Explore the medical device requirements currently available for Panama, organized by topic and linked to official sources.
Which claims, audiences, channels, approvals, and restrictions apply?
Ley 90 places 'información' and 'publicidad' for devices within its regulated activities, and classifies non-compliance with prohibitions on ambulatory (street) commercialization of regulated products as a minor fault (falta leve).
Effective from 2017-12-28
What expires, what is retained periodically, and when must renewal start?
Pending draft decree: Certificado de Registro Sanitario valid five years from issuance, renewable for five years on application up to 120 working days before expiry (Arts. 62-63); class A inscription certificate five years (Art. 59); Licencia de Operación two years, renewal 60 working days before expiry (Arts. 28-29); Certificado de Criterio Técnico five years (Art. 161). If DNDM causes renewal delay, an extension document is issued (Art. 147).
Value describes the draft text; current in-force terms differ or are unverified.
Does the event require internal documentation, notice, prior approval, transfer, or a new application?
Software and other updates that do not change the device's function do not require a change or update of the Registro Sanitario; spare parts, accessories and consumables are covered by the host equipment's registration. Compatible third-party spare parts must be covered by a certification from the equipment manufacturer before marketing.
Effective from 2017-12-28
What local class follows from which rules and decisive product facts?
PENDING DRAFT (not in force): Class A devices would follow an inscription-only route (no Certificado de Registro Sanitario); class per manufacturer's declaration of conformity — draft Arts. 58, 75, 118-121
Pending draft decree: devices classified as Class A would not require a Certificado de Registro Sanitario but must be inscribed with DNDM; the class A inscription certificate would be valid five years. IVDs grouped in four classes per GHTF/IMDRF rules, with class A IVDs likewise inscription-only.
Ley 90 Art. 23 currently subjects class A to mandatory registration after the (expired) 42-month transition.
Registration procedure and requirements are built on the device's risk classification using the most updated GHTF/IMDRF classification; DNDM is the competent body for risk classification and its classification decisions are binding, taking into account the manufacturer's recommendation.
Effective from 2017-12-28
Transition (Art. 23): registration became mandatory gradually after Ley 90 entered into force — class D 18 months, class C 24 months, class B 30 months, class A 42 months (all periods long expired).
Risk classes A through D per the most current GHTF/IMDRF classification (Ley 90 de 2017).
a
Clase A
low
b
Clase B
medium
c
Clase C
high
d
Clase D
highest
MINSA (DNDM)
Which clinical or IVD performance evidence or study is required and accepted?
Pending draft reglamento (NOT in force): for the technical evaluation of Class B, C and D in-vitro diagnostic devices the applicant must file the manufacturer's factory insert containing, among the method data, the specific performance characteristics for the qualitative or quantitative method for each sample type and analyte separately, 'including the studies supporting sensitivity, specificity and compatibility with equipment, as applicable'. The IVD performance evidence is therefore the manufacturer's own analytical validation documentation; no performance study conducted in Panama is required by the draft.
Spanish original in `excerpt` with an English translation appended. Verbatim from the draft reglamento (borrador "decreto_final_3.docx", SHA-256 d8e4abd686a6632e186035889bb3423534692624f5ad1da59cfad6560e3bebc7, re-fetched 2026-09-16, HTTP 200). This is the pending draft, NOT the in-force rule; the in-force instruments (Ley 90/2017, Decreto Ejecutivo 490/2019) are image-only scans and were not OCR-ed.
Pending draft reglamento (NOT in force): a Class C registration file must contain, on top of all Class B requirements, the manufacturer's clinical evaluation report on the safety and effectiveness of the device ('Informe de evaluación clínica de seguridad y efectividad del fabricante'), plus a description of the manufacturing materials process and of the packaging process. The draft defines a clinical evaluation report as a document issued by the manufacturer describing the process, progress or results of the evaluation and analysis of clinical data on the device, in order to verify clinical safety and performance when used as intended — i.e. the clinical evidence is the manufacturer's own file, not a Panamanian study.
Spanish original in `excerpt` with an English translation appended. Verbatim from the draft reglamento (borrador "decreto_final_3.docx", SHA-256 d8e4abd686a6632e186035889bb3423534692624f5ad1da59cfad6560e3bebc7, re-fetched 2026-09-16, HTTP 200). This is the pending draft, NOT the in-force rule; the in-force instruments (Ley 90/2017, Decreto Ejecutivo 490/2019) are image-only scans and were not OCR-ed. Definition locator: Artículo 2 (definición de "Informe de evaluación clínica"), draft reglamento.
