ISP/ANDIM rules and guidance for medical device market access, registration, and lifecycle compliance. Each code opens a metadata page with the official source and readable HTML when available.
| Code | Regulation | Category | Effective | Provenance |
|---|---|---|---|---|
| ANDID/009 | ANDID/009 — controlled IVD registration-change instructions linked by ISP Complete six-page source linked by ISP as the DMDIV instruction for service9100017. The printed heading says FORMULARIO ANDID/009, version0, emission/update02/03/2023; its explanatory field instructions and IVD-specific responsible-professional wording are preserved. Legal manufacturer, manufacturing plant, legal representative, sanitary-registration holder and the distinct source change choices remain separate. No extension to every IVD or current2026 legal applicability is inferred. Source-only preservation; no facts, fee values, timing, bindings or question-completion status changes. | Registration | — | Official |
| 9100017 | Modificación de registro de dispositivos médicos bajo control sanitario Complete three-page ISP service sheet, version3, updated02/01/2026, for changes to existing sanitary registrations of controlled medical devices, including IVD. Device and IVD supporting-document branches, legal-holder transfer, legal-manufacturer authorization and source conditions are retained. It does not establish that all devices require mandatory sanitary registration. Source-only preservation; no facts, fee values, timing, bindings or question-completion status changes. | Registration | — | Official |
| Decreto 25 Exento (2026) | Specified medical devices and IVDs under sanitary control — complete signed DE 25 gazette component CVE 2781436 Complete eight-page electronically signed Diario Oficial component CVE 2781436, hosted by ISP, for Decreto 25 Exento dated 6 March 2026 and published 19 March 2026 in issue 44.404. It is the complete component, not the whole gazette issue. Preserves the specified medical-device and IVD product tables, applicable standards, Article 6 change provisions, and product-dependent 24/36-month transitional schedules and further-implementing-instruction conditions. Article 6 contains a visibly incomplete source sentence around “en su mérito y”; the original wording and pixels are preserved without repair or inferred missing words. Current applicability and completion of implementing measures remain unverified. Historical successful curl/browser-agent provenance is retained separately from failed alternative routes; no fresh GET is claimed. Complete original page images govern qualified native search text. No new legal facts or question completion. | Registration | — | Official |
| 9200004 | Modificación de antecedentes que acompañan a los dispositivos médicos y dispositivos médicos de diagnóstico in vitro Complete five-page ISP service sheet, version03, updated02/01/2026. It concerns modification of a certificate of review of antecedents or verification of conformity, including separate medical-device and IVD document branches. Full original requirements, conditional handling/validity wording and page context remain visible; it is not a universal sanitary-registration requirement or a substituted company/warehouse licence. Source-only preservation; no facts, fee values, timing, bindings or question-completion status changes. | Registration | — | Official |
| Decreto Supremo 825 (1998) | Control of medical-use products and elements — complete DS 825 BCN expression of 21 August 1999 Complete nine-page official BCN generated expression of Decreto 825, Ministry of Health: promulgated 30 November 1998, published 21 August 1999, and labelled Versión Única de 21-AGO-1999. Article 2 expressly includes in-vitro diagnostic devices; Article 22 makes compulsory conformity control progressive through product-specific decrees rather than proving that every device already requires registration. The official compilation and its generation footer are retained, with no inference that it incorporates all later legal changes. Historical normal-browser download completion is evidenced; its HTTP status and numeric TLS result were not recorded and remain unknown. Original page images govern the qualified native search text. No currentness, question-completeness or new legal-fact conclusion. | Registration | — | Official |
| ISP E1199/2026 — BCN expression after E1729 | Resolución exenta E1199/2026 — complete official BCN expression incorporating E1729 Complete31-page official BCN generated expression, displaying promulgation26February2026, publication7May2026 and E1729 amendment. Embedded tariff page graphics and BCN notes are retained as original images; some table content is absent from native text. Distinct from the33-page agency signed expression; no byte, page or whole-expression identity is inferred. Mixed-sector schedule does not make unrelated rows device requirements. | General | — | Official |
