Category: First-in-Human

Sponsors still treat Uruguay as a soft Southern Cone add-on: “register after Argentina, same Spanish pack.” That sentence fails on the holder model. Uruguay’s MSP runs a strict single-Local-Holder regime: the Local Holder is the only entity authorised to import the registered device. If two Uruguayan distributors want to sell the same product, each needs its own separate registration. There is no multi-importer shortcut on one certificate.

I am Julio Martinez-Clark, CEO of bioaccess®. This page is the commercial Uruguay file: how a medical device gets onto the Uruguayan market under the Ministerio de Salud Pública (MSP), what Decreto N° 3/008 does for productos médicos, and why manufacturer-funded processing matters when the holder and importer seats are fused. It sits next to our LATAM market-access hub, the Uruguay MSP country page, and the Importer of Record guide. Operator guidance only. Not a quote and not legal advice.

One-sentence answer

Commercial sale in Uruguay requires MSP sanitary registration / venta authorization for the medical product under the device framework operators plan against Decreto N° 3/008, held by a locally enabled Local Holder who is also the only authorised importer for that registration — parallel holders may exist across separate filings, but one certificate does not authorize a second importer.

Two Uruguay desks — do not merge them

Investigational use. Research involving human subjects and device clinical evaluation under instruments such as Decreto 158/019, plus MSP/DIGESA study authorization where required. That file is not a license to sell. Our Uruguay CRO page already separates FIH execution from commercial MSP registration.

Commercial path. Registro and authorization to sell a medical product configuration on the Uruguayan market. The Local Holder on that certificate is the sanitary face and the import face. Downstream commercial relationships can exist; customs and MSP will still look for the holder authorised on the registration.

If your Gantt has one bar labeled “Uruguay MSP,” check whether you are clearing investigational units or commercial stock. Those are two work packages.

What the single-Local-Holder rule actually means

Our live market-access and Importer of Record pages treat Uruguay as one of the most restrictive Southern Cone holder designs:

• The Local Holder is the only entity authorised to import the registered device
• Registration ownership is not divisible across an open importer list
• If two distributors need to market the same product, each files its own separate registration
• Whoever pays for the registration controls it — a distributor that funds the filing can refuse transfer later

That is a different architecture from Colombia (titular with several importers) or Brazil (single detentor who can authorize multiple importadores). Do not copy an INVIMA or ANVISA multi-importer LOI onto Uruguay.

What belongs in the commercial dossier (operator list)

Exact MSP forms and DIGESA / Evaluación de Tecnología checklists move with current practice. The working stack sponsors assemble before Spanish production starts is stable:

• Device identity, intended use, and risk class as Uruguay will see it
• Manufacturer and manufacturing sites, with quality-system evidence appropriate to class
• Technical evidence already used for FDA or CE, mapped to the Uruguayan petition — not dumped as a zip of US folders
• Labels and IFU in Spanish for the configuration you will sell
• Local Holder appointment, representante legal, and director técnico documentation as the current MSP forms require
• Import story that matches the Local Holder — Uruguay fuses holder and importer on the commercial certificate
• Tecnovigilancia / post-market ownership under the holder while the product remains on the market

Public MSP trámite materials describe online initiation, product-type forms, and arancel payment for registro / autorización de venta. Confirm the live form codes for your product type before translators start. Electrical/EMC or RF homologation for wireless devices, when required, runs through Uruguay’s telecom authority as a separate vendor track.

What this file is not

• It is not a clinical-trial authorization under Decreto 158/019 or a FIH ethics pack.
• It is not MERCOSUR mutual recognition that invents one shared registration with Argentina, Brazil, or Paraguay. National MSP registro still sits on its own petition.
• It is not on the published bioaccess® two-part price list. The live Uruguay country page sells manufacturer-funded registration processing because the Local Holder must also be the importer.