Pending draft reglamento (NOT in force): a Class D registration file must contain, on top of all Class C requirements, a risk-management evaluation report based on ISO 14971, the manufacturer's traceability protocol, and 'clinical studies on the satisfactory use of the medical device published in indexed scientific journals or open-source type databases'. Foreign clinical evidence is therefore accepted in the form of published literature rather than a Panamanian trial. DNDM may, on stated technical justification, request additional information to evaluate safety and effectiveness.
Spanish original in `excerpt` with an English translation appended. Verbatim from the draft reglamento (borrador "decreto_final_3.docx", SHA-256 d8e4abd686a6632e186035889bb3423534692624f5ad1da59cfad6560e3bebc7, re-fetched 2026-09-16, HTTP 200). This is the pending draft, NOT the in-force rule; the in-force instruments (Ley 90/2017, Decreto Ejecutivo 490/2019) are image-only scans and were not OCR-ed.
Is the product a device, IVD, accessory, software, or borderline product locally?
In-vitro diagnostic devices (reagents, calibrators, control materials, sample containers, software, instruments) are regulated devices. 'Productos afines a dispositivos médicos' (spare parts, accessories, consumables, health furniture, materials, supplies, health PPE and anything DNDM so designates) are also covered, as are remanufactured/recertified devices, combined devices, procedure kits, trays and prostheses.
Effective from 2017-12-28
Borderline products not classified by a WHO-recognized high-standard authority are classified jointly by DNDM and the Dirección Nacional de Farmacia y Drogas (Art. 11).
'Dispositivo médico' means any instrument, apparatus, implement, machine, implant, in-vitro reagent, software, material or other similar or related article intended by the manufacturer for use in humans for medical purposes (diagnosis, prevention, control, treatment or relief of disease, etc.), not achieving its principal intended action by pharmacological, immunological or metabolic means.
Effective from 2017-12-28
Basis for local qualification of software and borderline products.
Which evidence, local deltas, formats, and signatures are required?
Pending draft reglamento (NOT in force): every document filed for the issuance of a device Certificado de Registro Sanitario must be current at the moment of filing with a minimum of thirty working days of remaining validity. This is a filing-window rule that also applies to IVDs, whose CLV, if undated as to expiry, is treated as valid for two years (draft Art. 123).
Spanish original in `excerpt` with an English translation appended. Verbatim from the draft reglamento (borrador "decreto_final_3.docx", SHA-256 d8e4abd686a6632e186035889bb3423534692624f5ad1da59cfad6560e3bebc7, re-fetched 2026-09-16, HTTP 200). This is the pending draft, NOT the in-force rule; the in-force instruments (Ley 90/2017, Decreto Ejecutivo 490/2019) are image-only scans and were not OCR-ed.
Pending draft reglamento (NOT in force): the application for a Certificado de Registro Sanitario for a Class B, C or D medical device must be filed with a defined set of documents — the application form signed by the legal representative or an attorney-in-fact empowered by a power of attorney registered in the Registro Público; ID/passport copies; the operating licence (licencia de operación) and public-registry certificate or notice of operation; colour copies of the legal manufacturer's technical literature (catalogues, data sheets, manuals, product data, instructions for use); the instructions for use and/or insert for each device; a notarised and certified copy of the legal manufacturer's letter of commitment authorising its distributor; a notarised sworn declaration of the applicant; a notarised and certified copy of the ISO 13485 certificate for every manufacturing site; a notarised and certified copy of the current Certificado de Libre Venta from the competent authority of the country of origin and/or provenance (with an explanatory note from that authority where no CLV is issued); a legible colour copy of the device labelling; the list of accessories and consumables; storage/transport instructions; the final-disposal method; proof of payment; and, where applicable, an analysis certification from the Instituto Especializado de Análisis. Class A devices and IVDs follow separate chapters.
Spanish original in `excerpt` with an English translation appended. Verbatim from the draft reglamento (borrador "decreto_final_3.docx", SHA-256 d8e4abd686a6632e186035889bb3423534692624f5ad1da59cfad6560e3bebc7, re-fetched 2026-09-16, HTTP 200). This is the pending draft, NOT the in-force rule; the in-force instruments (Ley 90/2017, Decreto Ejecutivo 490/2019) are image-only scans and were not OCR-ed.
Pending draft reglamento (NOT in force): the local filing deltas for a device registration are — technical literature in a language other than Spanish must be filed translated with the seal of a public translator authorised in the Republic of Panama ('traductor público autorizado en la República de Panamá'); the manufacturer's letter of commitment and the ISO 13485 certificate must be filed as notarised and certified copies ('copia notariada y cotejada'), one ISO 13485 certificate per manufacturing site; the CLV must likewise be a notarised and certified copy; the applicant's sworn declaration must be notarised; and the application form must be signed by the legal representative or an attorney-in-fact whose power of attorney is registered in the Registro Público.
