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Category: Regulatory Affairs

  • PharmaLex MedTech Local Affiliate Services vs bioaccess® LATAM Registration Holder

    PharmaLex (Cencora) shows up when manufacturers search for a Latin American registration holder or sanitary-registration partner. This article uses only what PharmaLex (Cencora) publishes on its own site (www.pharmalex.com/pharmalex-industry-sectors/medtech · www.pharmalex.com/pharmalex-solutions/local-affiliate-services), then compares it with the multi-country subscription from bioaccess®. It is a practitioner comparison, not a teardown.

    What PharmaLex (Cencora) publishes

    PharmaLex, part of Cencora, is a global regulatory consultancy that says it has 60+ offices in 32 countries. Its MedTech page says it arranges authorized-representative services in "multiple markets" and manages the product licenses, and its local-affiliate page names emerging Latin American markets "such as Brazil and Mexico." The public pages do not list INVIMA, ANMAT, ISP or DIGEMID holder services one by one, and much of the MedTech content is EU MDR/IVDR work.

    PharmaLex (Cencora) vs bioaccess®

    Dimension PharmaLex (Cencora) bioaccess®
    Public product Global MedTech regulatory consulting, authorized representative / license holder arranged in multiple markets LATAM Launch Subscription: registration, in-country holder, certified translations, government fees, tecnovigilancia (import shipments quoted separately)
    Geography Brazil and Mexico named; others not enumerated 19 LATAM markets
    Public pricing Enterprise / statement of work USD 7,500 per year per country for the first device family
    Holder vs distributor Says that, as a specialist market representative, it keeps distribution arrangements independently structured Holds through its own in-country entities, with defined transfer provisions; the registration is never leverage
    Bridge from a clinical trial None published Trial-to-Market Bridge: 20% off for bioaccess® clinical-trial clients

    Where each one fits

    If you are a large manufacturer already buying EU MDR and pharmacovigilance work from PharmaLex, adding Brazil or Mexico through the same account is fine.

    The LATAM Launch Subscription from bioaccess® is a different product. bioaccess® registers already FDA-cleared or CE-marked devices and holds them through its own in-country entities across 19 Latin American markets, including COFEPRIS, ANVISA, INVIMA, ANMAT, ISP and DIGEMID. The published card is USD 7,500 per year per country for the first device family, with government submission fees, certified or sworn translations, the in-country titular or holder, and tecnovigilancia inside the fee (importer-of-record shipments are priced separately on the hub). Multi-country discounts are 10% at three or more countries and 15% at five or more. The registration is held for the manufacturer’s benefit, with defined transfer provisions if you ever change partners or set up your own entity.

    One country and one local partner is enough? Hire the firm that publishes that job. Several LATAM labels under one holder who is not your distributor? Start at bioaccess® market access, read the LATAM importer of record guide, try the LATAM Launch Calculator, or request a registration quote.

    Competitor facts from the PharmaLex (Cencora) public pages linked above, reviewed for bioaccess® competitive research (Aug 2026–Nov 2026). Claims are theirs. No invented clients, prices or contacts.

  • Registrar Corp / CMC Global Representation vs a LATAM Registration Holder (bioaccess®)

    Registrar Corp (CMC Medical Devices) shows up when manufacturers search for a Latin American registration holder or sanitary-registration partner. This article uses only what Registrar Corp (CMC Medical Devices) publishes on its own site (www.registrarcorp.com/medical-devices/global-representation · www.registrarcorp.com/contact/mexico-office), then compares it with multi-country market access from bioaccess®. It is a practitioner comparison, not a teardown.

    What Registrar Corp (CMC Medical Devices) publishes

    Registrar Corp is a long-standing U.S. FDA-compliance firm that works with CMC Medical Devices on global representation. Its representation page lists Europe, the UK, Switzerland, Australia, China, the US, India, Korea, Southeast Asia and "South America." We found no country pages naming ANVISA, COFEPRIS, INVIMA or ANMAT holder services. Registrar Corp does publish a Mexico office contact page.

    Registrar Corp (CMC Medical Devices) vs bioaccess®

    Dimension Registrar Corp (CMC Medical Devices) bioaccess®
    Public product Global authorized-representative network; Latin America described as "South America" Registration, in-country holder, certified translations, tecnovigilancia as holder (import shipments quoted separately)
    Geography "South America" (no Latin American regulator named on the page) Published pricing in Mexico, Colombia, Brazil, Peru and Argentina; other markets quoted case by case
    Public pricing None published for Latin America Two-part: one-time registration fee per country by class, then an annual holder fee from year 2 (rate card)
    Holder vs distributor See the provider’s own terms Holder under contract (own Colombian entity in Colombia; local partner elsewhere), with defined transfer provisions; the registration is never leverage
    Bridge from a clinical trial None published Same firm can run the LATAM clinical trial and then hold the commercial registration

    Where each one fits

    If you need one vendor for US Agent, EU, UK, Swiss and Asian representation and Latin America is a later thought, Registrar Corp is a reasonable global bundle.

    bioaccess® market access is a different product. bioaccess® registers already FDA-cleared or CE-marked devices and acts as their registration holder under contract (in Colombia through its own Colombian entity; elsewhere with its local partner) across Latin American markets, including COFEPRIS, ANVISA, INVIMA, ANMAT, ISP and DIGEMID. Pricing is two-part pricing: a one-time registration fee per country by device class, then a lower annual holder fee from year 2 (published for Mexico, Colombia, Brazil, Peru and Argentina on the rate card). Importer-of-record shipments are quoted separately. The registration is held for the manufacturer’s benefit, with defined transfer provisions if you ever change partners or set up your own entity.

    One country and one local partner is enough? Hire the firm that publishes that job. Several LATAM labels under one holder who is not your distributor? Start at bioaccess® market access, read the LATAM importer of record guide, try the market-access calculator, or request a registration quote.

    Competitor facts from the Registrar Corp (CMC Medical Devices) public pages linked above, reviewed for bioaccess® competitive research (Aug–Oct 2026). Claims are theirs. No invented clients, prices or contacts.

  • Global Regulatory Partners Brazil and Mexico Registration Holder vs bioaccess®

    Global Regulatory Partners (GRP) shows up when manufacturers search for a Latin American registration holder or sanitary-registration partner. This article uses only what Global Regulatory Partners (GRP) publishes on its own site (globalregulatorypartners.com/registration-holder-for-medical-devices-imported-from-mexico · globalregulatorypartners.com/countries/brazils-anvisa), then compares it with the multi-country subscription from bioaccess®. It is a practitioner comparison, not a teardown.