| ISP E1199/2026 — signed agency expression | Resolución exenta E1199/2026 — complete signed ISP tariff original Complete33-page signed ISP tariff expression. General rules, full tariff and electronic-signature close are retained. Medical-device service rows are a limited part of the mixed-sector schedule; other laboratory, medicines, food and institutional rows remain context, not device obligations. Original commencement wording is retained as historical text; separately held E1729 corrects resuelvo3. No present fee/current-law determination or question verification. | General | — | Official |
| ISP E1729/2026 — BCN expression | Resolución exenta E1729/2026 — official BCN commencement correction expression Complete two-page official BCN generated expression. It states publication7May2026 and promulgation27March2026, replaces E1199 resuelvo3 with10April2026 commencement and leaves the other provisions unchanged. This is an official generated legal expression, not a signed Gazette scan. No independent present-day fee or legal-currentness opinion. | General | — | Official |
| ISP 9200004 — IVD administrative antecedents | ANDIM/029 — IVD administrative antecedent change instructions Complete ten-page ISP/ANDIM instructions for IVD administrative antecedent changes, version 1, emitted June2,2023 and updated March19,2026. OEM/OBL/ODM, legal manufacturer, manufacturing plants, certificate holder and legal representative remain distinct; supporting-document conditions are retained. | Registration | — | Official |
| ANDIM/029 | Instructivo ANDIM/029 — modificación y/o actualización de antecedentes técnicos de DMDIV Complete22-page ISP technical IVD-change instructions, version1, emission01/06/2023 and update19/03/2026. All original technical-characteristic, brand/name/model, legal-manufacturer, manufacturing-plant and responsible-party definitions and supporting-document conditions are retained. This is a distinct technical instruction from the already preserved10-page administrative instruction and10-page technical/legal change guidance; no blanket equivalence between commercialREF and approved model or current-law conclusion is inferred. Source-only preservation; no facts, fee values, timing, bindings or question-completion status changes. | Registration | — | Official |
| ISP — DMDIV technical and legal antecedents | Modification and updating of IVD administrative and technical antecedents Complete ten-page ISP guidance on reportable, substantial, non-substantial and non-reportable IVD changes. Certificate and sanitary-registration branches, change-specific conditions and authority review are preserved. The source is undated; citation access dates do not establish its publication date. | Registration | — | Official |
Exports carry source + retrieval dateSource-linked rules for common changes to a registered IVD. Read the scope and conditions with each rule; unverified details are listed separately.
A change to the registered brand name and a change to logo artwork can follow different rules. The legal manufacturer, device design and intended purpose remain the same.
Verified guidance on
Read each rule with its scope and conditions.
DS825 Art. 22 applies compulsory conformity control progressively through product-specific decrees. Being an MD or IVD does not by itself prove that the product already has a sanitary registration. Identify the actual ISP registration, conformity certificate or antecedent-review certificate before selecting a change service.
DE 47/2025 for its listed sterile single-use needles/syringes is in the current10October2026 expression and requires later relevant modifications to be notified, with possible renewed assessment. DE 25/2026 has product-specific24/36-month deferred implementation from its 19March2026 publication, with the stated conditional voluntary early route; DE 31/2026 blood-donation serology has12-month deferred implementation from 24March2026 and its own exclusions. Do not treat these future groups as if every device/IVD were already registered in October 2026.
ISP’s IVD guidance IVc.2 lists trade name, product code, legal-manufacturer corporate name/commercial address, plant corporate name, representative/holder particulars and holder transfer as reportable administrative changes. A legal-manufacturer name/commercial-address change without a plant-address change is administrative. Provide a sworn no-impact declaration, reasons and updated labels/IFU. A logo-only exemption is not expressly stated by this list.
For an IVD conformity or antecedent-review certificate, use service 9200004; for an issued sanitary registration, use9100017. The holder submits the appropriate form, a Spanish technical-notification report explaining the changes, supporting documents and a comparative table. ISP may require further assessment, new conformity verification or a new registration according to the change’s impact.
