Ministry of Health · structured requirements

🇵🇦 Panama IVD regulatory data

Explore the IVD requirements currently available for Panama, organized by topic and linked to official sources.

8 facts8 dimensions5 official sourceslatest verification 2026-09-16

Changes after registration in Panama

Source-linked rules for common changes to a registered IVD. Read the scope and conditions with each rule; unverified details are listed separately.

Does changing a device brand name or logo require an update?

A change to the registered brand name and a change to logo artwork can follow different rules. The legal manufacturer, device design and intended purpose remain the same.

A source-verified answer for this specific scenario is not yet published.

Label, IFU & language →

How do I update a manufacturer's name without changing the legal entity?

The same legal manufacturer changes its name, potentially alongside the device brand. A transfer to another legal entity is a separate question; permission to combine filings needs its own evidence.

A source-verified answer for this specific scenario is not yet published.

Label, IFU & language →

What changes when the manufacturer's office address changes?

An office address change for the same legal entity, potentially alongside name and brand changes. This does not cover moving a factory or manufacturing site, and a combined filing cannot be assumed.

A source-verified answer for this specific scenario is not yet published.

Label, IFU & language →

Does a catalogue or reference code change affect registration or UDI?

Check which identifier actually changes. A commercial catalogue, REF or order code is not automatically a device model, registered identifier, GTIN or UDI-DI. Rules for one identifier do not establish the route for another.

A source-verified answer for this specific scenario is not yet published.

Label, IFU & language →

Can a registration transfer to a different legal entity?

A real change of legal manufacturer, registration holder or owner. This differs from renaming the same entity; a change of local representative or importer alone does not establish a registration transfer route. Where other changes occur with the transfer, the exact combination and sequence need separate evidence.

A source-verified answer for this specific scenario is not yet published.

Can several changes be filed together?

Changes to brand, manufacturer name, office address and reference codes may occur together, including with a real transfer to another legal manufacturer, registration holder or owner. Assess transfer with each single change, and transfer with brand plus reference, manufacturer name plus reference, or office address plus reference changes: seven transfer combinations in total. Evidence must establish the exact combination and the order of filings and approvals. These combinations and their sequence are not all verified by the rules below; a rule for one change does not prove that a single application, fee or review period covers the combination.

A source-verified answer for this specific scenario is not yet published.

Dossier requirements →

Classification rules

What local class follows from which rules and decisive product facts?

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Class A route (pending draft)

classification.draft-class-a-inscription

Fact-level verified

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.

Conditions

Draft under consultation — NOT in force; current treatment of class A under DE 490 unverified.

Ley 90 Art. 23 currently subjects class A to mandatory registration after the (expired) 42-month transition.

Clinical investigation & performance

Which clinical or IVD performance evidence or study is required and accepted?

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IVD performance evidence supplied from the manufacturer's insert (pending draft)

clinical.ivd-analytical-performance-evidence

Fact-level verified

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.

Conditions

Draft instrument under public consultation — NOT in force. MINSA published this file at minsa.gob.pa/sites/default/files/normatividad/decreto_final_3.docx; it would repeal Decreto Ejecutivo 490/2019 (draft Art. 225) and take effect six months after promulgation (draft Art. 227). No promulgated replacement reglamento appears in MINSA's normativity listing as of 2026-09-16.
Evidence is filed as part of the dossier; the draft provides for a field and/or documentary technical evaluation decided by DNDM (draft Art. 127), not for a local performance 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.

Device definition & scope

Is the product a device, IVD, accessory, software, or borderline product locally?

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Dossier requirements

Which evidence, local deltas, formats, and signatures are required?

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Documents must be current with 30 working days' minimum validity (pending draft)

dossier.document-validity-window

Fact-level verified

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).