    What Global Regulatory Partners (GRP) publishes

    Global Regulatory Partners (GRP) is a Massachusetts regulatory firm with affiliates in China, Japan, Brazil and Mexico. Its public pages say GRP-Brazil is licensed by ANVISA to act as Brazilian Registration Holder, and that GRP Mexico is COFEPRIS-licensed to act as Mexico Registration Holder and local representative. The Mexico page pitches an independent holder, so a manufacturer can add distributors without handing them the dossier, and also lists importation, warehousing and distribution.

    Global Regulatory Partners (GRP) vs bioaccess®

    Dimension Global Regulatory Partners (GRP) bioaccess®
    Public product ANVISA BRH and COFEPRIS MRH through its own licensed affiliates; Mexico import, warehousing, distribution LATAM Launch Subscription: registration, in-country holder, certified translations, government fees, tecnovigilancia (import shipments quoted separately)
    Geography Brazil and Mexico 19 LATAM markets
    Public pricing None published USD 7,500 per year per country for the first device family
    Holder vs distributor GRP Mexico files as primary holder and adds the manufacturer's distributors to the registration without giving them control of, or access to, confidential information; a holder transfer needs the original holder's notarized consent Holds through its own in-country entities, with defined transfer provisions; the registration is never leverage
    Bridge from a clinical trial None published Trial-to-Market Bridge: 20% off for bioaccess® clinical-trial clients

    Where each one fits

    If Brazil and Mexico are the only Latin American markets on the plan, and you also want GRP for China or Japan, its own-affiliate model covers that job.

    The LATAM Launch Subscription from bioaccess® is a different product. bioaccess® registers already FDA-cleared or CE-marked devices and holds them through its own in-country entities across 19 Latin American markets, including COFEPRIS, ANVISA, INVIMA, ANMAT, ISP and DIGEMID. The published card is USD 7,500 per year per country for the first device family, with government submission fees, certified or sworn translations, the in-country titular or holder, and tecnovigilancia inside the fee (importer-of-record shipments are priced separately on the hub). Multi-country discounts are 10% at three or more countries and 15% at five or more. The registration is held for the manufacturer’s benefit, with defined transfer provisions if you ever change partners or set up your own entity.

    One country and one local partner is enough? Hire the firm that publishes that job. Several LATAM labels under one holder who is not your distributor? Start at bioaccess® market access, read the LATAM importer of record guide, try the LATAM Launch Calculator, or request a registration quote.

    Competitor facts from the Global Regulatory Partners (GRP) public pages linked above, reviewed for bioaccess® competitive research (Aug 2026–Nov 2026). Claims are theirs. No invented clients, prices or contacts.

  • THEMA Local Representative and License Holder vs bioaccess® LATAM Market Access

    THEMA shows up when manufacturers search for a Latin American registration holder or sanitary-registration partner. This article uses only what THEMA publishes on its own site (www.thema-med.com/en/services/local-representative-and-license-holder · www.thema-med.com/en/medical-device-registration-argentina), then compares it with the multi-country subscription from bioaccess®. It is a practitioner comparison, not a teardown.

    What THEMA publishes

    THEMA is an Italy-based medical-device consultancy. Its local representative and license holder service page names three Latin American roles it offers: Brazilian Registration Holder (BRH), Mexican Registration Holder (MRH), and Argentina Authorized Representative (AAR). It also publishes a Peru registration explainer that describes the DIGEMID local holder. THEMA offers local representation and license holding "where required" as part of a wider EU authorized-representative network. Its Argentina page warns that changing the AAR means restarting the registration, which is the honest description of how ANMAT works.

    THEMA vs bioaccess®

    Dimension THEMA bioaccess®
    Public product Local representative / license holder in Brazil, Mexico and Argentina, inside an EU AR network LATAM Launch Subscription: registration, in-country holder, certified translations, government fees, tecnovigilancia (import shipments quoted separately)
    Geography Brazil, Mexico, Argentina named on the service page; Peru explainer 19 LATAM markets
    Public pricing None published USD 7,500 per year per country for the first device family
    Holder vs distributor Its local-representative service says it keeps the manufacturer in full control of its registrations and independent of its distributors; its Argentina page warns that ending the AAR relationship invalidates the registration and restarts the process Holds through its own in-country entities, with defined transfer provisions; the registration is never leverage
    Bridge from a clinical trial None published Trial-to-Market Bridge: 20% off for bioaccess® clinical-trial clients

    Where each one fits

    If you already use THEMA as your EU authorized representative and need one or two of Brazil, Mexico or Argentina, keeping the same vendor is a fair choice.

    The LATAM Launch Subscription from bioaccess® is a different product. bioaccess® registers already FDA-cleared or CE-marked devices and holds them through its own in-country entities across 19 Latin American markets, including COFEPRIS, ANVISA, INVIMA, ANMAT, ISP and DIGEMID. The published card is USD 7,500 per year per country for the first device family, with government submission fees, certified or sworn translations, the in-country titular or holder, and tecnovigilancia inside the fee (importer-of-record shipments are priced separately on the hub). Multi-country discounts are 10% at three or more countries and 15% at five or more. The registration is held for the manufacturer’s benefit, with defined transfer provisions if you ever change partners or set up your own entity.

    One country and one local partner is enough? Hire the firm that publishes that job. Several LATAM labels under one holder who is not your distributor? Start at bioaccess® market access, read the LATAM importer of record guide, try the LATAM Launch Calculator, or request a registration quote.

    Competitor facts from the THEMA public pages linked above, reviewed for bioaccess® competitive research (Aug 2026–Nov 2026). Claims are theirs. No invented clients, prices or contacts.

  • IzzoMed Peru Registration Holder vs bioaccess® LATAM Market Access

    IzzoMed is a Lima-based company that now publishes an independent Peru registration holder offer for international medical device, IVD, and pharmaceutical manufacturers. The English page is at izzomed.com/peru-registration-holder/ and the Spanish version is at izzomed.com/es/titular-del-registro-en-peru/. The English holder page went live in late September 2026. This article uses only what IzzoMed publishes, then compares it with multi-country market access from bioaccess®.

    What IzzoMed publishes

    IzzoMed positions itself as a local regulatory representative and registration holder before DIGEMID, Peru’s medicines and devices authority. The holder page lists four parts: local regulatory representation, registration management, registration maintenance (renewals and modifications), and a holder structure that “can remain independent from commercial distribution.” The home page adds importation, storage through authorized healthcare infrastructure, distribution, and commercial development in Peru. IzzoMed also represents specialized oncology equipment in Peru on its own product pages. We found no public price on the site.