E1199’s2026 schedule sets9200004 certificate/antecedent modification and9100017 sanitary-registration modification at CLP69,321 net each. Company-enrollment modification9200003 is separately CLP69,321; warehouse corporate-name modification9200008 is CLP184,850. Applicable tax is additional. E1729 states commencement10April2026; a multi-change or multi-registration total is not established by the single service row.
The 9100017 technical sheet, version3 updated2January2026, publishes45 working days on average only if no new supporting information is required. Evaluation follows payment and may generate observations for correction. This is a service average, not a guaranteed statutory decision date or a period to add to another service automatically.
The 9200004 technical sheet publishes45 working days on average only if new supporting information is not required. Its certificate validity is a separate period, not review time. Do not substitute conformity-provider authorization clocks or a registration’s validity for this modification estimate.
ISP service 9200010 is an application for exceptional device-stock exhaustion with documents supporting and justifying the request, submitted through the SAFIS electronic form. Its published average is30 working days if no additional information is needed; an issued authorization is valid six months from its resolution. Neither period is an automatic stock grace for a name, brand or entity change. The 2026 fee schedule lists this service at CLP80,872 net plus applicable tax.
The service sheet retains a pharmaceutical/donation template phrase in workflow step13; it is not adopted as a device eligibility condition.
For9200004, the administrative-IVD instructivo requires a Spanish change report with comparison, justification and signatures, plus a sworn statement that no other changes are made. Provide highlighted primary/secondary labels and Spanish IFU, or signed unchanged documents; imported-product English and Spanish IFUs must correspond to the same current version.
The registered-IVD instructivo requires competent-authority corporate-name proof, constitution and amendments where applicable, a notarized holder-transfer agreement and explicit legal-manufacturer authorization for the requested modification. Submit only the change-specific documents, with foreign documents legalized/apostilled as stated. Manufacturer, holder and factory addresses are separate fields.
Registered-IVD instructivo§6 allows selection of more than one modification but expressly says the tariff must be paid for each. The comparable MD instructivo allows multiple selections without that same sentence; do not silently extend the IVD charging statement to every MD or certificate service.
For9200004 certificate modifications involving product name, models/codes or legal manufacturer, the current free-sale/export certificate must reflect the changed details. Imported certificates are legalized/apostilled. An export-only certificate saying the product is not authorized/marketed in its issuing country is insufficient without another official free-sale proof. The instructivo also requires current legal-manufacturer and applicable OEM/OBL/ODM/plant QMS evidence with at least six months remaining at filing, including assembly sites where applicable.
The same legal manufacturer changes its name, potentially alongside the device brand. A transfer to another legal entity is a separate question; permission to combine filings needs its own evidence.
Verified guidance on
Read each rule with its scope and conditions.
DS825 Art. 22 applies compulsory conformity control progressively through product-specific decrees. Being an MD or IVD does not by itself prove that the product already has a sanitary registration. Identify the actual ISP registration, conformity certificate or antecedent-review certificate before selecting a change service.
DE 47/2025 for its listed sterile single-use needles/syringes is in the current10October2026 expression and requires later relevant modifications to be notified, with possible renewed assessment. DE 25/2026 has product-specific24/36-month deferred implementation from its 19March2026 publication, with the stated conditional voluntary early route; DE 31/2026 blood-donation serology has12-month deferred implementation from 24March2026 and its own exclusions. Do not treat these future groups as if every device/IVD were already registered in October 2026.
ISP’s IVD guidance IVc.2 lists trade name, product code, legal-manufacturer corporate name/commercial address, plant corporate name, representative/holder particulars and holder transfer as reportable administrative changes. A legal-manufacturer name/commercial-address change without a plant-address change is administrative. Provide a sworn no-impact declaration, reasons and updated labels/IFU. A logo-only exemption is not expressly stated by this list.
For an IVD conformity or antecedent-review certificate, use service 9200004; for an issued sanitary registration, use9100017. The holder submits the appropriate form, a Spanish technical-notification report explaining the changes, supporting documents and a comparative table. ISP may require further assessment, new conformity verification or a new registration according to the change’s impact.