Conditions

Draft instrument under public consultation — NOT in force. MINSA published this file at minsa.gob.pa/sites/default/files/normatividad/decreto_final_3.docx; it would repeal Decreto Ejecutivo 490/2019 (draft Art. 225) and take effect six months after promulgation (draft Art. 227). No promulgated replacement reglamento appears in MINSA's normativity listing as of 2026-09-16.

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.

Label, IFU & language

Which label and IFU elements, languages, symbols, and translation controls apply?

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IVD IFU translation and label language (pending draft)

label.ivd-ifu-translation-and-label-language

Fact-level verified

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.

Conditions

Draft instrument under public consultation — NOT in force. MINSA published this file at minsa.gob.pa/sites/default/files/normatividad/decreto_final_3.docx; it would repeal Decreto Ejecutivo 490/2019 (draft Art. 225) and take effect six months after promulgation (draft Art. 227). No promulgated replacement reglamento appears in MINSA's normativity listing as of 2026-09-16.
This is the only provision in the draft that accepts English alone on a label, and it is confined to IVDs; non-self-test IVD labels therefore need English or Spanish, while the IFU still needs an authorised Spanish translation.

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.

Reliance & recognition

Which foreign decisions or evidence can be reused, with what effect and conditions?

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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.

Panama approvals and evidence in other markets (0 records)

No linked record is currently maintained. This does not establish that a pathway is unavailable.

Prior approvals and evidence for Panama (3 records)

PanamaEU conformity assessment

Prior approval / evidence record

CE Mark (EU MDR)

Authority: CE Mark (EU MDR)
Accepted: Yes
Benefit: Free-sale certificate and ISO 13485 evidence satisfy the technical-criterion documentary requirements

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 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

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

Prior approval / evidence record

China NMPA approval: origin evidence only

reliance.china-nmpa-origin-evidence

Pending verification

Statement: 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.
Source Jurisdiction Id: china
Source Authority Id: nmpa
Source Approval: China NMPA medical device registration certificate (Class II/III) or Class I filing record
Target Jurisdiction Id: panama
China Classes In Scope: NMPA Class I filings and Class II/III certificates for all Panamanian device classes (registration under Ley 90/2017 and DE 490/2019)
Edge Type: Origin Country Evidence
Market Access Strength: Evidence Only
Regulatory Layer: Product Marketing
Local Application Required: Yes
Target Decision Retained: Yes

Conditions

Art. 36.11: CLV from every country of provenance; Panama-made devices exempt
Art. 35: foreign documents legalized or apostilled
Art. 36.10: GMP certificate or other quality certifications issued by recognized entities
Independent verification is incomplete. Treat this record as a research lead, not a confirmed benefit or exclusion; see the 2026-09-15 independent review.

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.

PanamaUS FDA

Prior approval / evidence record

FDA 510(k)/PMA

Authority: FDA 510(k)/PMA
Accepted: Yes
Benefit: Recognised free-sale evidence from a high-standard authority under Ley 92 Art. 9 validation

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 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

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

Review clocks

What review, validation, and applicant stop-clock rules apply?

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Review timelines (pending draft)

clocks.draft-review-deadlines

Fact-level verified

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).

Standards, testing & ancillary approvals

Which standards, tests, and radio, electrical, metrology, or other overlays are triggered?

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Product-specific technical resolutions

ancillary.product-specific-resolutions

Fact-level verified

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).

Conditions

Titles verified on the official DNDM normativity listing; individual PDFs are scans.

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.

Related structured datasets

Classification systems · 0 records

No maintained record.

Registration pathways, prior approvals and planning · 1 record

These country-level records can cover multiple product types. Check each item's scope and conditions before applying a fee, pathway or licence to an IVD.