Spanish original in `excerpt` with an English translation appended. Verbatim from the draft reglamento (borrador "decreto_final_3.docx", SHA-256 d8e4abd686a6632e186035889bb3423534692624f5ad1da59cfad6560e3bebc7, re-fetched 2026-09-16, HTTP 200). This is the pending draft, NOT the in-force rule; the in-force instruments (Ley 90/2017, Decreto Ejecutivo 490/2019) are image-only scans and were not OCR-ed.
Which manufacturer, representative, holder, applicant, importer, and distributor roles apply?
Ley 90 defines the Fabricante (designs, manufactures, conditions and labels the finished product) and the Importador (brings the product into Panama for commercialization, donation, demonstration or warranty). Any public institution, private establishment or natural person engaged in manufacture, conditioning, import, export, distribution, marketing or storage of devices must hold a Licencia de Operación issued by DNDM; that licence covers devices only, not pharmacological products.
Effective from 2017-12-28
No statutory 'authorized representative' role exists in Ley 90; the local operator is the licensed establishment.
Which establishment licences, importer permissions, and distribution controls apply?
DNDM verifies that premises meet infrastructure, equipment, hygiene and environment conditions for the regulated activities, recording an acta of the premises' fitness; it may inspect establishments ex officio or upon complaints, suspicions, vigilance reports, adverse events or device failures, with the power delegable to the Regiones de Salud.
Effective from 2017-12-28
Every device consignment entering or leaving Panama must carry (verified on the invoice and related documents): manufacturer name; importer/exporter name and address; invoice number; trade name; catalogue number; presentation; model and serial number for biomedical equipment; lot number and quantity; expiry date; a copy of the Panama Registro Sanitario (save statutory exceptions); and any other data required by the authority. Devices and biomedical equipment are exempt from all import tariffs.
Effective from 2017-12-28
CSS and MINSA are additionally exempt from ITBMS on device purchases.
What regulator fee applies to this class, route, event, and date?
Pending draft decree fee table (Art. 22), payable with the application: Licencia de Operación B/.300 (fábrica), B/.250 (acondicionadora), B/.350 (distribuidora), B/.150 (minorista), B/.350 (almacén); new Registro Sanitario B/.400 (class B) and B/.550 (classes C/D); class A inscription B/.150 (tiered to B/.750 for families of 51-100); renewals B/.300 (B) / B/.450 (C,D); Certificado de Libre Venta B/.500; import authorization B/.100; family registrations B/.600-B/.1,000.
Fee review every three years by resolution (draft Art. 24).
Costs of the Licencia de Operación, Certificado de Libre Venta, BPM/BPA/BPD certificates, the Registro Sanitario and similar certifications are set by the health authority together with DNDM and updated by executive decree; DNDM income is used exclusively to fund its services and staff training. DNDM function 27 includes ensuring payment of regulated tariffs.
Effective from 2017-12-28
The draft decree's Art. 24 would introduce a three-yearly fee review by resolution.
Which label and IFU elements, languages, symbols, and translation controls apply?
Pending draft reglamento (NOT in force): instructions for use and package inserts must carry a minimum content list — generic name or trade name; manufacturer name and address; intended use or indication; contraindications and expected side effects; identification of any incorporated drug and/or material of biological origin; any applicable storage or preservation requirement; and, for reusable devices, the appropriate reprocessing information (cleaning, disinfection, packaging and sterilisation method) as indicated by the legal manufacturer. The IFU or insert may be printed or electronic in two or more languages provided one of them is Spanish, and the use of international symbology is accepted.
Spanish original in `excerpt` with an English translation appended. Verbatim from the draft reglamento (borrador "decreto_final_3.docx", SHA-256 d8e4abd686a6632e186035889bb3423534692624f5ad1da59cfad6560e3bebc7, re-fetched 2026-09-16, HTTP 200). This is the pending draft, NOT the in-force rule; the in-force instruments (Ley 90/2017, Decreto Ejecutivo 490/2019) are image-only scans and were not OCR-ed.
Pending draft reglamento (NOT in force): for in-vitro diagnostic devices of Classes B, C and D the factory insert, as it will be marketed in the country, must be filed and, where it is in a language other than Spanish, must be translated by a public translator authorised in the Republic of Panama. IVD labels are accepted in English or Spanish; internationally recognised symbols and colours may be used provided their descriptive text is clarified in the IFU or insert; for self-testing (autoaplicadas) assays the printed label information is accepted in two or more languages provided one is Spanish; warnings and precautions must be evidenced. Re-labelling or over-labelling of any packaging is not accepted.