E1199’s2026 schedule sets9200004 certificate/antecedent modification and9100017 sanitary-registration modification at CLP69,321 net each. Company-enrollment modification9200003 is separately CLP69,321; warehouse corporate-name modification9200008 is CLP184,850. Applicable tax is additional. E1729 states commencement10April2026; a multi-change or multi-registration total is not established by the single service row.
The 9100017 technical sheet, version3 updated2January2026, publishes45 working days on average only if no new supporting information is required. Evaluation follows payment and may generate observations for correction. This is a service average, not a guaranteed statutory decision date or a period to add to another service automatically.
The 9200004 technical sheet publishes45 working days on average only if new supporting information is not required. Its certificate validity is a separate period, not review time. Do not substitute conformity-provider authorization clocks or a registration’s validity for this modification estimate.
ISP service 9200010 is an application for exceptional device-stock exhaustion with documents supporting and justifying the request, submitted through the SAFIS electronic form. Its published average is30 working days if no additional information is needed; an issued authorization is valid six months from its resolution. Neither period is an automatic stock grace for a name, brand or entity change. The 2026 fee schedule lists this service at CLP80,872 net plus applicable tax.
The service sheet retains a pharmaceutical/donation template phrase in workflow step13; it is not adopted as a device eligibility condition.
For9200004, the administrative-IVD instructivo requires a Spanish change report with comparison, justification and signatures, plus a sworn statement that no other changes are made. Provide highlighted primary/secondary labels and Spanish IFU, or signed unchanged documents; imported-product English and Spanish IFUs must correspond to the same current version.
The registered-IVD instructivo requires competent-authority corporate-name proof, constitution and amendments where applicable, a notarized holder-transfer agreement and explicit legal-manufacturer authorization for the requested modification. Submit only the change-specific documents, with foreign documents legalized/apostilled as stated. Manufacturer, holder and factory addresses are separate fields.
Registered-IVD instructivo§6 allows selection of more than one modification but expressly says the tariff must be paid for each. The comparable MD instructivo allows multiple selections without that same sentence; do not silently extend the IVD charging statement to every MD or certificate service.
For9200004 certificate modifications involving product name, models/codes or legal manufacturer, the current free-sale/export certificate must reflect the changed details. Imported certificates are legalized/apostilled. An export-only certificate saying the product is not authorized/marketed in its issuing country is insufficient without another official free-sale proof. The instructivo also requires current legal-manufacturer and applicable OEM/OBL/ODM/plant QMS evidence with at least six months remaining at filing, including assembly sites where applicable.
An office address change for the same legal entity, potentially alongside name and brand changes. This does not cover moving a factory or manufacturing site, and a combined filing cannot be assumed.
Verified guidance on
Read each rule with its scope and conditions.
DS825 Art. 22 applies compulsory conformity control progressively through product-specific decrees. Being an MD or IVD does not by itself prove that the product already has a sanitary registration. Identify the actual ISP registration, conformity certificate or antecedent-review certificate before selecting a change service.
DE 47/2025 for its listed sterile single-use needles/syringes is in the current10October2026 expression and requires later relevant modifications to be notified, with possible renewed assessment. DE 25/2026 has product-specific24/36-month deferred implementation from its 19March2026 publication, with the stated conditional voluntary early route; DE 31/2026 blood-donation serology has12-month deferred implementation from 24March2026 and its own exclusions. Do not treat these future groups as if every device/IVD were already registered in October 2026.
ISP’s IVD guidance IVc.2 lists trade name, product code, legal-manufacturer corporate name/commercial address, plant corporate name, representative/holder particulars and holder transfer as reportable administrative changes. A legal-manufacturer name/commercial-address change without a plant-address change is administrative. Provide a sworn no-impact declaration, reasons and updated labels/IFU. A logo-only exemption is not expressly stated by this list.