Open Panama registration →

Country

Panama

Jurisdiction Id

panama

Country Code

PA

Flag

🇵🇦

Regulator

Dirección Nacional de Dispositivos Médicos, Ministerio de Salud

Regulator Abbrev

Ministry of Health

Region

americas

Tier

3

Risk Classification

4-class (A, B, C, D) — GHTF/IMDRF rules, Decreto Ejecutivo 490 Art. 30

Classes

Id
licencia-de-operacion
Class Name
All classes — establishment licence (licencia de operación)
Pathway
DNDM operating licence, required before any device may be imported, manufactured, stored or sold
Official Timeline
Min
45
Max
45
Unit
working-days
Verification Status
official-verified
Official Source
Title
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
Url
https://minsa.b-cdn.net/sites/default/files/general/decreto_ejecutivo._no._490_de_4_de_octubre_de_2019.pdf
Effective Date
2019-10-04
Accessed Date
2026-08-30
Realistic Timeline
Min
3
Max
6
Unit
months
Notes
Art. 20: applications for issue, update, renewal and correction are decided within 45 working days once the requirements are shown to be met
If the DNDM asks for additional information the applicant gets a further 45 working days, and silence is treated as withdrawal
Art. 13: the licence runs five years and renewal must be filed 60 working days before expiry
Clinical Trial Required
No
Local Testing Required
No
Gmp Required
No
Id
certificado-criterio-tecnico
Class Name
All classes — technical-criterion certificate (certificado de criterio técnico)
Pathway
DNDM product certificate, required for purchase by public health institutions
Official Timeline
Min
30
Max
30
Unit
working-days
Verification Status
official-verified
Official Source
Title
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
Url
https://minsa.b-cdn.net/sites/default/files/general/decreto_ejecutivo._no._490_de_4_de_octubre_de_2019.pdf
Effective Date
2019-10-04
Accessed Date
2026-08-30
Realistic Timeline
Min
2
Max
5
Unit
months
Notes
Art. 24: the DNDM answers within 30 working days of complete documentation; after a request for corrections the applicant has 60 working days and the DNDM then has a further 30 working days
Art. 21: the certificate runs five years and, for public procurement, is issued free of charge
Art. 31: Class C and D evaluations must convene two or more clinical specialists who use the device; for Class A and B that step is optional
Clinical Trial Required
No
Local Testing Required
No
Gmp Required
No

Key Requirements

Device sanitary registration is still deferred: Ley 92 of 2019 Art. 8 replaced it with technical-criterion certificates, and Art. 18 transitorio leaves the start date to the health authority, to be phased in by risk class beginning with the highest
Until that start date, private-market supply is gated by the establishment licence rather than by a product registration, so no product clock applies outside public procurement
Both clocks are per-file working-day periods; the DNDM may authorise formal extensions on the evaluator's or the applicant's request (Art. 24)
Risk class follows the current GHTF/IMDRF rules, and a device that fits two classes takes the higher one (Art. 30)

Prior Approvals

Authority
CE Mark (EU MDR)
Accepted
Yes
Benefit
Free-sale certificate and ISO 13485 evidence satisfy the technical-criterion documentary requirements
Authority
FDA 510(k)/PMA
Accepted
Yes
Benefit
Recognised free-sale evidence from a high-standard authority under Ley 92 Art. 9 validation

Local Rep Required

Yes

Local Rep Name

Panamanian licence holder (licencia de operación)

Mdsap Accepted

No

Mdsap Benefit

Not accepted

Registration Validity

5 years — operating licence (Decreto 490 Art. 13) and technical-criterion certificate (Art. 21)

Last Updated

2026-08-30

Verification Status

official-verified

Official Sources

Title
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
Url
https://minsa.b-cdn.net/sites/default/files/general/decreto_ejecutivo._no._490_de_4_de_octubre_de_2019.pdf
Effective Date
2019-10-04
Accessed Date
2026-08-30
Title
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
Url
https://minsa.b-cdn.net/sites/default/files/general/ley_92_de_12_de_septiembre_de_2019.pdf
Effective Date
2019-09-12
Accessed Date
2026-08-30

Reviewed On

2026-08-30

Process

Template Id

default

Status

planning-template

Usage Rule

Maintained planning steps and estimates, not verified regulator deadlines.