    The pitch is the right one for Peru. As summarized in the bioaccess® LATAM registration guide, Decreto Supremo N° 001-2024-SA permits an independent Peru registration holder, and imports still flow through a licensed droguería. A titular that is not the exclusive seller lets the manufacturer change or add distributors without losing the registro.

    IzzoMed vs bioaccess®

    Dimension IzzoMed (Peru) bioaccess®
    Public product Independent Peru registration holder / MAH, plus import, storage, distribution, and commercial support Registration, in-country holder, certified translations, tecnovigilancia as holder (import shipments quoted separately)
    Geography Peru Published pricing in Mexico, Colombia, Brazil, Peru and Argentina, including Peru (DIGEMID); other markets quoted case by case
    Holder vs distributor Says representation can stay separate from a single distributor; also offers distribution and represents its own product lines Holder under contract (own Colombian entity in Colombia; local partner elsewhere), with defined transfer provisions; the registration is never leverage
    Public pricing None published Two-part: one-time registration fee per country by class, then an annual holder fee from year 2 (rate card)
    Bridge from a clinical trial None published Same firm can run the LATAM clinical trial and then hold the commercial registration

    Where each one fits

    If Peru is the only market and the plan is to build a local commercial channel with one partner, IzzoMed’s published offer covers that job, and it says the right things about keeping the titular separate from the seller.

    bioaccess® market access is a different product. bioaccess® registers already FDA-cleared or CE-marked devices and acts as their registration holder under contract across Latin America (in Colombia through its own Colombian entity; elsewhere with its local partner). The bioaccess® Peru Holder covers DIGEMID registration through the licensed droguería pathway, and the same holder doctrine applies next to COFEPRIS, ANVISA, INVIMA, and ANMAT. Pricing is two-part pricing: a one-time registration fee per country by device class, then a lower annual holder fee from year 2 (published for Mexico, Colombia, Brazil, Peru and Argentina on the rate card). Import shipments are quoted separately. The registration is held for the manufacturer’s benefit, with defined transfer provisions if you ever change partners or set up your own entity.

    One country and a local titular is enough? Hire the shop that publishes that job. Several LATAM labels under one holder who is not your distributor? Start at bioaccess® market access, try the market-access calculator, or request a registration quote.

  • LATAM Registration Holder vs Distributor: The License Should Not Be the Channel

    The sanitary registration holder should not be the distributor. Country-by-country IOR rules and why bioaccess® holds registrations under contract (in Colombia through its own Colombian entity; elsewhere with its local partner), without commercial leverage.

    The sanitary registration holder should not be the distributor. That is a design decision — not a branding preference — that determines whether a medical device manufacturer can change channels in Mexico, Brazil, Colombia, or Argentina without redoing the file. This article explains, at the rule level, why the local legal figure and the commercial channel have to live in separate entities, and why the bioaccess® market access exists: to register and sustain an FDA-cleared or CE-marked device under contract (in Colombia through its own Colombian entity; elsewhere with its local partner), without turning the license into commercial leverage.

    What the holder is — and what it is not

    In Latin America the sanitary registration is issued in the name of a legal entity in the country. That entity is the titular, detentor, authorized representative, or holder, depending on the regulator. Technovigilance, responses to the authority, and — in several markets — importation fall on it. The distributor is a different function: it sells, invoices, and services. When both functions sit in the same company, the manufacturer does not have a channel. It has a partner that also owns the regulatory asset. Changing it means a rights assignment, a new registration, or both.

    An independent holder — an own subsidiary or a professional holder that does not commercialize the product — makes it possible to name, add, or remove importers and distributors as each regulation allows. bioaccess® sustains registrations under contract, for the manufacturer’s benefit (in Colombia through its own Colombian entity; elsewhere with its local partner), with assignment defined in the contract. The registration is not leverage. Country-by-country detail: Importer of Record in LATAM.

    Countries with multiple importers on a single registration

    These are the rules bioaccess® publishes in its IOR guide, with primary sources. They are not a consultancy ranking.

    • Mexico (COFEPRIS). The Mexico Registration Holder can name multiple distributors and importers on a single sanitary registration. That is why an independent holder is useful and a distributor-holder is risky. Equivalence pathway for devices already authorized in a reference country (FDA, Health Canada, or Japan); CE marking alone does not qualify. See Mexico — COFEPRIS.
    • Colombia (INVIMA). INVIMA expressly contemplates “one holder with multiple importers.” A Colombian legal face is required and, in practice, an importer with CCAA. The manufacturer does not have to give away title to the first commercializer. See Colombia — INVIMA.
    • Brazil (ANVISA). RDC 751/2022 names a single registration detentor. RDC 270/2019 allows that detentor to authorize multiple importers without re-registering the device. The foreign manufacturer cannot be the detentor. A BRH that is not the exclusive importer is the correct design. See Brazil — ANVISA.
    • Peru (DIGEMID). The holder must be an authorized droguería. Supreme Decree No. 001-2024-SA allows an independent Peru Registration Holder; other droguerías can obtain their own CRS. Again: holder ≠ commercial catalog.
    • Costa Rica (Ministry of Health). Under Decreto N° 34482-S, the Costa Rica Registration Holder (titular) is a distinct legal entity from the importer of record. Multiple importers can be named on one registration, and the titular controls who gets added or removed — the same “license is not the channel” model. The titular must be domiciled in Costa Rica (local entity with cédula jurídica and a Costa Rican digital signature); a foreign manufacturer cannot hold directly.
    • Chile (ISP), today. Most general devices fall outside the mandatory registration list; each importer processes its own CDA per shipment. The holder/authorized representative exists for the types that do register. The pending Fármacos II law will tighten the framework. See Chile — ISP.

    Single registration-importer countries

    In these markets the first holder choice is structural because the holder is the importer, or because the regulation names a single local representative:

    • Argentina (ANMAT). The authorized representative is both holder and importer. One AAR per registration. Disposición 2318/2002 was repealed and replaced by Disposición 64/2025; the single-AAR-importer model remains the commercial fact. Changing AARs usually means re-registering. See Argentina — ANMAT.
    • Ecuador (ARCSA). The certificate is issued in the holder’s name, an Ecuadorian company; a single holder (Resolution ARCSA-DE-026-2016-YMIH, as amended by ARCSA-DE-2023-033-AKRG).
    • El Salvador (SRS). Since August 7, 2024 the Superintendencia de Regulación Sanitaria (successor to DNM) regulates devices; a single local legal representative per registration.
    • Panama (DNDM / MINSA), Dominican Republic (DIGEMAPS), Paraguay (DINAVISA) and several Central American and Caribbean markets: single authorized representative model. Uruguay is not currently in bioaccess®’s published coverage.