For an IVD conformity or antecedent-review certificate, use service 9200004; for an issued sanitary registration, use9100017. The holder submits the appropriate form, a Spanish technical-notification report explaining the changes, supporting documents and a comparative table. ISP may require further assessment, new conformity verification or a new registration according to the change’s impact.
E1199’s2026 schedule sets9200004 certificate/antecedent modification and9100017 sanitary-registration modification at CLP69,321 net each. Company-enrollment modification9200003 is separately CLP69,321; warehouse corporate-name modification9200008 is CLP184,850. Applicable tax is additional. E1729 states commencement10April2026; a multi-change or multi-registration total is not established by the single service row.
The 9100017 technical sheet, version3 updated2January2026, publishes45 working days on average only if no new supporting information is required. Evaluation follows payment and may generate observations for correction. This is a service average, not a guaranteed statutory decision date or a period to add to another service automatically.
The 9200004 technical sheet publishes45 working days on average only if new supporting information is not required. Its certificate validity is a separate period, not review time. Do not substitute conformity-provider authorization clocks or a registration’s validity for this modification estimate.
ISP service 9200010 is an application for exceptional device-stock exhaustion with documents supporting and justifying the request, submitted through the SAFIS electronic form. Its published average is30 working days if no additional information is needed; an issued authorization is valid six months from its resolution. Neither period is an automatic stock grace for a name, brand or entity change. The 2026 fee schedule lists this service at CLP80,872 net plus applicable tax.
The service sheet retains a pharmaceutical/donation template phrase in workflow step13; it is not adopted as a device eligibility condition.
For9200004, the administrative-IVD instructivo requires a Spanish change report with comparison, justification and signatures, plus a sworn statement that no other changes are made. Provide highlighted primary/secondary labels and Spanish IFU, or signed unchanged documents; imported-product English and Spanish IFUs must correspond to the same current version.
The registered-IVD instructivo requires competent-authority corporate-name proof, constitution and amendments where applicable, a notarized holder-transfer agreement and explicit legal-manufacturer authorization for the requested modification. Submit only the change-specific documents, with foreign documents legalized/apostilled as stated. Manufacturer, holder and factory addresses are separate fields.
Registered-IVD instructivo§6 allows selection of more than one modification but expressly says the tariff must be paid for each. The comparable MD instructivo allows multiple selections without that same sentence; do not silently extend the IVD charging statement to every MD or certificate service.
For9200004 certificate modifications involving product name, models/codes or legal manufacturer, the current free-sale/export certificate must reflect the changed details. Imported certificates are legalized/apostilled. An export-only certificate saying the product is not authorized/marketed in its issuing country is insufficient without another official free-sale proof. The instructivo also requires current legal-manufacturer and applicable OEM/OBL/ODM/plant QMS evidence with at least six months remaining at filing, including assembly sites where applicable.
Check which identifier actually changes. A commercial catalogue, REF or order code is not automatically a device model, registered identifier, GTIN or UDI-DI. Rules for one identifier do not establish the route for another.
Verified guidance on
Read each rule with its scope and conditions.
DS825 Art. 22 applies compulsory conformity control progressively through product-specific decrees. Being an MD or IVD does not by itself prove that the product already has a sanitary registration. Identify the actual ISP registration, conformity certificate or antecedent-review certificate before selecting a change service.
DE 47/2025 for its listed sterile single-use needles/syringes is in the current10October2026 expression and requires later relevant modifications to be notified, with possible renewed assessment. DE 25/2026 has product-specific24/36-month deferred implementation from its 19March2026 publication, with the stated conditional voluntary early route; DE 31/2026 blood-donation serology has12-month deferred implementation from 24March2026 and its own exclusions. Do not treat these future groups as if every device/IVD were already registered in October 2026.
ISP’s IVD guidance IVc.2 lists trade name, product code, legal-manufacturer corporate name/commercial address, plant corporate name, representative/holder particulars and holder transfer as reportable administrative changes. A legal-manufacturer name/commercial-address change without a plant-address change is administrative. Provide a sworn no-impact declaration, reasons and updated labels/IFU. A logo-only exemption is not expressly stated by this list.