How bioaccess® runs the Uruguay seat

On the live market-access offer, bioaccess® processes your MSP registration funded by you, the manufacturer — dossier, translations, agency liaison — while the Local Holder / importer face is structured with transfer-upon-demand clauses in the distribution agreement (reviewed by local counsel). Uruguay is not on the published two-part price list; scope and timeline are confirmed at proposal. We do not invent a statutory day-count here.

Operator checklist before you open a Uruguay MSP folder

1. Write “trial” and “commercial” on two pages if you still need human data in Uruguay.
2. Decide the Local Holder before you pick a second distributor — a second commercial partner usually means a second registration.
3. Confirm manufacturer-funded processing so the channel does not own the certificate by default.
4. Align Spanish labels and IFU to the sellable configuration.
5. Name representante legal and director técnico owners on the local entity paperwork.
6. Budget telecom / RF tracks separately when the device is wireless.
7. If Argentina or Brazil is already on the launch list, do not assume Uruguay rides the same holder architecture.

Talk with bioaccess® when you need Uruguay MSP registration processed without handing the certificate to the first distributor — or when you are sequencing a Uruguay FIH into a later commercial file without mixing the desks.

Sponsors still write “Dominican Republic registration” as if DIGEMAPS were a customs stamp you buy after you pick a local reseller. It is not. A DIGEMAPS-licensed Dominican establishment has to file the registration under a power of attorney from the product owner, and that local establishment is the importer of record. DIGEMAPS’s device procedures separate the titular (the product owner) from the local representative, and they let the titular authorize co-distributors. If the distributor funds the filing and is named as titular, it usually controls the number.

I am Julio Martinez-Clark, CEO of bioaccess®. This page is the commercial Dominican Republic file: how a medical device gets onto the market under DIGEMAPS (Dirección General de Medicamentos, Alimentos y Productos Sanitarios), what Decreto 82-15 and Decreto 246-06 actually do, and why the Authorized Representative seat is the decision you make before you sign an exclusive LOI. It sits next to our LATAM market-access hub, the DIGEMAPS country page, the Importer of Record guide, and our guide to titular, representative and co-distributors in the Dominican Republic. Operator guidance only. Not a quote and not legal advice.

One-sentence answer

Commercial sale in the Dominican Republic requires a DIGEMAPS sanitary registration, filed by a licensed Dominican establishment under a power of attorney from the product owner, under Ley 42-01, Decreto 246-06 (a medicines regulation that DIGEMAPS applies to productos sanitarios) and DIGEMAPS’s published procedures. A foreign manufacturer cannot file or import on its own, but DIGEMAPS’s device procedures let the product owner appear as titular with a local representative, add co-distributors by power of attorney, and change the representative or the titular through separate DIGEMAPS procedures.

Two Dominican desks — do not merge them

Investigational use. Ethics and clinical-research authorization for first-in-human or other device studies in the Dominican Republic. That file is not a license to sell. Keep trial import and commercial freight on separate accountability logs.

Commercial path. Manufacture, import, commercialization, or distribution of a device configuration you intend to sell. DIGEMAPS is the sanitary authority for that track. A licensed local representative files and imports. More than one licensed Dominican company can be authorized under one registration through DIGEMAPS’s co-distributor procedure, but only with a power of attorney from the titular.

If your Gantt has one bar labeled “DIGEMAPS,” check whether you are asking for a trial petition or a selling license. Those are two work packages.

What Decreto 82-15 and Decreto 246-06 actually do

Decreto 82-15 created DIGEMAPS by merging the prior Drugs/Pharmacies and Food Risk Control directorates. It is the institutional home of the device sanitary file today — not a synonym for “MISPAS paperwork” generically.

Decreto 246-06 is the substantive rule set operators plan against for registration, import, distribution, and post-market duties. Do not invent a second Dominican statute number for a board slide. Plan against those instruments and current DIGEMAPS practice, and confirm forms before translators start.