Spanish original in `excerpt` with an English translation appended. Verbatim from the draft reglamento (borrador "decreto_final_3.docx", SHA-256 d8e4abd686a6632e186035889bb3423534692624f5ad1da59cfad6560e3bebc7, re-fetched 2026-09-16, HTTP 200). This is the pending draft, NOT the in-force rule; the in-force instruments (Ley 90/2017, Decreto Ejecutivo 490/2019) are image-only scans and were not OCR-ed.
Pending draft reglamento (NOT in force): labels may use internationally recognised symbols, abbreviations and colours and must be printed, legible and resistant on both primary and secondary packaging. Labels are accepted in two or more languages provided one of them is Spanish; a label in a language other than Spanish is accepted only if the Spanish information is delivered separately by means of a complementary safety label. Re-labelling or over-labelling is NOT accepted on any packaging for use in the Republic of Panama. Electronic labelling must contain a means giving the user easy access to the label information (same program, web address or other means).
Spanish original in `excerpt` with an English translation appended. Verbatim from the draft reglamento (borrador "decreto_final_3.docx", SHA-256 d8e4abd686a6632e186035889bb3423534692624f5ad1da59cfad6560e3bebc7, re-fetched 2026-09-16, HTTP 200). This is the pending draft, NOT the in-force rule; the in-force instruments (Ley 90/2017, Decreto Ejecutivo 490/2019) are image-only scans and were not OCR-ed.
Pending draft reglamento (NOT in force): primary-packaging labels, printed or electronic, must state the device name; brand and catalogue or model number as it will be marketed in Panama; manufacturer name and address; date of manufacture; country of origin or provenance or an internationally recognised abbreviation; indications and contraindications of use where applicable; lot number; expiry date or shelf life; quantity or volume contained where applicable; adequate storage and preservation conditions where applicable; sterility information where the device is sterile; and a 'single use device' statement, similar phrase or symbol where applicable. For the Certificado de Registro Sanitario application, electronic labelling must be submitted in printed form.
Spanish original in `excerpt` with an English translation appended. Verbatim from the draft reglamento (borrador "decreto_final_3.docx", SHA-256 d8e4abd686a6632e186035889bb3423534692624f5ad1da59cfad6560e3bebc7, re-fetched 2026-09-16, HTTP 200). This is the pending draft, NOT the in-force rule; the in-force instruments (Ley 90/2017, Decreto Ejecutivo 490/2019) are image-only scans and were not OCR-ed.
Which current law, regulation, guidance, and transition provisions apply?
A draft executive decree re-regulating Ley 90 (as amended by Ley 92) was published by MINSA on 15 Oct 2025 for public consultation; at CCIAP's request the consultation was extended (MINSA news of 17 Dec 2025, further meetings January-February 2026). The draft would derogate DE 148/1999, DE 490/2019, DE 616/2020, DE 40/2022 and Resolución 003/2024, and would take effect six months after promulgation. As of 2026-08-25 it does not appear in MINSA's normativity listing, i.e. not yet in force.
Official MINSA file at /normatividad (project page published 15 Oct 2025; comments to eaguilarg@minsa.gob.pa).
Framework in force: Ley 90 de 26 Dec 2017 (Gaceta 28433-B); amended by Ley 92 de 12 Sep 2019; regulated by Decreto Ejecutivo 490 de 4 Oct 2019 (Gaceta 28875-A), as modified by Decreto Ejecutivo 616 de 13 May 2020, added to by Decreto Ejecutivo 849 de 2 Jul 2020 (Art. 35-A) and Decreto Ejecutivo 1689 de 29 Dec 2020 (amending Art. 35-A); Resolución 852 de 30 Oct 2019 (Licencia de Operación manual) and further DNDM resolutions (001/2021, 066/2021, 091/2021, 111/2021, 037/2022, 001/2023, 004/2023, 694/2023, 003/2024).
Titles verified verbatim on the MINSA DNDM listing page; Ley 90 and DE 490 full texts are scanned PDFs (Gaceta scans).
Which PMS plan, report, PMCF or PMPF, trend, and lifecycle-update duties apply?
DNDM must design and implement a device vigilance system to prevent, detect and correct irregularities affecting safety/efficacy (norms and guides, training, failure categorization, intervention, sanctions, standardization). Manufacturers, suppliers and all medical, scientific and technical personnel of the public and private sectors are obliged to notify the health authority of suspected adverse events or incidents, failures and alerts derived from or during the use of products marketed in Panama.
Effective from 2017-12-28
The draft would formalize this as the Programa Nacional de Vigilancia de Dispositivos Médicos (draft Arts. 185-198).