    The lesson is not “avoid local consultants.” The lesson is: in a single-IOR market, hosting under a professional holder’s own licenses (or bioaccess®’s entity) is what keeps the channel in the manufacturer’s hands. In a multiple-importer market, the same principle applies — only the mistake shows up later, when the first distributor blocks the second.

    What the bioaccess® service includes — and what we don’t invent

    bioaccess® registers and sustains devices already authorized by FDA (510(k)/PMA) or with CE marking. The service covers the sanitary registration, the holder / importer of record (in Colombia through its own Colombian entity; elsewhere with its local partner), and certified translations into Spanish or Portuguese (sworn where Brazil and Argentina require it). Pricing is two-part pricing: a one-time registration fee per country by device class, then a lower annual holder fee from year 2 (published for Mexico, Colombia, Brazil, Peru and Argentina on the rate card). Public coverage is 19 Latin American and Caribbean markets; there are country pages for Brazil, Mexico, Colombia, Argentina, and Chile. There are no invented prices in this article, no client lists, no third-party emails.

    Two line items are billed separately because no credible party can flatten them: the BGMP plant audit in Brazil and the telecom/EMC-RF homologation for wireless devices. bioaccess® manages them and bills at supplier cost + 20% G&A, per the market access page.

    bioaccess® is not the “single-country holder that also distributes.” It is the multi-country holder that is not the distributor. If the commercial plan is a single market and a local holder with its own entity is enough, that local holder is a valid product. If the plan is multiple seals under the same assignment doctrine, the multi-country holder is the product that matches the rule — not the first result for “registro sanitario + [country].”

    Next step: bioaccess® market access, the importer of record guide, or request a registration quote.

  • Chile’s Easy Market Ends in 2028: Exempt Decree No. 25 and ISP Registration

    Updated October 2026: ISP has not yet issued the technical instruction for Decree No. 25 filings (legal deadline March 19, 2027). This update also corrects the list of products already under mandatory registration and adds the category numbers for each wave.

    Source: This article adapts and expands themes from Julio G. Martinez-Clark’s guest column on Med Device Online (published September 11, 2026): “Chile’s Easy Market Ends In 2028.” Read the full column there; what follows is an original bioaccess® operator brief for manufacturers building a Latin America (LATAM) market-access plan — not a reprint.

    For years, Chile was the LATAM medtech market where a strong distributor and an importer of record (IOR) could often move faster than a full sanitary-registration campaign. Only a short list of named products — latex gloves, condoms, sterile hypodermic needles and syringes, portable automated external defibrillators, HIV in vitro diagnostic (IVD) tests and, more recently, certain blood-bank reagents — required Instituto de Salud Pública (ISP) registration for most commercial paths, according to ISP. In 2021 I asked on Med Device Online how long that “easiest market” window would last. Exempt Decree No. 25 answers it: the easy years run through 2026; the compressed years are 2027–2028.

    What changed: Exempt Decree No. 25

    On March 19, 2026, Chile published Exempt Decree No. 25 in the Diario Oficial (Núm. 44.404, CVE 2781436). The decree pulls 39 numbered medical device and in vitro diagnostic (IVD) types into the sanitary-control regime under Article 111 of the Health Code and Decree Supreme No. 825. ISP describes the set as higher-risk, widely used products tied to ministerial programs, with conformity verification based on quality, safety, and performance documentation.

    The legal machinery was already there — Decree Supreme No. 825 long required conformity-verification certificates for covered devices. Earlier exempt decrees had used that structure for narrow categories (for example sterile hypodermic needles and syringes). The difference now is scale: 39 types, including software as a medical device and multiple IVDs, phased into mandatory ISP sanitary registration.

    Two waves — and why the calendar is not the real clock

    First wave (24 months / 13 types, categories 6 to 18, in Artículo primero transitorio): deadline March 19, 2028. Includes cardiovascular implants and catheters, heart valves, cochlear implants, orthopedic and soft-tissue implants, copper intrauterine devices (IUDs), insulin infusion pumps and accessories, blood bags, and related numbered types in the decree.

    Second wave (36 months / 26 types, categories 1 to 5 and 19 to 39): deadline March 19, 2029. Includes imaging, radiotherapy, dialysis, ventilation, extracorporeal circulation, electrosurgical, ophthalmic, continuous glucose monitoring (CGM), continuous positive airway pressure / bilevel positive airway pressure (CPAP/BPAP), sterilization, oncology software, and several IVD categories.

    Seeing 2028 and assuming “plenty of time” is the first operational mistake. Decree No. 25 gives ISP up to 12 months from publication to issue the technical instruction for conformity verification. Voluntary filing is allowed only after that instruction exists. If the how-to lands near the 12-month mark, manufacturers in the first wave may have roughly one usable year — not two — to interpret requirements, assign ownership, assemble and translate files, close standards gaps, coordinate Chilean partners, submit, answer questions, and obtain registration. That is a compressed portfolio campaign, not a leisurely runway.

    Registration readiness now beats distributor-first strategy

    Chile’s older entry model made distributor selection the first strategic move. After the applicable transition dates, covered products may only be manufactured in Chile, imported, marketed, or distributed with the required conformity verification — which the decree frames as ISP sanitary registration. That shifts bargaining power: if the distributor imports but nobody owns the Chile file, modification path, and continuity if the channel changes, you have built regulatory risk into the sales model.

    Treat this as a LATAM market-access problem, not a one-country paperwork chore. Many manufacturers still use Chile as an early regional entry point because of institutional stability and provider quality. When Chile stops being “import and sell,” the regional launch sequence changes. Map registration and portfolio triage before you lock distribution strategy. (For how bioaccess® packages market-access work, see the market-access rate card — without inventing case-specific rates here.)

    Do not confuse pathways. A clinical-trial authorization or investigational import route is a different file from commercial sanitary registration. It is not 2028 commercial cover. For Chile clinical-operations context, see our Chile clinical trials country page; keep investigational and commercial tracks separate in governance.

    Standards, Spanish dossiers, and postmarket (tecnovigilancia)

    Decree No. 25 points manufacturers toward an explicit standards-based review — including general references such as NCh ISO 16142 (parts 1 and 2), NCh ISO 13485, and NCh ISO 14971, plus product-specific standards for the 39 categories. Chile-ready work is a technical-file readiness exercise, not a local stamp.