Decreto 246-06 is written for medicines and has no device chapter, but DIGEMAPS lists it as the legal basis for registering productos sanitarios. A device-specific Reglamento de Productos Sanitarios y/o Dispositivos Médicos was published as a draft in January 2025; it is not in force. Changing the representative or the titular is a DIGEMAPS procedure, not a private vendor swap, and each change runs on a power of attorney from the titular. See titular, representative and co-distributors in the Dominican Republic for the documents each procedure asks for.

What belongs in the commercial dossier (operator list)

Exact DIGEMAPS forms move with current practice. The working stack sponsors assemble before Spanish production starts is stable:

• Device identity, intended use, and the risk level you declare in the dossier. No binding device class scheme is in force today; Classes I, IIa, IIb and III come from the January 2025 draft regulation, which is not in force. Do not paste a US Class II memo
• Manufacturer and manufacturing sites, with quality-system evidence appropriate to class
• Technical evidence already used for FDA or CE, mapped to the DIGEMAPS petition — not dumped as a zip of US folders
• Labels and IFU in Spanish for the configuration you will sell
• Power of attorney from the product owner to the licensed local representative, and that establishment’s DIGEMAPS registration
• Import story that matches the licensed representative or authorized co-distributor named on the registration — not a freight forwarder with a borrowed tax ID
• Post-market ownership agreed between the titular and the local representative

Operators also treat local trademark readiness (ONAPI) as a pre-file gate on many Dominican device petitions. Confirm the live DIGEMAPS checklist for your SKU before you pretend the sanitary clock has started. Electrical/EMC or RF homologation for wireless devices, when required, runs through the Dominican telecom authority as a separate vendor track. Do not bury that inside the DIGEMAPS sanitary clock.

What this file is not

• It is not a clinical-trial authorization. Trial units and commercial units follow different petitions.
• It is not “the distributor will handle registration.” If the distributor pays for the filing and is named as titular, it controls market access until DIGEMAPS approves a change of titular, and that change needs the original certificate and transfer documents from the current titular.
• It is not an FDA or CE equivalence stamp. Prior clearances help the technical story; they do not replace DIGEMAPS registro for a commercial SKU.

How bioaccess® runs the Dominican seat

On the live market-access offer, bioaccess® sells DIGEMAPS registration processing funded by the manufacturer — dossier, translations, agency liaison, and hostage-proof contracting language for the distribution agreement — while a DIGEMAPS-licensed Dominican establishment acts as representative and importer under a structure that can change on demand. bioaccess® does not act as registration holder, representative or importer of record in the Dominican Republic. DIGEMAPS publishes a response time of 90 working days per registration application; that is a service target, not a guaranteed approval date.

Operator checklist before you open a DIGEMAPS folder

1. Write “trial” and “commercial” on two pages if you still need human data in the Dominican Republic.
2. Decide who is titular and who is the local representative before you sign an exclusive distribution LOI.
3. Confirm who pays for the filing — manufacturer-funded processing is how you keep control of the certificate.
4. Align Spanish labels and IFU to the sellable configuration, not an investigational kit.
5. Confirm ONAPI / trademark readiness and any DIGEMAPS pre-file checklist items for your class.
6. Budget telecom / RF tracks separately when the device is wireless.
7. Write the transfer-upon-demand clause with local counsel before the first commercial shipment.

To start, send your IFUs, your SKU list and your current certificates through our contact page. For the titular, representative and co-distributor rules, read titular, representative and co-distributors in the Dominican Republic.

Sponsors still treat Peru as “find a droguería and hope DIGEMID likes the dossier.” That sentence mixes three seats: the titular on the sanitary registration, the importer that holds a CRS / droguería license, and the commercial distributor that wins hospital tenders. Decreto Supremo N° 001-2024-SA is what lets you keep the first seat independent of the second and third.