Which current form, portal, account, and submission package must be used?
MINSA publishes the current DNDM forms: Formulario de Declaración Jurada, Formulario Listado de Dispositivos Médicos a Comercializar, and Formulario de Solicitud de Licencia de Operación, plus the Registro Implantable spreadsheet for the implantable registry. Submissions are paper/e-mail based (formularios .doc/.xls on minsa.gob.pa); the draft decree directs progressive migration to electronic platforms with AIG.
Corrects the baseline 'forms and procedures under Law 90' placeholder with the named forms.
Which QMS, audit, inspection, and certificate scope is accepted or required?
DNDM is authorized to issue Certificados de Buenas Prácticas de Fabricación, de Almacenamiento and de Distribución and to regulate their issuance; Resolución 852 de 30 Oct 2019 approved the manual for the Licencia de Operación procedure, and Resolución 001 de 10 Jan 2023 sets good storage practice rules.
Effective from 2017-12-28
Draft Art. 39 would require factories to hold ISO 13485 (latest version) certification accredited by an accreditation body, or a BPM certificate.
Which recall, FSCA, notice, and authority-coordination duties apply?
DNDM may order retention of devices found in non-compliant establishments and their seizure (decomiso) by reasoned resolution. Fines range from B/.500 to B/.5,000 (minor faults), B/.5,001 to B/.50,000 (grave) and from B/.50,001 upward (gravísima). Re-packing, re-labelling and re-conditioning of devices is prohibited.
Effective from 2017-12-28
Draft Art. 199 would require suppliers to notify voluntary withdrawals within 15 working days of the manufacturer's notice, and draft Art. 200 the same for international alerts/safety notices.
Which registration, notification, listing, reliance, or conformity route applies?
Certificados de Criterios Técnicos valid at Ley 90's promulgation (issued under DE 468 de 7 Nov 2007) are treated as valid Registro Sanitario and Certificado de Criterio Técnico and keep their original validity; certificates issued after Ley 90 cannot be used as Registro Sanitario.
Effective from 2017-12-28
A six-month pre-registration database for products lacking Certificado de Criterio Técnico was set up under Art. 8.
The Registro Sanitario de Dispositivos Médicos, issued by DNDM, authorizes import, export, marketing and public/private use of a device once the applicant demonstrates with documented evidence that the product meets safety, efficacy and quality characteristics defined in international norms. Devices do not require prior laboratory analysis at processing stage, save exceptions set by the health authority. Certificates may be issued per family, and for kits/trays/systems.
Effective from 2017-12-28
Replaces the pre-2017 Certificado de Criterio Técnico regime (DE 468/2007).
Which foreign decisions or evidence can be reused, with what effect and conditions?
Existing records include acceptance, restrictions and evidence reuse. The applicable product scope and conditions are preserved below; a reference does not by itself confer market access.
No linked record is currently maintained. This does not establish that a pathway is unavailable.
Prior approval / evidence record
CE Mark (EU MDR)
Yes
Free-sale certificate and ISO 13485 evidence satisfy the technical-criterion documentary requirements
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
Decreto Ejecutivo 490 of 4 October 2019 (Gaceta Oficial 28875-A), which regulates Ley 90/2017, requires in Art. 36 numeral 11 a valid Certificate of Free Sale issued by the competent authority of the country of provenance (all such countries if more than one), and defines the CLV as the document from the competent authority of the country of provenance showing the device is registered and legally authorized for sale there. An NMPA certificate is therefore the required document for devices sourced from China; the decree names no reference agencies and provides no abridged review.
china
nmpa
China NMPA medical device registration certificate (Class II/III) or Class I filing record
panama
NMPA Class I filings and Class II/III certificates for all Panamanian device classes (registration under Ley 90/2017 and DE 490/2019)
Origin Country Evidence
Evidence Only
Product Marketing
Yes
Yes
Effective from 2019-10-04
Source passage: 11. Certificado de Libre Venta vigente, emitido por la autoridad competente del país de procedencia. Si existe más de un país de procedencia deberán presentar el Certificado de Libre Venta de todos los países, se exceptúan de este requisito los productos fabricados en la República de Panamá.
Prior approval / evidence record
FDA 510(k)/PMA
Yes
Recognised free-sale evidence from a high-standard authority under Ley 92 Art. 9 validation
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Regulatory reference
DNDM may issue the Registro Sanitario through expedited validation and acceptance of certifications issued by reference authorities recognized by the competent health authority, subject to regulation. The 2025 draft operationalizes this as a 'Proceso de Confianza Regulatoria en Autoridades Reguladoras de Referencia' and would allow registration based on a current registration from the country of origin or another reference authority (for products registered with a WHO/OPS-prequalified high-standard agency).