For an IVD conformity or antecedent-review certificate, use service 9200004; for an issued sanitary registration, use9100017. The holder submits the appropriate form, a Spanish technical-notification report explaining the changes, supporting documents and a comparative table. ISP may require further assessment, new conformity verification or a new registration according to the change’s impact.
E1199’s2026 schedule sets9200004 certificate/antecedent modification and9100017 sanitary-registration modification at CLP69,321 net each. Company-enrollment modification9200003 is separately CLP69,321; warehouse corporate-name modification9200008 is CLP184,850. Applicable tax is additional. E1729 states commencement10April2026; a multi-change or multi-registration total is not established by the single service row.
The 9100017 technical sheet, version3 updated2January2026, publishes45 working days on average only if no new supporting information is required. Evaluation follows payment and may generate observations for correction. This is a service average, not a guaranteed statutory decision date or a period to add to another service automatically.
The 9200004 technical sheet publishes45 working days on average only if new supporting information is not required. Its certificate validity is a separate period, not review time. Do not substitute conformity-provider authorization clocks or a registration’s validity for this modification estimate.
ISP service 9200010 is an application for exceptional device-stock exhaustion with documents supporting and justifying the request, submitted through the SAFIS electronic form. Its published average is30 working days if no additional information is needed; an issued authorization is valid six months from its resolution. Neither period is an automatic stock grace for a name, brand or entity change. The 2026 fee schedule lists this service at CLP80,872 net plus applicable tax.
The service sheet retains a pharmaceutical/donation template phrase in workflow step13; it is not adopted as a device eligibility condition.
For9200004, the administrative-IVD instructivo requires a Spanish change report with comparison, justification and signatures, plus a sworn statement that no other changes are made. Provide highlighted primary/secondary labels and Spanish IFU, or signed unchanged documents; imported-product English and Spanish IFUs must correspond to the same current version.
The registered-IVD instructivo requires competent-authority corporate-name proof, constitution and amendments where applicable, a notarized holder-transfer agreement and explicit legal-manufacturer authorization for the requested modification. Submit only the change-specific documents, with foreign documents legalized/apostilled as stated. Manufacturer, holder and factory addresses are separate fields.
Registered-IVD instructivo§6 allows selection of more than one modification but expressly says the tariff must be paid for each. The comparable MD instructivo allows multiple selections without that same sentence; do not silently extend the IVD charging statement to every MD or certificate service.
For9200004 certificate modifications involving product name, models/codes or legal manufacturer, the current free-sale/export certificate must reflect the changed details. Imported certificates are legalized/apostilled. An export-only certificate saying the product is not authorized/marketed in its issuing country is insufficient without another official free-sale proof. The instructivo also requires current legal-manufacturer and applicable OEM/OBL/ODM/plant QMS evidence with at least six months remaining at filing, including assembly sites where applicable.
A real change of legal manufacturer, registration holder or owner. This differs from renaming the same entity; a change of local representative or importer alone does not establish a registration transfer route. Where other changes occur with the transfer, the exact combination and sequence need separate evidence.
Verified guidance on
Read each rule with its scope and conditions.
DS825 Art. 22 applies compulsory conformity control progressively through product-specific decrees. Being an MD or IVD does not by itself prove that the product already has a sanitary registration. Identify the actual ISP registration, conformity certificate or antecedent-review certificate before selecting a change service.
DE 47/2025 for its listed sterile single-use needles/syringes is in the current10October2026 expression and requires later relevant modifications to be notified, with possible renewed assessment. DE 25/2026 has product-specific24/36-month deferred implementation from its 19March2026 publication, with the stated conditional voluntary early route; DE 31/2026 blood-donation serology has12-month deferred implementation from 24March2026 and its own exclusions. Do not treat these future groups as if every device/IVD were already registered in October 2026.
ISP’s IVD guidance IVc.2 lists trade name, product code, legal-manufacturer corporate name/commercial address, plant corporate name, representative/holder particulars and holder transfer as reportable administrative changes. A legal-manufacturer name/commercial-address change without a plant-address change is administrative. Provide a sworn no-impact declaration, reasons and updated labels/IFU. A logo-only exemption is not expressly stated by this list.