Steps

Step
1
Title
Pre-Submission Preparation
Description
Gather technical documentation, quality management system (QMS) records, and clinical data required by Ministry of Health. Appoint a Panamanian licence holder (licencia de operación).
Duration
1-3 months
Icon
📋
Step
2
Title
Application Submission
Description
Submit complete registration dossier to Ministry of Health including device description, risk analysis, and testing reports.
Duration
1-2 weeks
Icon
📤
Step
3
Title
Administrative Review
Description
Ministry of Health reviews application for completeness. May request additional documents or clarifications.
Duration
2-4 weeks
Icon
🔍
Step
4
Title
Technical Evaluation
Description
In-depth technical assessment of device safety and performance. Ministry of Health may issue questions.
Duration
45 working days
Icon
⚙️
Step
5
Title
Registration Approval
Description
Upon successful review, Ministry of Health issues Panama market authorization certificate.
Duration
1-2 weeks
Icon
✅

Government fee schedules · 1 record

These country-level records can cover multiple product types. Check each item's scope and conditions before applying a fee, pathway or licence to an IVD.

Open Panama fees →

Jurisdiction Id

panama

Country

Panama

Country Code

PA

Authority

DNDM (MINSA)

Low Risk Local

Min: 200
Max: 200
Currency: PAB
Per Product: No

High Risk Local

Min: 200
Max: 200
Currency: PAB
Per Product: No

Details

Id
operating-licence-manufacturer
Item
Licencia de Operación - Fabricante
Currency
PAB
Amount Local
350
Amount Local Formatted
B/. 350
Frequency
Per licence
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://minsa.b-cdn.net/sites/default/files/normatividad/decreto_ejecutivo_490_de_2020.pdf
Source Title
Panama Decreto Ejecutivo 490 de 4 de octubre de 2019, art. 64 (Tasas), Gaceta Oficial Digital 28875-A
Source Effective Date
2019-10-04
Verified On
2026-08-25
Id
operating-licence-conditioner
Item
Licencia de Operación - Acondicionador
Currency
PAB
Amount Local
225
Amount Local Formatted
B/. 225
Frequency
Per licence
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://minsa.b-cdn.net/sites/default/files/normatividad/decreto_ejecutivo_490_de_2020.pdf
Source Title
Panama Decreto Ejecutivo 490 de 4 de octubre de 2019, art. 64 (Tasas), Gaceta Oficial Digital 28875-A
Source Effective Date
2019-10-04
Verified On
2026-08-25
Id
operating-licence-distributor
Item
Licencia de Operación - Distribuidor
Currency
PAB
Amount Local
200
Amount Local Formatted
B/. 200
Frequency
Per licence
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://minsa.b-cdn.net/sites/default/files/normatividad/decreto_ejecutivo_490_de_2020.pdf
Source Title
Panama Decreto Ejecutivo 490 de 4 de octubre de 2019, art. 64 (Tasas), Gaceta Oficial Digital 28875-A
Source Effective Date
2019-10-04
Verified On
2026-08-25
Id
operating-licence-retailer
Item
Licencia de Operación - Minorista
Currency
PAB
Amount Local
150
Amount Local Formatted
B/. 150
Frequency
Per licence
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://minsa.b-cdn.net/sites/default/files/normatividad/decreto_ejecutivo_490_de_2020.pdf
Source Title
Panama Decreto Ejecutivo 490 de 4 de octubre de 2019, art. 64 (Tasas), Gaceta Oficial Digital 28875-A
Source Effective Date
2019-10-04
Verified On
2026-08-25
Id
operating-licence-warehouse
Item
Licencia de Operación - Almacén
Currency
PAB
Amount Local
150
Amount Local Formatted
B/. 150
Frequency
Per licence
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://minsa.b-cdn.net/sites/default/files/normatividad/decreto_ejecutivo_490_de_2020.pdf
Source Title
Panama Decreto Ejecutivo 490 de 4 de octubre de 2019, art. 64 (Tasas), Gaceta Oficial Digital 28875-A
Source Effective Date
2019-10-04
Verified On
2026-08-25
Id
operating-licence-update
Item
Actualización de la Licencia de Operación
Currency
PAB
Amount Local
25
Amount Local Formatted
B/. 25
Frequency
Per update
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://minsa.b-cdn.net/sites/default/files/normatividad/decreto_ejecutivo_490_de_2020.pdf
Source Title
Panama Decreto Ejecutivo 490 de 4 de octubre de 2019, art. 64 (Tasas), Gaceta Oficial Digital 28875-A
Source Effective Date
2019-10-04
Verified On
2026-08-25