I am Julio Martinez-Clark, CEO of bioaccess®. This page answers the market-access question — how a medical device gets onto the Peruvian market under DIGEMID (Dirección General de Medicamentos, Insumos y Drogas) — and how an independent Peru Registration Holder (PRH) keeps channel changes from becoming a new registration project. It sits next to our LATAM market-access hub, the Peru DIGEMID country page, and the Importer of Record guide. Operator guidance only. Not a quote and not legal advice.

One-sentence answer

Commercial sale in Peru requires DIGEMID sanitary registration held by a locally enabled titular, with imports flowing through a licensed droguería — and under Decreto Supremo N° 001-2024-SA an independent Peru Registration Holder can sit separate from the distributor, while additional droguerías can obtain their own CRS to import a product already registered by another titular.

Three Peru seats — write them on separate pages

Titular / PRH. The sanitary face of the device on the DIGEMID file. This is who answers for the registration and for tecnovigilancia obligations under DS 013-2014-SA (named Responsable de tecnovigilancia, DIGEMID-format incident reports, corrective actions, distribution list). If that system fails, DIGEMID can fine (published ceilings reference UIT units) and suspend or cancel the registration. A device without a live registration cannot legally stay on the market.

Importer / droguería. Licensed storage and import capacity. Additional droguerías can, under the 001-2024-SA model described on our live Peru page, obtain their own CRS to import a product already registered by another titular — which is why an independent PRH is useful and a distributor-titular is expensive to unwind.

Commercial distributor. Sales, tenders, and field relationships. This seat should not own the sanitary number if you want the option to change channel later.

If your LOI makes the first Peruvian distributor the titular “to keep it simple,” you have not simplified. You have priced a future cesión into the deal.

What belongs in the commercial dossier (operator list)

Exact DIGEMID forms move with current practice. The working stack sponsors assemble before translators start is stable:

• Device identification, intended use, and risk class as DIGEMID will see it
• Manufacturer and manufacturing sites, with quality-system evidence appropriate to class (ISO 13485 is the practical language)
• Technical file / essential-requirements evidence already used for FDA or CE, mapped to the Peruvian petition — not dumped as a zip of US folders
• Labels and IFU in Spanish for the configuration you will sell
• Independent PRH appointment and local entity documentation
• Importer / droguería CRS story that matches who will physically import — which may be more than one licensed actor over the life of the registration
• Tecnovigilancia ownership under the holder, with a named Responsable de tecnovigilancia on file

Electrical/EMC or RF homologation for wireless devices, when required, runs through Peru’s telecom authority as a separate vendor track. Do not bury that inside the DIGEMID sanitary clock.

What this file is not

• It is not a clinical-trial authorization. First-in-human and other investigational use follow a different petition set.
• It is not “the distributor will handle registration.” Under 001-2024-SA you can — and usually should — keep PRH independent of the commercial channel.
• It is not a free pass from tecnovigilancia. Holding the number without the Responsable and the DIGEMID reporting clocks is how registrations die after launch.

How bioaccess® runs the Peru holder seat

On the live market-access offer, bioaccess® acts as the neutral Peru Registration Holder under contract with you, working with our local partner, for sanitary registration, importer-of-record coordination under the droguería pathway, and sworn translations, with tecnovigilancia as holder. Pricing is two-part: a one-time registration fee, then an annual holder fee from year 2, as published on bioaccessla.com/market-access. Timelines are confirmed at proposal against the current DIGEMID queue — we do not invent a statutory day-count here.

Operator checklist before you open a Peru registro folder

1. Write “titular,” “droguería/importer,” and “distributor” on three pages. Put owners and statutes on each page.
2. Decide the independent PRH before you sign an exclusive distribution LOI.
3. Confirm the configuration you will sell matches the labels and IFU you will file — not an investigational configuration from an FIH.
4. Map FDA/CE evidence to the DIGEMID petition; do not ship the US zip as the dossier.
5. Name the Responsable de tecnovigilancia and the complaint-forwarding clock from the US system into Peru before first commercial shipment.
6. Budget how a second droguería would obtain its own CRS if you add a second importer later — that is the point of 001-2024-SA.