Effective from 2017-12-28
The automatic-recognition decree DE 2 de 7 Jan 2025 (WLA list) covers medicines only, not devices.
What review, validation, and applicant stop-clock rules apply?
Pending draft decree review clocks: Registro Sanitario applications attended within up to 30 working days from receipt of a complete request (Art. 66); Licencia de Operación within a maximum of 45 working days from delivery of complete documentation (Arts. 52/56); renewal decisions within 45 working days (Art. 95); IVD registrations within up to 120 working days from start of evaluation (Art. 137) and IVD renewals within 120 working days (Art. 146).
Draft also allows three subsanación rounds (Art. 67) and, for IVDs, 90 calendar days to cure documentation before the file lapses (Art. 126).
Is an emergency, compassionate, custom, humanitarian, or other exceptional path available?
Decreto Ejecutivo 48 de 12 de abril de 2022 regulates donations of medicines, medical devices, biomedical equipment, medical furniture and other health products, repealing DE 988 de 8 de septiembre de 2015.
Title verified on the official listing; decree text not opened.
Upon supplier request technically supported by the requiring health entity, DNDM may authorize import of devices without a Registro Sanitario in five cases: (1) emergencies from public calamities and natural disasters; (2) humanitarian need for a patient with a pathology uncommon in the country; (3) unavailability of the device in the local market for public-health needs; (4) research and teaching; (5) demonstrations at fairs and temporary exhibitions up to ninety days.
Effective from 2017-12-28
The pending draft decree adds: a request may be filed at most twice per device (except calamity/humanitarian cases) and an emergency authorization mechanism (draft Arts. 114-115).
Which standards, tests, and radio, electrical, metrology, or other overlays are triggered?
DNDM has issued product-specific rules: Resolución 066/2021 (Laboratorio Central de Referencia for IVDs), Resolución 037/2022 (waives diagnostic evaluation for self-applied SARS-CoV-2 antigen tests within registration), Resolución 694/2023 (classification of dressings with active ingredient), Resoluciones 004/2023 and 003/2024 (latex condom importation), Resolución 001/2021 (storage and distribution guidelines) and Resolución 001/2023 (good storage practices).
Draft Art. 207 would designate the Instituto Especializado de Análisis (IEA) of the Universidad de Panamá as reference laboratory for analyses; draft Arts. 127-135 set IVD documentary/field evaluation.
How are deficiencies answered, clocks handled, and decisions escalated or appealed?
Sanctions imposed under Ley 90 are appealable by recurso de reconsideración and recurso de apelación, both granted in devolutive effect; resolution of the appeal exhausts the governmental avenue (vía gubernativa).
Effective from 2017-12-28
Draft Art. 67 would allow three rounds of deficiency subsanación before rejection (re-filing only after six months).
Which UDI, device listing, database, and traceability duties apply?
Traceability of implantable medical devices is mandatory (DE 490, Chapter IV, Art. 62). Health institutions must complete the Registro Nacional de Dispositivos Médicos Implantables y Prótesis form in full, attach it to the patient's clinical record, and submit reports quarterly to DNDM's vigilance department (vigilanciadndm@minsa.gob.pa), covering all devices implanted since January 2019.
Ley 90 Art. 7.12 also tasks DNDM with developing this national registry.
DNDM must maintain an updated, public database on MINSA's website covering Licencias de Operación, Certificados de Libre Venta, Registros Sanitarios, Certificados de Criterios Técnicos, BPM/BPA/BPD certificates, safety alerts, voluntary market withdrawals and other pertinent information, respecting confidentiality where applicable.
Effective from 2017-12-28
What is reportable, by whom, where, in what format, and by what deadline?
The investigation process is determined by the risk level of the event, adverse incident or failure, and the investigation period may not exceed ninety working days after complete documentation is received.
Effective from 2017-12-28
Draft Arts. 196-198 would set reporter deadlines: 72 hours for serious adverse events, 30 working days for other events/incidents, and quarterly consolidated institutional reports.
panama:medical-device
panama
Risk classes A through D per the most current GHTF/IMDRF classification (Ley 90 de 2017).