    ISP guidance on essential principles of safety and performance already expects devices and IVDs to meet intended performance with risks acceptable relative to benefit, and to ship identification, safety, and use information in castellano (Spanish). Existing FDA, EU MDR, MDSAP, or ISO 13485 packs help — they are not automatically a Chile dossier. Family/group/system filings may not match Chile’s grouping expectations; labels and instructions for use (IFU) may need Spanish updates; legacy lines may have documentation gaps.

    Waiting for ISP’s technical instruction before doing any work wastes the only runway that matters. As of late October 2026, ISP had not issued that technical instruction; the legal deadline is March 19, 2027 (Decreto Exento N° 25, artículos tercero and cuarto transitorios). In early October 2026, ISP published Informational Material No. 1 (Material Informativo N° 1) on the decree: a matrix of the covered categories with in-scope and out-of-scope examples, risk class and transition date. It helps confirm scope. It is not the filing instruction, and voluntary early registration stays closed until that instruction is issued. Final forms can wait; portfolio mapping, standards-gap assessment, Spanish labeling review, and local-role design cannot.

    Postmarket is part of the transition. ISP’s announcement on Decree No. 25 frames the reform as support for postmarket surveillance. Chile already operates tecnovigilancia (technovigilance) enrollment and adverse-event reporting expectations — including precise device identification (lot, model, series, manufacturer, intended use), not generic labels like “catheter” or “valve.” Traceability under related Chilean technical norms belongs in the same operating model as registration. Approval without a Chile-specific complaint, reporting, field-action, and file-sync plan is incomplete market access.

    Five triage moves manufacturers should make now

    1. Map the decree to the live Chile catalog — every model, accessory, software module, kit, and family currently sold, against scope and transition group.
    2. Rank by two-year commercial necessity — some legacy SKUs will not justify registration; platform anchors and consumables drivers often will.
    3. Assess technical-file readiness before the instruction drops — risk management, QMS certificates, Spanish labeling, accessory documentation.
    4. Define local responsibility — who files, maintains, modifies, answers ISP, and owns postmarket vigilance; “the distributor” is an answer only if it protects long-term flexibility.
    5. Budget a multiyear wave — governance, timelines, document owners, escalation — not a one-off filing event.

    What 2021 got right — and what the instruction gap changes

    Directionally, the 2021 Med Device Online column was right: Chile was not going to stay unusually open forever. The vehicle that landed is Decree No. 25 via the Ministry of Health and ISP (with ANDIM in the implementation picture), not the legislative script many watched at the time. Scope is larger than the old four-category mandatory list — 39 numbered types. The underweighted piece in 2021 was the instruction gap: a two-year transition looks generous until the agency has up to a year to write the how-to and early filing is gated on that how-to.

    Chile remains a serious, commercially attractive market with its own regulatory culture. What ended is the assumption that listed device types can enter without a sanitary-registration strategy. Map the catalog now.

    References

    1. Julio G. Martinez-Clark, “Chile’s Easy Market Ends In 2028,” Med Device Online, September 11, 2026 — https://www.meddeviceonline.com/doc/chile-s-easy-market-ends-in-0001
    2. Julio G. Martinez-Clark, “Medtech In Chile: Currently Latin America’s Easiest Market, But For How Long?” Med Device Online — https://www.meddeviceonline.com/doc/medtech-in-chile-currently-latin-america-s-easiest-market-but-for-how-long-0001
    3. Ministerio de Salud de Chile, Decreto Exento N° 25, Diario Oficial March 19, 2026, Núm. 44.404, CVE 2781436 — https://www.bcn.cl/leychile/navegar?idNorma=1222514
    4. Ministerio de Salud de Chile, Decreto Supremo N° 825 — https://www.bcn.cl/leychile/navegar?idNorma=141005
    5. Instituto de Salud Pública de Chile, announcement on the new norm regulating 39 medical devices including IVDs — ISP notice

    Disclaimer: This post is general information for educational and commercial-planning purposes. It is not legal advice and is not a substitute for advice from qualified Chilean counsel or confirmation with ISP on current filing instructions, product classification, or transition applicability to a specific portfolio.

    bioaccess® helps manufacturers sequence LATAM market access — registration ownership, IOR design, and distributor strategy — so Chile’s 2028/2029 waves do not become a last-minute scramble. Contact bioaccess®

  • Compassionate use vs post-trial access in Latin America: do not file the wrong petition

    U.S. teams often arrive in Latin America with one phrase — “compassionate use” or “expanded access” — and expect a single regional petition that keeps patients on product after a trial. That phrase does not map cleanly onto the instruments that actually govern continued supply in the region. Post-trial access (PTA) after an authorized study is usually a different legal object from named-patient / exceptional-import routes. Filing the wrong one produces per-patient dossiers, wrong desks, and gaps at last-patient-last-visit.

    I am Julio Martinez-Clark, CEO of bioaccess®. This page separates those routes using instruments already published on bioaccessla.com — starting with the LATAM post-trial access operator map and the country pillars for Argentina, Brazil, Panama, Chile and Costa Rica. It is not a quote and not legal advice. For operator diligence questions, use how to evaluate a LATAM PTA operator.

    Two problems that share vocabulary

    Write the board question before you ask regulatory for a “compassionate use letter”:

    • Post-trial access (cohort continuity). Identified participants who completed (or still sit in) an authorized clinical trial need continued investigational or successor product because benefit was shown or the statute / ethics framework requires free continuity. The filer is usually the sponsor. The cohort is defined by the trial.
    • Named-patient / exceptional / RAEM-style access. An individual patient outside a trial dossier — or treated as if outside it — needs a medicine or device that is not locally registered, often on a treating physician’s request, with quantity and validity windows that look nothing like a trial extension. The filer is often the patient, family, or a physician — not the sponsor cohort manager.

    U.S. FDA expanded access under 21 CFR 312 Subpart I is a permissive framework for use outside clinical trials. Puerto Rico sits in that U.S. customs picture on our operator map. Most LATAM countries either (a) impose a binding PTA duty after a trial, (b) offer a separate exceptional-import path, (c) soft-route continuation into “compassionate use” language, or (d) impose nothing. Mixing (a) with (b) is the filing error this page exists to prevent.