Talk with bioaccess® when you need Peru registro held independent of the commercial channel — or when you are sequencing a Peru FIH into a later DIGEMID market file without mixing the desks.

Sponsors still write “Chile registration” as if ISP ran a single on/off switch. It does not. Some device categories already need sanitary registration. Many others still enter through a Certificado de Destinación Aduanera (CDA). Decreto Exento No. 25 of 2026 is expanding the mandatory list on a staged calendar — and Boletín 17.375-11, the broader risk-based reform bill, is not law yet.

I am Julio Martinez-Clark, CEO of bioaccess®. This page is the commercial Chile file: how a medical device gets onto the Chilean market under the Instituto de Salud Pública (ISP), when CDA is still enough, and how Decreto Exento No. 25 changes the planning calendar. It sits next to our LATAM market-access hub, the Chile ISP country page, and the Importer of Record guide. Operator guidance only. Not a quote and not legal advice.

One-sentence answer

Commercial sale in Chile requires ISP sanitary registration when your device category is under the sanitary-control regime of Article 111 of the Código Sanitario and Decreto Supremo No. 825 of 1998 — including the 39 categories Decreto Exento No. 25 of 6 March 2026 (Diario Oficial 19 March 2026) is pulling in on 24- and 36-month transition dates — while devices still outside a mandatory category typically import under a CDA until their category’s clock starts.

Two Chile desks — do not merge them

Investigational use. Ethics and clinical-research authorization for first-in-human or other device studies. That file is not a license to sell. Chile’s ethics timing and ISP research facts live on our Chile FIH / ethics pages, not on this commercial brief.

Commercial path. Manufacture, import, commercialization, or distribution of a device that already has a clearance story elsewhere (often FDA or CE). For categories already under sanitary control — and for categories Decreto Exento No. 25 will make mandatory after their transition dates — the conformity verification for that purpose is an ISP registro sanitario. For devices not yet in a mandatory category, ISP and Aduanas still use the CDA pathway for customs destination of unregistered devices.

If your Gantt has one bar labeled “ISP,” check whether the product is on a mandatory list today, on Decreto Exento No. 25’s 2028/2029 waves, or still CDA-only. Those are three different work packages.

What Decreto Exento No. 25 actually does

Published in the Official Gazette on 19 March 2026 (CVE 2781436), Decreto Exento No. 25 incorporates listed medical devices and IVDs into the sanitary-control regime under Article 111 of the Código Sanitario and DS No. 825/1998. Once each category’s transitional date arrives, those products may only be manufactured in Chile, imported, marketed, or distributed if they hold the corresponding ISP sanitary registration.

Planning anchors from the decree and the public transition tables operators are using in 2026:

• Technical instructives / complementary resolutions — target window within about 12 months of publication (around March 2027)
• Higher-risk / implantable wave — about 24 months (around 19 March 2028) for the first listed group
• Equipment, IVDs, SaMD, and remaining listed categories — about 36 months (around 19 March 2029)
• Voluntary early filing — the decree allows voluntary ISP registro before a category’s mandatory date once the instructivo técnico exists

Do not treat those dates as “we can ignore Chile until 2028.” Distributor selection, Spanish labeling, and holder appointment take longer than a board slide admits — and voluntary early registro is often the cleaner commercial story for US/EU manufacturers already shipping into Chile under CDA.

Boletín 17.375-11 is not the current rule

The broader bill that would move Chile toward open-ended, risk-based device authorization and put recognition of foreign approvals on a clearer statutory footing is Boletín 17.375-11. It is still a bill. Plan against Decreto Exento No. 25, DS No. 825/1998, and current ISP practice. Do not promise a board that Chile already runs a full IMDRF-style reliance regime for every class.