a
Clase A
low
b
Clase B
medium
c
Clase C
high
d
Clase D
highest
MINSA (DNDM)
official-source-verified
Ley 90 de 26 de diciembre de 2017, Art. 16 (as amended by Ley 92/2019) and Decreto Ejecutivo 490 de 4 de octubre de 2019, Art. 30
https://minsa.gob.pa/sites/default/files/general/ley_90_de_26_de_diciembre_2017.pdf
2026-09-16
Panama
panama
PA
🇵🇦
Dirección Nacional de Dispositivos Médicos, Ministerio de Salud
Ministry of Health
americas
3
4-class (A, B, C, D) — GHTF/IMDRF rules, Decreto Ejecutivo 490 Art. 30
licencia-de-operacion
All classes — establishment licence (licencia de operación)
DNDM operating licence, required before any device may be imported, manufactured, stored or sold
45
45
working-days
official-verified
Decreto Ejecutivo N° 490 de 4 de octubre de 2019 (Gaceta Oficial 28875-A) — Art. 13 five-year licence, Art. 20 45-working-day licence decision, Art. 21 five-year certificate, Art. 24 30-working-day technical-criterion decision, Art. 30 risk classes
https://minsa.b-cdn.net/sites/default/files/general/decreto_ejecutivo._no._490_de_4_de_octubre_de_2019.pdf
2019-10-04
2026-08-30
3
6
months
No
No
No
certificado-criterio-tecnico
All classes — technical-criterion certificate (certificado de criterio técnico)
DNDM product certificate, required for purchase by public health institutions
30
30
working-days
official-verified
Decreto Ejecutivo N° 490 de 4 de octubre de 2019 (Gaceta Oficial 28875-A) — Art. 13 five-year licence, Art. 20 45-working-day licence decision, Art. 21 five-year certificate, Art. 24 30-working-day technical-criterion decision, Art. 30 risk classes
https://minsa.b-cdn.net/sites/default/files/general/decreto_ejecutivo._no._490_de_4_de_octubre_de_2019.pdf
2019-10-04
2026-08-30
2
5
months
No
No
No
CE Mark (EU MDR)
Yes
Free-sale certificate and ISO 13485 evidence satisfy the technical-criterion documentary requirements
FDA 510(k)/PMA
Yes
Recognised free-sale evidence from a high-standard authority under Ley 92 Art. 9 validation
Yes
Panamanian licence holder (licencia de operación)
No
Not accepted
5 years — operating licence (Decreto 490 Art. 13) and technical-criterion certificate (Art. 21)
2026-08-30
official-verified
Decreto Ejecutivo N° 490 de 4 de octubre de 2019 (Gaceta Oficial 28875-A) — Art. 13 five-year licence, Art. 20 45-working-day licence decision, Art. 21 five-year certificate, Art. 24 30-working-day technical-criterion decision, Art. 30 risk classes
https://minsa.b-cdn.net/sites/default/files/general/decreto_ejecutivo._no._490_de_4_de_octubre_de_2019.pdf
2019-10-04
2026-08-30
Ley 92 de 12 de septiembre de 2019 (Gaceta Oficial 28859-B) — Art. 8 defers device sanitary registration to technical-criterion certificates, Art. 18 transitorio leaves the start date of device sanitary registration to the health authority
https://minsa.b-cdn.net/sites/default/files/general/ley_92_de_12_de_septiembre_de_2019.pdf
2019-09-12
2026-08-30
2026-08-30
default
planning-template
Maintained planning steps and estimates, not verified regulator deadlines.
1
Pre-Submission Preparation
Gather technical documentation, quality management system (QMS) records, and clinical data required by Ministry of Health. Appoint a Panamanian licence holder (licencia de operación).
1-3 months
📋
2
Application Submission
Submit complete registration dossier to Ministry of Health including device description, risk analysis, and testing reports.
1-2 weeks
📤
3
Administrative Review
Ministry of Health reviews application for completeness. May request additional documents or clarifications.
2-4 weeks
🔍
4
Technical Evaluation
In-depth technical assessment of device safety and performance. Ministry of Health may issue questions.
45 working days
⚙️
5
Registration Approval
Upon successful review, Ministry of Health issues Panama market authorization certificate.