For an IVD conformity or antecedent-review certificate, use service 9200004; for an issued sanitary registration, use9100017. The holder submits the appropriate form, a Spanish technical-notification report explaining the changes, supporting documents and a comparative table. ISP may require further assessment, new conformity verification or a new registration according to the change’s impact.
E1199’s2026 schedule sets9200004 certificate/antecedent modification and9100017 sanitary-registration modification at CLP69,321 net each. Company-enrollment modification9200003 is separately CLP69,321; warehouse corporate-name modification9200008 is CLP184,850. Applicable tax is additional. E1729 states commencement10April2026; a multi-change or multi-registration total is not established by the single service row.
The 9100017 technical sheet, version3 updated2January2026, publishes45 working days on average only if no new supporting information is required. Evaluation follows payment and may generate observations for correction. This is a service average, not a guaranteed statutory decision date or a period to add to another service automatically.
The 9200004 technical sheet publishes45 working days on average only if new supporting information is not required. Its certificate validity is a separate period, not review time. Do not substitute conformity-provider authorization clocks or a registration’s validity for this modification estimate.
ISP service 9200010 is an application for exceptional device-stock exhaustion with documents supporting and justifying the request, submitted through the SAFIS electronic form. Its published average is30 working days if no additional information is needed; an issued authorization is valid six months from its resolution. Neither period is an automatic stock grace for a name, brand or entity change. The 2026 fee schedule lists this service at CLP80,872 net plus applicable tax.
The service sheet retains a pharmaceutical/donation template phrase in workflow step13; it is not adopted as a device eligibility condition.
For9200004, the administrative-IVD instructivo requires a Spanish change report with comparison, justification and signatures, plus a sworn statement that no other changes are made. Provide highlighted primary/secondary labels and Spanish IFU, or signed unchanged documents; imported-product English and Spanish IFUs must correspond to the same current version.
The registered-IVD instructivo requires competent-authority corporate-name proof, constitution and amendments where applicable, a notarized holder-transfer agreement and explicit legal-manufacturer authorization for the requested modification. Submit only the change-specific documents, with foreign documents legalized/apostilled as stated. Manufacturer, holder and factory addresses are separate fields.
For9200004 certificate modifications involving product name, models/codes or legal manufacturer, the current free-sale/export certificate must reflect the changed details. Imported certificates are legalized/apostilled. An export-only certificate saying the product is not authorized/marketed in its issuing country is insufficient without another official free-sale proof. The instructivo also requires current legal-manufacturer and applicable OEM/OBL/ODM/plant QMS evidence with at least six months remaining at filing, including assembly sites where applicable.
Registered-IVD instructivo§6 allows selection of more than one modification but expressly says the tariff must be paid for each. The comparable MD instructivo allows multiple selections without that same sentence; do not silently extend the IVD charging statement to every MD or certificate service.
Changes to brand, manufacturer name, office address and reference codes may occur together, including with a real transfer to another legal manufacturer, registration holder or owner. Assess transfer with each single change, and transfer with brand plus reference, manufacturer name plus reference, or office address plus reference changes: seven transfer combinations in total. Evidence must establish the exact combination and the order of filings and approvals. These combinations and their sequence are not all verified by the rules below; a rule for one change does not prove that a single application, fee or review period covers the combination.
Verified guidance on
Read each rule with its scope and conditions.
DS825 Art. 22 applies compulsory conformity control progressively through product-specific decrees. Being an MD or IVD does not by itself prove that the product already has a sanitary registration. Identify the actual ISP registration, conformity certificate or antecedent-review certificate before selecting a change service.
DE 47/2025 for its listed sterile single-use needles/syringes is in the current10October2026 expression and requires later relevant modifications to be notified, with possible renewed assessment. DE 25/2026 has product-specific24/36-month deferred implementation from its 19March2026 publication, with the stated conditional voluntary early route; DE 31/2026 blood-donation serology has12-month deferred implementation from 24March2026 and its own exclusions. Do not treat these future groups as if every device/IVD were already registered in October 2026.