What belongs in the commercial dossier (operator list)

Exact ISP forms and instructivos move with ANDIM practice. The working stack sponsors assemble before translators start is stable:

• Device identity, intended use, and whether the product sits in a mandatory category today or on a Decreto Exento No. 25 wave
• Manufacturer and manufacturing sites, with quality-system evidence appropriate to the claimed category
• Technical evidence already used for FDA or CE, mapped to ISP’s petition — not dumped as a zip of US folders
• Labels and IFU in Spanish for the configuration you will sell
• Local legal entity / holder documentation — Chile’s commercial face of the file
• A written CDA-versus-registro decision for every SKU you intend to import before its mandatory date

Electrical/EMC or RF homologation for wireless devices, when required, runs through Chile’s telecom authority (SUBTEL) as a separate vendor track. Do not bury that inside the ISP sanitary clock.

What this file is not

• It is not a clinical-trial authorization. Trial units and commercial units follow different petitions.
• It is not a CDA forever. A CDA for an unregistered device is not a substitute for ISP registro once the category is mandatory.
• It is not Boletín 17.375-11. Do not sell “future recognition of FDA” as today’s pathway.

How bioaccess® handles Chile registration

On the live Chile ISP market-access page, bioaccess® processes your registration funded by you (dossier, translations, agency liaison) and sells registration processing there, not a holder subscription: in Chile the titleholder must also be the importer, so there is no annual holder fee. Chile is quoted case by case and is not part of the fixed-price plan. Timelines on the Chile page are typically 30–90 days experience-based planning ranges once the dossier is ready — confirmed at proposal against the current ISP queue. We do not invent a statutory day-count here.

Operator checklist before you open a Chile registro folder

1. Map every SKU to mandatory-today, Decreto Exento No. 25 wave (2028/2029), or CDA-only.
2. Write “trial” and “commercial” on two pages if you still need human data in Chile.
3. Decide the local holder before you pick a distributor.
4. Confirm the sellable configuration matches Spanish labels and IFU — not an investigational configuration.
5. Budget SUBTEL / RF tracks separately when the device is wireless.
6. If you are already selling under CDA into a category on the 2028/2029 waves, decide whether voluntary early registro is cheaper than a scramble later.

Talk with bioaccess® when you need Chile registro held independent of the commercial channel — or when you are sequencing a Chile FIH into a later ISP market file without mixing the desks.

US MedTech founders ask this in almost every Panama or El Salvador first-in-human (FIH) scoping call: “If we run the early cases outside the US, will FDA take the data for an IDE, 510(k), De Novo, or PMA?”

I am Julio Martinez-Clark, CEO of bioaccess®. Short answer: yes, foreign clinical data can support those files — when you design the study for 21 CFR 812.28 from day one. A fast ethics letter on the wrong protocol is not an FDA asset. This page is the operator cut for Panama and El Salvador. It sits next to our Panama FIH Class III guide, the LATAM vs Australia early-feasibility comparison, and the early feasibility vs pivotal brief. Not a quote and not legal advice.

One-sentence answer

Panama or El Salvador FIH data can enter an FDA strategy when the investigation meets the good clinical practice (GCP) and supporting-information rules in 21 CFR 812.28 — including an inspectable trial file — and when the investigational device is identical to the US device or you submit a detailed comparison.

What 21 CFR 812.28 actually tests

FDA’s foreign-clinical-data rule is not a country whitelist. It asks whether the investigation was conducted under a GCP standard for design, conduct, monitoring, auditing, recording, analysis, and reporting that keeps data credible and protects subjects. That standard includes independent ethics-committee review and approval before initiation, continuing review, and documented freely given informed consent.

FDA has stated that conformance with ISO 14155:2020 will generally satisfy the GCP requirement of 812.28. Investigations initiated on or after 21 February 2019 must conform to the 2018 foreign-data framework. Country of conduct is relevant for import, ethics, and site quality. It is not a substitute for 812.28 design.