1-2 weeks
✅
panama
Panama
PA
DNDM (MINSA)
200
200
PAB
No
200
200
PAB
No
operating-licence-manufacturer
Licencia de Operación - Fabricante
PAB
350
B/. 350
Per licence
exact-current
official-verified
https://minsa.b-cdn.net/sites/default/files/normatividad/decreto_ejecutivo_490_de_2020.pdf
Panama Decreto Ejecutivo 490 de 4 de octubre de 2019, art. 64 (Tasas), Gaceta Oficial Digital 28875-A
2019-10-04
2026-08-25
operating-licence-conditioner
Licencia de Operación - Acondicionador
PAB
225
B/. 225
Per licence
exact-current
official-verified
https://minsa.b-cdn.net/sites/default/files/normatividad/decreto_ejecutivo_490_de_2020.pdf
Panama Decreto Ejecutivo 490 de 4 de octubre de 2019, art. 64 (Tasas), Gaceta Oficial Digital 28875-A
2019-10-04
2026-08-25
operating-licence-distributor
Licencia de Operación - Distribuidor
PAB
200
B/. 200
Per licence
exact-current
official-verified
https://minsa.b-cdn.net/sites/default/files/normatividad/decreto_ejecutivo_490_de_2020.pdf
Panama Decreto Ejecutivo 490 de 4 de octubre de 2019, art. 64 (Tasas), Gaceta Oficial Digital 28875-A
2019-10-04
2026-08-25
operating-licence-retailer
Licencia de Operación - Minorista
PAB
150
B/. 150
Per licence
exact-current
official-verified
https://minsa.b-cdn.net/sites/default/files/normatividad/decreto_ejecutivo_490_de_2020.pdf
Panama Decreto Ejecutivo 490 de 4 de octubre de 2019, art. 64 (Tasas), Gaceta Oficial Digital 28875-A
2019-10-04
2026-08-25
operating-licence-warehouse
Licencia de Operación - Almacén
PAB
150
B/. 150
Per licence
exact-current
official-verified
https://minsa.b-cdn.net/sites/default/files/normatividad/decreto_ejecutivo_490_de_2020.pdf
Panama Decreto Ejecutivo 490 de 4 de octubre de 2019, art. 64 (Tasas), Gaceta Oficial Digital 28875-A
2019-10-04
2026-08-25
operating-licence-update
Actualización de la Licencia de Operación
PAB
25
B/. 25
Per update
exact-current
official-verified
https://minsa.b-cdn.net/sites/default/files/normatividad/decreto_ejecutivo_490_de_2020.pdf
Panama Decreto Ejecutivo 490 de 4 de octubre de 2019, art. 64 (Tasas), Gaceta Oficial Digital 28875-A
2019-10-04
2026-08-25
2026-08-25
official-verified
Panama Decreto Ejecutivo 490 de 4 de octubre de 2019, art. 64 (Tasas), Gaceta Oficial Digital 28875-A
https://minsa.b-cdn.net/sites/default/files/normatividad/decreto_ejecutivo_490_de_2020.pdf
2019-10-04
2026-08-25
Panama Ley 90 de 26 de diciembre de 2017, art. 26: device tariffs are set by executive decree
https://minsa.b-cdn.net/sites/default/files/general/ley_90_de_26_de_diciembre_2017.pdf
2017-12-27
2026-08-25
2026-08-25
exact-current
Yes
panama
Panama
low
asep-homologacion-of-wireless-devices
ASEP homologación of telecommunications equipment
Radio Spectrum
Mandatory If Feature
Telecommunications Equipment Or Embedded Radio Module
Article 292 of Decreto Ejecutivo 73 of 9 April 1997, implementing Ley 31 of 1996, requires all telecommunications equipment offered for sale or lease, or used or operated in Panama, to comply with the homologation policies set by the regulator, and Resolución AN 8105-Telco of 26 November 2014 adopts the procedure; homologation is done once per brand and model. Two carve-outs from ASEP's own reasoning decide most cases, and they point in opposite directions. Terminals for accessing the personal communications (service 106) and cellular mobile telephony (service 107) networks are exempt regardless of sales channel — so a cellular-connected device may fall outside. But wireless access modules or cards inside a host product are expressly caught even where the host is not, so a Wi-Fi or Bluetooth medical device points at homologation of its radio module. Annex A, the procedure itself, is not contained in the published resolution and was not read.
reviewed
iea-reference-laboratory-quality-control-analysis
IEA reference-laboratory quality-control analysis
Product Specific Conformity
Included In Medical Registration
Ivd Or Device Sample
Resolución N° 066 of 24 September 2021, listed on the MINSA Dirección Nacional de Dispositivos Médicos page, extends the designation of the Laboratorio Central de Referencia en Salud Pública as the entity regulating in vitro diagnostic medical devices, transfusion medicine and blood services. The Instituto Especializado de Análisis (IEA) appears only in the draft device regulation (draft Art. 82, 'Certificación de análisis del Instituto Especializado de Análisis (IEA) (cuando aplique)'); no in-force instrument or fee for IEA analysis was evidenced.
candidate
ASEP (Autoridad Nacional de los Servicios Públicos, Panamá)
Resolución AN 8105-Telco — homologación scope, mobile-terminal exemption and embedded module inclusion
https://www.asep.gob.pa/wp-content/uploads/telecomunicaciones/resoluciones/anno_8105_telco.pdf
MINSA (Panama)
Dirección Nacional de Dispositivos Médicos — Resolución 066/2021 IEA reference laboratory
https://www.minsa.gob.pa/contenido/direccion-nacional-de-dispositivos-medicos
