempt from licence; issues a Certificado de Inscripción; family structure not applicable; 30 working days; designates IEA at the University of Panama as reference laboratory; fee B/.300.00; repeals Resolución 004/2023; in force on publication
2025-10-15 (non-official, pending verification)	Public consultation on the draft new administrative decree	MINSA, third-party monitoring record last verified 2026-09-16	Record indicates the consultation was extended at CCIAP’s request; subject to MINSA announcement
2025-12-08	WTO notification G/TBT/N/PAN/135	WTO TBT	New decree regulating Ley 90 and Ley 92; 13 stages including IVD; basis 2.9.2; ICS 11; adoption pending; effect six months after notification; 60-day comment period
2025-12-17	Publication of the same notification	WTO TBT	Notified text made public
2026-02-06	Comments close	WTO TBT	Sixty days from the date of notification
2026-10-29	Verification date of this volume	—	No approved text located in the Official Gazette; DE 490 and its amendments remain in force

3. Expert insights

Insight 1: the fact that registration has not opened is the key to the whole timeline. Ley 90 created sanitary registration in 2017, and Article 18 of Ley 92 handed the start date to the health authority in 2019; it has not opened since. That explains an apparent contradiction: the law designed a registration, but the market runs on the CCT. Article 21 of DE 490 defines the CCT as a five-year, free credential mandatory for public procurement, not a substitute for registration but a parallel instrument created for the transition.

Insight 2: the two 2020 decrees pull in opposite directions, and both left lasting effects. DE 416 changed ISO 13485 from optional to a currently valid requirement by rewriting item 10 of Article 36, which is a tightening. DE 1689 allowed foreign documents for COVID devices with an undertaking and certification within 180 working days, a relaxation, but Article 4 confined it to the state of emergency. The first became a permanent threshold; the second expired with the emergency. Treating DE 1689 as an available channel today is a common misreading.

Insight 3: the 2023 and 2024 activity concentrated on boundaries and formats. Resoluciones 120 and 122 of 2022 designated certain products as medicines, and Resolución 694 of 2023 approved the classification of dressings with active ingredients; both address the drug-device boundary. Comunicado 009 standardised the distributor letter and Resolución 003 created a separate route for condoms; both address document format and a specific category. None touched the institutional skeleton, but together they raised the formal threshold for a dossier.

Insight 4: the transition began in 2025 and has not landed. PAN/135 is the only confirmable major change in the last two years, and it remains at the pending adoption stage. Across the whole period, Panamanian device regulation has moved through construction, suspension, refinement and replacement, and the fourth step is unfinished. The compliance baseline today is still DE 490 and its amendments.

4. Practical recommendations

Schedule production against DE 490 in force, and prepare capability against the transition. The first determines what can be done now; the second determines how much flexibility the dossier structure needs, especially for IVD, traceability and advertising copy.
Record the two 2020 amendments separately. ISO 13485 under DE 416 is a long-term obligation; the 180 working days under DE 1689 ended with the emergency and should not enter a procedure.
Turn the 2023 and 2024 format requirements into templates. The distributor letter follows the six items of Comunicado 009 with apostille; specific categories follow the ten document types and B/.300.00 fee of Resolución 003.
Use the Official Gazette as the criterion for the transition. Once the approved PAN/135 text is published, re-check article numbers and deadlines against it and update the related volumes and the quick-reference table.
Review the source list once a year. This chronology is verified to 2026-10-29 and should be re-verified in the same month next year, so that repealed provisions are not carried forward.

5. Verification checklist

□ Construction-phase instruments recorded: Ley 90 with 52 articles, Article 18 of Ley 92, DE 490 with 74 articles and Resolución 852
□ Both amendments recorded, with DE 416 on mandatory ISO 13485 kept distinct from the DE 1689 facility limited to the emergency
□ Boundary, classification and format files recorded: Resoluciones 120, 122 and 694, and Comunicado 009 with six items a to f and apostille
□ Resolución 003 recorded with 30 working days, B/.300.00, IEA reference laboratory and repeal of Resolución 004/2023
□ PAN/135 recorded: notified 2025-12-08, published 2025-12-17, comments closed 2026-02-06, adoption pending
□ Confirmed that no approved text had been published as of 2026-10-29 and that DE 490 remains in force

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

Disclaimer

Prepared by GRZAN from publicly available regulation. It is provided for general information only and does not constitute legal advice. Legislation and official fees are subject to change by the competent authority.

About GRZAN

GRZAN (Global Regulatory Zone Access Navigator) — the global market-access navigator for medical devices and IVDs.

GRZAN is a specialist consultancy for medical device and IVD market access, providing end-to-end regulatory solutions across the product lifecycle and making international market entry simpler and faster.

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What we do. Global market access: multi-country registration programmes, technical documentation, regulatory advice. Clinical evidence: clinical evaluation reports (CER), usability studies, overseas clinical investigations. Quality systems: ISO 13485, MDSAP, FDA QMSR and BGMP implementation and audit readiness. Authorised representative and licence-holder services across Southeast Asia, Latin America, the Middle East, Africa, Europe and North America.

Why GRZAN. A real operating entity, with the certificate held by the manufacturer: our direct overseas subsidiaries act as the compliant local holder, so the regulatory relationship stays clear and you keep control rather than being tied to a distributor. Direct access to the team: no time-zone gap, no language barrier, no cultural gap. Review points anticipated: we know what FDA 510(k), EU MDR, Southeast Asian, Latin American and Middle Eastern reviewers look for, which shortens timelines and reduces deficiency letters. Pathway planning: pre-decision analysis and risk assessment before you commit.

Every engagement rests on three commitments: efficiency through pre-submission review, certainty through a clear pathway, and stability through a licence-holder that stays in place.

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