Significant-risk devices: build the full 812.28(b) set

For a significant-risk device as defined in 21 CFR 812.3(m) — the Class III / high-risk biomaterial FIH case — plan the full supporting set in 812.28(b):

• Investigators and sites
• Protocol and results
• A statement that the investigational device is identical to the US device, or a detailed comparison of differences
• Valid scientific evidence under 21 CFR 860.7 if you claim safety and effectiveness
• Independent ethics committee (IEC) identity meeting 812.3(t)
• Consent, monitoring, and investigator GCP training documentation

FDA can validate the data through an onsite inspection or other appropriate means. A Panama or El Salvador file that cannot be inspected is not an 812.28 file. Electronic data capture, device accountability, and source documents that survive an English-speaking inspector are part of study design — not a later translation job.

Do not plan to live in 812.28(e)

Section 812.28(e) is the residual clause: even when a foreign study does not fully meet paragraph (a), FDA may still accept the information if it believes the data are credible and accurate and that subject rights were adequately protected. That is a reviewer safety valve. It is not a protocol strategy. Build paragraph (a). Treat (e) as the exception you hope never to need.

Why Panama and El Salvador show up in the same answer

Both countries are used for early device cohorts when sponsors need surgical or hospital volume outside a US IDE queue. Panama’s investigational desk runs under Ley 84 of 2019 and Decreto Ejecutivo No. 21 of 2026 (CNBI-accredited Type II ethics, RESEGIS, parallel MINSA review for higher-risk protocols). El Salvador is often the second country in a multi-country early plan when enrollment or anatomy needs a wider net — the same pattern already described on our Panama FIH guide (Panama plus El Salvador plus Brazil as an example multi-country frame).

For FDA usability, the country pair matters less than whether both sites run one protocol, one monitoring plan, one device configuration, and one TMF standard. Two local “quick starts” with divergent ICFs and unaccounted devices will not stitch into an 812.28 package later.

What makes OUS data fail the FDA conversation

• Protocol written for local approval only, with inclusion, imaging, and device deficiencies redefined after the fact for a US file
• Investigational configuration that quietly differs from the US device without a comparison table
• English-only or incomplete source that cannot support inspection
• Mixing commercial registro (Panama DNDM / Ley 90–Decreto 490) with the trial authorization and assuming market clearance equals clinical evidence
• Hoping 812.28(e) will rescue a study that never ran ISO 14155 discipline

Operator checklist before first patient in Panama or El Salvador

1. Write the US intended use and device configuration on one page. Lock whether the OUS unit is identical or document every difference.
2. Design the protocol once for ISO 14155:2020 monitoring, consent, and SAE clocks — then map local ethics and ministry steps underneath it.
3. Confirm ethics committees meet the independence expectations behind 812.3(t) and keep approval letters in the TMF.
4. Build EDC, device accountability, and source so an FDA inspector can follow a subject without a scavenger hunt.
5. Keep commercial registro off the FIH critical path. Trial authorization is not a license to sell.

Talk with bioaccess® when you need a Panama or El Salvador FIH framed so the same dataset can later support an IDE conversation or a marketing submission under 21 CFR 812.28 — without inventing a country whitelist FDA does not publish.

Sponsors keep mixing two Panama desks into one email: “we need MINSA for our device.” One desk is commercial registro sanitario. The other is clinical-research authorization. They are not the same petition, and swapping them mid-cycle is how a quarter disappears.

I am Julio Martinez-Clark, CEO of bioaccess®. This page answers the market-access question — how a medical device gets onto the Panamanian market under MINSA’s Dirección Nacional de Dispositivos Médicos (DNDM) — and how that file stays off the first-in-human critical path. It sits next to our LATAM market-access hub, the Importer of Record guide, and the Panama FIH device guide. Operator guidance only. Not a quote and not legal advice.