    Where binding PTA actually sits

    Across the twenty jurisdictions on the operator map:

    • Binding statutory mandate (10): Argentina, Brazil, Chile, Peru, Ecuador, Costa Rica, Guatemala, Honduras, Nicaragua, Panama.
    • Binding instrument, weak or unassigned duty (3): Uruguay, Bolivia, Venezuela — including Venezuela’s BPC “procurar” language and Bolivia’s routing of continuation into per-patient DINAMED compassionate-use authorization.
    • No mandate (7): Mexico, Colombia, Paraguay, El Salvador, Dominican Republic, Cuba, Puerto Rico.

    Colombia’s Resoluciones 2378/2008 and 8430/1993 contain no post-trial supply obligation; Res. 8430 allocates only harm-related costs. Mexico’s NOM-012-SSA3-2012 §11.2.2 is an investigator duty about continued treatment and care, not a sponsor duty to keep shipping investigational product. We do not invent a Colombian PTA petition because a U.S. template says “expanded access.”

    Argentina: the cleanest PTA vs RAEM split

    Argentina is the teaching case because both instruments exist in public text and sponsors still swap them.

    Cohort PTA — Disposición ANMAT 12792/2016. This is the procedure for importing post-study medication, treatment and materials for participants in an ANMAT-authorized clinical pharmacology study. Article 3 requires the sponsor to file eight documents before the study ends. Article 4 gives DERM a twelve-month authorization per investigator and center. Article 3(g) requires a sworn declaration that supply is free to the participant, the treating institution, and the health coverage. Article 2 excludes authorized extension studies — those stay on the trial track. Detail: Argentina Disposición 12792 pillar.

    Named-patient exceptional import — Disposición 4616/2019 (RAEM). The Régimen de Accesibilidad de Excepción a Medicamentos makes no reference to clinical trials. Article 2(a) aims at medicines not registered with ANMAT but registered in an Anexo I country under Decreto 150/92, “destinados a tratar un paciente en particular.” Article 4(a) makes the patient (or family / legal representative) the responsible filer on a treating physician’s prescription and prohibits any gestor or intermediary. Article 12 limits Customs validity to 90 days; quantity caps sit at 90 or 180 days depending on course. Using RAEM for a trial cohort produces one expediente per patient, per renewal, on the wrong legal basis.

    If your Argentine continuation plan is “file RAEM for everyone who responded,” you do not have a PTA plan. You have a stack of individual exceptional imports that a sponsor is not even allowed to manage as gestor.

    Brazil: PTA is statute; compassionate / expanded / post-estudo share a service channel

    Brazil is the strongest PTA mandate in the region and still the easiest place to confuse vocabulary with ANVISA’s assistance-program menu.

    • PTA duty: Lei 14.874/2024 Chapter VI (Arts. 30–37) and Decreto 12.651/2025 Art. 31. The sponsor must file a post-study access plan with the CEP before the trial starts, guarantee free supply when the investigator judges the product the best therapeutic alternative, and may interrupt only on listed Article 33 grounds — including five years counted from commercial availability in Brazil. Ministry of Health / INAEP language: continued treatment “não é uma expectativa, mas um dever legal.” Devices and advanced therapies are in scope through Art. 37. Detail: Brazil Lei 14.874 pillar.
    • Import / assistance mechanics: For medicines, RDC 38/2013 still frames compassionate use, expanded access, and post-study supply as assistance programs. Post-study supply gets “um ofício autorizando o fornecimento,” not a comunicado especial (Art. 3 §2). ANVISA’s own public notice on Consulta Pública 1.210/2023 disclosed that between 2019 and 2023 it received 256 post-study supply requests alongside 558 compassionate use and 41 expanded access requests — three different request types on one service family, not one interchangeable petition.

    Operational takeaway: the CEP-approved PTA program and the ANVISA anuência are not optional synonyms for “compassionate use.” A device sponsor also has a statutory duty under Art. 37 while RDC 38/2013 still speaks in medicamento terms — resolve the post-close import path in the protocol, not at close-out.

    Panama, Chile, Costa Rica: PTA without a U.S.-style expanded-access label

    • Panama — Decreto Ejecutivo 21/2026 Art. 68 (Gaceta Oficial 30510-C, 23 April 2026): investigators and sponsors must ensure participant access when clinical or public-health benefit was shown, until commercialization in the country, via extension of the trial import permit for exclusive participant use. This is not Ley 419 de 2024 (the commercial medicines statute) and not the repealed Decreto Ejecutivo 1843/2014 path. Detail: Panama Decreto 21/2026 pillar.
    • Chile — Código Sanitario Art. 111 C (Ley 20.850): continuity “sin costo para el paciente… por todo el tiempo que persista su utilidad terapéutica,” with the duty following the sanitary-registration holder. That is an open-ended free-supply duty, not a 21 CFR Subpart I-style expanded-access grant. Detail: Chile Ley 20.850 pillar.
    • Costa Rica — Ley 9234 Arts. 28 and 53(k): the clearest express device PTA duty in the region — free post-study provision of “el medicamento, dispositivo o procedimiento,” “mientras lo requieran,” with exhaustive exit conditions. The statute mandates supply; it does not hand you a post-trial import route in Art. 55 (which addresses importation before an approved study begins). Detail: Costa Rica Ley 9234 device PTA pillar.

    Where “compassionate use” language is doing different work

    • Bolivia: the clinical-studies norm routes continuation into the compassionate-use chapter with per-patient DINAMED authorization — a soft/weak PTA posture that is not Brazil’s pre-trial CEP plan.
    • Guatemala: AM 82-2019 Art. 64 is request-driven toward the sponsor; Art. 65 points at compassionate-use authorization by the DRCPFA. That is not automatic cohort PTA.
    • Honduras: Acuerdo 0256-ARSA-2025 Art. 63 creates a new free-supply mandate and names extension trial or compassionate use as routes — read Art. 63 next to Art. 18 numeral 5’s softer “cuando el patrocinador lo considere” language before you equate Honduras with Brazil.
    • United States / Puerto Rico: 21 CFR 312 Subpart I is permissive expanded access, not a LATAM-style sponsor PTA mandate. Do not paste Subpart I templates into an ANMAT 12792 or Panama Art. 68 file.

    Filing mistakes that look like vocabulary errors

    1. RAEM for an Argentine trial cohort. Wrong instrument, wrong filer, wrong quantity clock.
    2. Calling Brazil PTA “compassionate use” in the CEP cover letter. Brazil already distinguishes post-estudo from uso compassivo and acesso expandido in ANVISA request counts and RDC 38/2013 framing.
    3. Citing repealed PTA bases. Argentina Disp. 6677/2010 (repealed by Disp. 7516/2025), Ecuador AM 0075-2017, Honduras Acuerdo 041-2020, Panama Decretos 1843/2014 and 6/2015 — still appear in vendor decks.
    4. Assuming obligation implies pathway. Costa Rica and Ecuador show mandate without a clean post-trial import article. Mechanism has to be constructed; it is not “file compassionate use.”
    5. Inventing PTA where the map says none. Colombia and Mexico are the usual victims of template overreach.