ISP’s IVD guidance IVc.2 lists trade name, product code, legal-manufacturer corporate name/commercial address, plant corporate name, representative/holder particulars and holder transfer as reportable administrative changes. A legal-manufacturer name/commercial-address change without a plant-address change is administrative. Provide a sworn no-impact declaration, reasons and updated labels/IFU. A logo-only exemption is not expressly stated by this list.
For an IVD conformity or antecedent-review certificate, use service 9200004; for an issued sanitary registration, use9100017. The holder submits the appropriate form, a Spanish technical-notification report explaining the changes, supporting documents and a comparative table. ISP may require further assessment, new conformity verification or a new registration according to the change’s impact.
E1199’s2026 schedule sets9200004 certificate/antecedent modification and9100017 sanitary-registration modification at CLP69,321 net each. Company-enrollment modification9200003 is separately CLP69,321; warehouse corporate-name modification9200008 is CLP184,850. Applicable tax is additional. E1729 states commencement10April2026; a multi-change or multi-registration total is not established by the single service row.
The 9100017 technical sheet, version3 updated2January2026, publishes45 working days on average only if no new supporting information is required. Evaluation follows payment and may generate observations for correction. This is a service average, not a guaranteed statutory decision date or a period to add to another service automatically.
The 9200004 technical sheet publishes45 working days on average only if new supporting information is not required. Its certificate validity is a separate period, not review time. Do not substitute conformity-provider authorization clocks or a registration’s validity for this modification estimate.
ISP service 9200010 is an application for exceptional device-stock exhaustion with documents supporting and justifying the request, submitted through the SAFIS electronic form. Its published average is30 working days if no additional information is needed; an issued authorization is valid six months from its resolution. Neither period is an automatic stock grace for a name, brand or entity change. The 2026 fee schedule lists this service at CLP80,872 net plus applicable tax.
The service sheet retains a pharmaceutical/donation template phrase in workflow step13; it is not adopted as a device eligibility condition.
For9200004, the administrative-IVD instructivo requires a Spanish change report with comparison, justification and signatures, plus a sworn statement that no other changes are made. Provide highlighted primary/secondary labels and Spanish IFU, or signed unchanged documents; imported-product English and Spanish IFUs must correspond to the same current version.
The registered-IVD instructivo requires competent-authority corporate-name proof, constitution and amendments where applicable, a notarized holder-transfer agreement and explicit legal-manufacturer authorization for the requested modification. Submit only the change-specific documents, with foreign documents legalized/apostilled as stated. Manufacturer, holder and factory addresses are separate fields.
For9200004 certificate modifications involving product name, models/codes or legal manufacturer, the current free-sale/export certificate must reflect the changed details. Imported certificates are legalized/apostilled. An export-only certificate saying the product is not authorized/marketed in its issuing country is insufficient without another official free-sale proof. The instructivo also requires current legal-manufacturer and applicable OEM/OBL/ODM/plant QMS evidence with at least six months remaining at filing, including assembly sites where applicable.
Registered-IVD instructivo§6 allows selection of more than one modification but expressly says the tariff must be paid for each. The comparable MD instructivo allows multiple selections without that same sentence; do not silently extend the IVD charging statement to every MD or certificate service.
Each row above represents one regulatory instrument. Its code is the authority’s identifier. A regulation page collects the metadata and official source; when readable HTML is available, article links can open and highlight the exact cited passage.
Keep Chile as the target market while you move into registration records, classification, cross-country product research, or pathway planning.
Check a preliminary ISP/ANDIM risk class.
Search the same product in multiple country registries.
Estimate pathway, government fees, preparation, and review time.
Structure company, product, model, approval, and evidence facts once.
Compare existing evidence against Chile needs.
Connect route, evidence, labels, representatives, and launch dependencies.
Test a current ISP/ANDIM update against one product and its evidence.