Notes

Article 64 of Decreto Ejecutivo 490 is the only tasas article in the device regulation, and it prices operating licences alone: the decree fixes no per-device registro sanitario tasa, so the low- and high-risk figures shown are the distributor operating licence that every importer needs regardless of device class.
Ley 90 art. 26 delegates the registro sanitario, free-sale certificate, and GMP/GSP/GDP certificate tariffs to a future executive decree; no such decree has published amounts, so those events carry no verifiable official fee yet.
The balboa is fixed at par with the US dollar and US notes circulate as legal tender, so B/. amounts equal USD amounts.

Last Updated

2026-08-25

Verification Status

official-verified

Official Sources

Title
Panama Decreto Ejecutivo 490 de 4 de octubre de 2019, art. 64 (Tasas), Gaceta Oficial Digital 28875-A
Url
https://minsa.b-cdn.net/sites/default/files/normatividad/decreto_ejecutivo_490_de_2020.pdf
Effective Date
2019-10-04
Accessed Date
2026-08-25
Title
Panama Ley 90 de 26 de diciembre de 2017, art. 26: device tariffs are set by executive decree
Url
https://minsa.b-cdn.net/sites/default/files/general/ley_90_de_26_de_diciembre_2017.pdf
Effective Date
2017-12-27
Accessed Date
2026-08-25

Reviewed On

2026-08-25

Amount Status

exact-current

Range Available

Yes

Additional certifications and licences · 1 record

These country-level records can cover multiple product types. Check each item's scope and conditions before applying a fee, pathway or licence to an IVD.

Open Panama certifications →

Slug

panama

Market

Panama

Confidence

low

Schemes

Id
asep-homologacion-of-wireless-devices
Name
ASEP homologación of telecommunications equipment
Category
Radio Spectrum
Status
Mandatory If Feature
Object
Telecommunications Equipment Or Embedded Radio Module
Note
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.
Source Urls
https://www.asep.gob.pa/wp-content/uploads/telecomunicaciones/resoluciones/anno_8105_telco.pdf
Source Binding
reviewed
Id
iea-reference-laboratory-quality-control-analysis
Name
IEA reference-laboratory quality-control analysis
Category
Product Specific Conformity
Status
Included In Medical Registration
Object
Ivd Or Device Sample
Note
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.
Source Urls
https://www.minsa.gob.pa/contenido/direccion-nacional-de-dispositivos-medicos
Source Binding
candidate

Official Sources

Authority
ASEP (Autoridad Nacional de los Servicios Públicos, Panamá)
Topic
Resolución AN 8105-Telco — homologación scope, mobile-terminal exemption and embedded module inclusion
Url
https://www.asep.gob.pa/wp-content/uploads/telecomunicaciones/resoluciones/anno_8105_telco.pdf
Authority
MINSA (Panama)
Topic
Dirección Nacional de Dispositivos Médicos — Resolución 066/2021 IEA reference laboratory
Url
https://www.minsa.gob.pa/contenido/direccion-nacional-de-dispositivos-medicos

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