    Operator checklist before you pick a petition name

    1. Classify the country: binding PTA / weak / none — using the current instrument on the operator map.
    2. Decide whether the patients are trial participants (cohort PTA) or named patients outside that dossier (exceptional / RAEM-style).
    3. Name the authorizing office and article you will put in the work order — not “the agency.”
    4. Confirm whether devices are textually in scope (Costa Rica Art. 53(k), Brazil Art. 37, Chile Art. 111 A, Peru Art. 2.1.36; Ecuador AM 00069-2024 is medicines-oriented).
    5. Appoint the importer of record for the period after the trial import permit lapses.
    6. Size cold chain and pharmacovigilance for the real duration — Brazil’s five-year clock starts at Brazilian commercial availability; Chile’s Art. 111 C has no commercialization endpoint.

    Working on a LATAM post-trial or exceptional-access program? bioaccess® is a US-headquartered, LATAM-native operator running regulatory, importadora, and 2–8 °C GDP cold-chain functions directly across the region. If you need the instrument, desk, and petition type mapped for a live protocol country list, contact Julio Martinez-Clark, Co-Founder & CEO, at jmclark@bioaccessla.com or +1 (954) 903-7210. More at bioaccessla.com/roadmap.

    Frequently asked questions

    Is compassionate use the same as post-trial access in Latin America?

    Usually no. Post-trial access is continued supply to participants of an authorized trial under a country-specific duty or ethics framework. Compassionate use / exceptional / RAEM-style routes are typically individual-patient pathways that may have nothing to do with a closed or closing trial dossier. Argentina’s Disp. 12792/2016 versus Disp. 4616/2019 is the clearest split; Brazil’s ANVISA assistance channel literally counts compassionate use, expanded access, and post-study supply as separate request types.

    Can I use Argentina’s RAEM for my trial cohort?

    No. RAEM under Disposición 4616/2019 is an individual-patient exceptional import regime with no clinical-trial reference, patient-as-filer rules, and short quantity/validity windows. Cohort post-trial access runs on Disposición 12792/2016, filed by the sponsor before study end.

    Does Brazil treat post-study supply as compassionate use?

    No. Lei 14.874/2024 and Decreto 12.651/2025 create a sponsor PTA duty with a pre-trial CEP plan. RDC 38/2013 lists post-study supply alongside compassionate use and expanded access as assistance programs, but they are different request types. Ministry language calls post-study supply a legal duty, not an expectation.

    Which LATAM countries require post-trial access?

    Ten with binding statutory mandates: Argentina, Brazil, Chile, Peru, Ecuador, Costa Rica, Guatemala, Honduras, Nicaragua and Panama. Three with weak or unassigned duties: Uruguay, Bolivia, Venezuela. Seven with none, including Colombia and Mexico. Read the current instrument — five countries changed frameworks between 2024 and 2026.

    Does Costa Rica’s Ley 9234 cover devices for PTA?

    Yes. Art. 53(k) expressly includes dispositivo alongside medicamento and procedimiento. Duration is “mientras lo requieran” under Art. 28. That is PTA, not a U.S. expanded-access petition — and the statute still does not hand you a dedicated post-trial import article.

    Does Colombia require compassionate use or PTA after a device trial?

    Colombia does not currently mandate post-trial access by statute. Voluntary continuity can still be arranged through the ethics committee, informed consent and general import rules. Do not file a U.S.-style expanded-access template as if INVIMA had a PTA desk for closed studies.

    How should a sponsor pick between PTA and named-patient filings?

    Start from patient status and country instrument. Trial participants in a mandate country → country PTA filing (Argentina 12792, Brazil CEP/ANVISA post-estudo, Panama Art. 68 extension, and so on). Individual patients outside that cohort → the country’s exceptional / compassionate / RAEM-style path, if one exists. Then confirm importer of record, cold chain and PV clocks. Use the ten diligence questions on the PTA operator evaluation page before you sign a work order.

  • How to evaluate a LATAM post-trial access operator: 10 questions to ask

    Most “who does post-trial access in Latin America” shortlists are vendor decks. The diligence question is whether the operator can still import, cold-chain, report safety, and keep patients on product years after database lock — under the instrument that is actually in force in that country.

    I am Julio Martinez-Clark, CEO of bioaccess®. Use these ten questions before you sign a PTA work order. They map to our published LATAM post-trial access operator map and legal architecture pillars. This is not a quote and not legal advice.

    Regulatory questions

    1. Which current instrument and article create the duty? Ask for the citation they will put in the work order: Panama Decreto Ejecutivo 21/2026 Art. 68, Brazil Lei 14.874/2024 Arts. 30–37 and Decreto 12.651/2025, Chile Código Sanitario Art. 111 C (Ley 20.850), Argentina ANMAT Disposición 12792/2016, Peru DS 021-2017-SA Arts. 115–118, Costa Rica Ley 9234 Art. 53(k). If the proposal still cites a repealed Panama Decreto 27/2024 path or treats Argentina Disposición 6677/2010 as if Disp. 7516/2025 erased 12792, stop.
    2. Which office authorizes the continued-supply file? Name the authorizing desk — not “the agency.” Argentina’s post-study import is a Disposición 12792 filing before study end; Brazil’s CEP/ANVISA stack and RDC 38/2013 framing are not interchangeable with Argentina’s cohort route. Wrong office is a multi-month miss.
    3. Does the country mandate PTA for devices at all? Our operator map is explicit: Colombia does not currently mandate post-trial access by statute. Ecuador stays off the “express device mandate” column unless a primary instrument says otherwise. Do not buy a Colombia PTA program that invents a duty the map does not list.

    Import and supply questions

    1. Who is importer of record after the trial import permit lapses? PTA fails when the trial-only import story dies at LPLV. Ask who holds the extension, special-import, or successor authorization, and whether that role is the same entity named as registration holder later.
    2. Can they keep 2–8 °C (or the protocol’s real band) for years past database lock? Multi-year cohort supply is a GDP problem, not a courier problem. Ask for the named depot, excursion SOP, and who owns product that is still on patients after the CRO’s “study close” invoice.
    3. What are the pharmacovigilance onward-transmission clocks? PTA is still a safety file. Ask who receives SAEs from sites, who files to the national authority, and who keeps the SDEA alive when the original CRO work order ends.