One-sentence answer

Commercial sale in Panama is a sanitary-registration file under Ley 90 of 26 December 2017 (as modified by Ley 92 of 12 September 2019) and Decreto Ejecutivo No. 490 of 4 October 2019, with DNDM as the classifying authority and a single Authorized Representative as the regulatory anchor. A MINSA/CNBI trial authorization is not a license to sell.

Two MINSA desks — write them on separate pages

Investigational use. Protocol review under Ley 84 of 14 May 2019 and Decreto Ejecutivo No. 21 of 23 April 2026 (Gaceta Oficial No. 30510-C), with ethics at a CNBI-accredited Type II committee and RESEGIS registration before start. That path is for first-in-human and other clinical research. See the Decreto 21 explainer.

Commercial registro. Sale and distribution of a medical device that already has a clearance story elsewhere (often FDA or CE) follows Ley 90 / Ley 92 and Decreto 490. Risk class for registro sanitario follows current GHTF/IMDRF rules; DNDM classifies. The named Authorized Representative is the regulatory face of the product and, in Panama’s single-representative model, the importer-of-record anchor.

If your Gantt has one bar labeled “MINSA,” you do not have a plan. You have a hope.

What the single Authorized Representative model means

Panama is a single-representative market. The representative on the registro is the sanitary face of the device. Changing that name is closer to a new market entry than a contract amendment — the same pattern we describe for other single-AAR Central American markets on the independent registration-holder strategy page.

Design implication for US and European manufacturers: do not put the commercial distributor on the certificate if you want the option to change channel later. Hold titularidad with an entity that answers to the manufacturer’s transfer doctrine — then authorize distributors underneath that holder.

What belongs in the commercial dossier (operator list)

Exact forms and annexes move with DNDM practice. The working stack sponsors assemble before translators start is stable:

• Device identification, intended use, and GHTF/IMDRF risk class as DNDM will see it
• Manufacturer and manufacturing sites, with quality-system evidence appropriate to class
• Technical file / essential-requirements evidence already used for FDA or CE, mapped to the Panamanian petition — not dumped as a zip of US folders
• Labels and IFU in Spanish for the configuration you will sell
• Authorized Representative appointment and local entity documentation
• Tecnovigilancia ownership under the holder, not under whichever distributor won the first tender

Electrical/EMC or RF homologation for wireless devices, when required, runs through Panama’s telecom authority as a separate vendor track. Do not bury that inside the sanitary clock.

What this file is not

• It is not a substitute for Decreto 21 ethics + MINSA research review when you still need human data.
• It is not an investigational import permit. Trial units enter under the research authorization; commercial units enter under registro.
• It is not a free pass to use a Panama FIH as proof of market clearance. First patient in and registro sanitario are different end states.

How bioaccess® handles Panama registration

On the live Panama MINSA market-access page, bioaccess® processes your registration funded by you (dossier, translations, agency liaison) and sells registration processing there, not a holder subscription: in Panama the titleholder must also be the importer, so there is no annual holder fee. Panama is not on the published-pricing list (Mexico, Colombia, Brazil, Peru and Argentina) and is quoted case by case. Timelines are confirmed at proposal against the current DNDM queue — we do not invent a statutory day-count here.

Operator checklist before you open a Panama registro folder

1. Write “trial” and “registro” on two pages. Put owners and statutes on each page.
2. Decide the Authorized Representative before you pick a distributor.
3. Confirm the configuration you will sell matches the labels and IFU you will file — not the investigational configuration from an FIH.
4. Map FDA/CE evidence to the DNDM petition; do not ship the US zip as the dossier.
5. Budget tecnovigilancia and holder change cost as part of channel design, not as a later surprise.

Talk with bioaccess® when you need Panama registro held independent of the commercial channel — or when you are sequencing a Panama FIH under Decreto 21 into a later DNDM market file without mixing the desks.