    Contract and liability questions

    1. Is there a signed SDEA within a defined window? Our legal-architecture pillar treats ICH E2A/E2F-style safety exchange as part of the PTA stack, not an afterthought. “We will paper PV later” is a red flag.
    2. Which country DPA model is on the table? Argentina Ley 25.326 / AAIP tooling, Brazil LGPD, Chile Ley 21.719 (in force 1 December 2026), Peru DS 016-2024-JUS, and Mexico’s LFPDPPP stack are not one regional template. Ask for the controller/processor labels in local terms.
    3. Is sponsor accession a condition of signature? Product-liability and patient-continuity risk should not sit only on a local operator while the US sponsor stays off the accession page. If the work order is silent, assume the gap is intentional.
    4. What is the patient-continuity run-off if the operator exits? Ask for the written handoff: who imports next, who holds temperature-controlled stock, who tells the investigator and the patient, and which instrument keeps the file open. A PTA proposal without a run-off clause is a brochure.

    Red flags in proposals

    • Reliance on repealed or misnamed instruments (wrong Panama decreto; “Ley 419/2023” folklore; Argentina RAEM sold as the trial-cohort PTA route).
    • Mixing commercial registro / IOR sales with PTA duty as if they were the same file.
    • No named authorizing office, no cold-chain owner, no PV clock, no DPA country, no accession language.
    • A single “LATAM PTA” price that pretends Brazil Art. 37, Chile Art. 111 C, and Panama Art. 68 are one operating system.

    What “operator” has to mean for multi-year PTA

    A LATAM PTA operator is not a one-time importer who can forward a carton. The map pillar’s job is country×instrument clarity; the operator’s job is to keep that instrument executable after the CRO’s study budget ends. That usually means one accountable party for continued import authorization, GDP storage, PV exchange, and patient-facing continuity — not a chain of layered subcontracts that each expire at database lock.

    Compare that to commercial market access. The LATAM registration holder / IOR line and bioaccess® market access answer who holds registro for already FDA-cleared or CE-marked devices. PTA answers who keeps beneficial investigational (or successor) supply moving under a trial-era duty. Mixing the two in one proposal is how diligence fails.

    How to use the answers

    Score each question pass/fail against the country you actually need. Then open the country pillar: Panama Decreto 21/2026 Art. 68, Brazil Lei 14.874, Argentina Disp. 12792/2016, Chile Ley 20.850 / Art. 111 C, Peru DS 021-2017-SA. Market-access registro questions stay on LATAM market access — they do not replace the PTA diligence file.

    If you want bioaccess® to run the diligence against a live protocol country list, send the protocol stage, device risk class, and which countries already have patients on treatment. We will map the instrument, authorizing office, and contract gaps — without inventing a duty the statute does not create.

  • Does Chile’s post-trial access duty transfer to an M&A buyer?

    Yes. The second paragraph of Código Sanitario Article 111 C binds the sanitary-registration holder even when that party never held the provisional-use authorization and even when it acquired the registration afterwards. The free continued-supply duty travels with the Chilean registration by operation of law.

    I am Julio Martinez-Clark, CEO of bioaccess®. This page is the M&A diligence cut. For the full Art. 111 C analysis, device scope, and ISP role, use Post-trial access in Chile under Ley 20.850 and Código Sanitario Art. 111 C. For the 1 December 2026 DPA refresh under Ley 21.719, use Chile Ley 21.719 PTA DPA refresh.

    Short answer

    Article 111 C, first paragraph, gives the trial patient a right to free continuity of treatment after the study ends, for as long as therapeutic usefulness persists, from (1) the holder of the special provisional-use authorization and, later, (2) the holder of the sanitary registration. The second paragraph is the deal clause:

    “Esta obligación afectará al titular del registro sanitario, aun cuando no haya sido el titular de la autorización provisional o haya adquirido con posterioridad el registro sanitario.”

    Read that literally. An asset purchase that transfers only the Chilean registration — no trial contracts, no site agreements, no sponsor entity — still carries the tail. A licensing deal in which the licensee becomes the Chilean registration holder does the same. Standard reps and warranties rarely surface it, and standard product P&Ls never price it.

    Diligence questions before you buy or in-license

    1. Was any Chilean trial run under an ISP provisional-use authorization for this product, per the public research register ISP must keep under Article 111 A?
    2. How many participants remain on treatment, under what protocol definition of continued benefit?
    3. Who has supplied them since study close, under what import authorization?
    4. Do the indemnities in the purchase agreement acknowledge that the statutory duty to the patient sits with whoever holds the registration — not only with the seller’s representations?

    Breach of Title V is sanctioned under Article 111 G, which routes infractions to Book Ten of the Código Sanitario and to Ley 20.120. Book Ten’s general penalty article allows fines from one-tenth of a UTM up to 1,000 UTM, doubled on recidivism, plus suspension of distribution and use of the products concerned (Código Sanitario Art. 174).

    Devices and open-ended duration

    Devices are expressly in scope through Article 111 A’s “elementos de uso médico,” so the Art. 111 C duty is not a drug-only problem. Duration has no calendar end point: termination turns on loss of therapeutic usefulness under the study protocol, not commercial launch and not a fixed number of years. Brazil’s Lei 14.874/2024 Art. 33 VI permits interruption five years after commercial availability; Chile has a named obligor and no clock.

    Keep the Art. 111 C supply analysis separate from the data-protection contract. Ley 21.719 enters into force on 1 December 2026 and changes how Chilean PTA DPAs should be drafted — that is a companion workstream, not a substitute for the supply diligence above.

    bioaccess® operates regulatory, importadora and PTA architecture for Latin American post-trial programs. For Chile PTA diligence on a live asset or in-license, contact Julio Martinez-Clark, Co-Founder & CEO, at jmclark@bioaccessla.com or +1 (954) 903-7210. More at bioaccessla.com/roadmap.

    Related pillar

    Post-trial access in Chile under Ley 20.850 and Código Sanitario Art. 111 C

    Sources

    • Ley Núm. 20.850, Ministerio de Salud, promulgated 1 June 2015 — https://www.bcn.cl/leychile/navegar?idNorma=1078148
    • Código Sanitario (DFL 725), Article 111 C — https://www.bcn.cl/leychile/navegar?idNorma=5595
    • Chile PTA pillar: https://bioaccessla.com/blog/chile-post-trial-access-ley-20850
    • Chile Ley 21.719 DPA refresh: https://bioaccessla.com/blog/chile-ley-21719-pta-dpa-refresh