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Peru medical device regulations

Official sources linked

DIGEMID 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.

14 documents3 categories100% linked to official sourcesauthority DIGEMID14 readable HTML
CodeRegulationCategoryEffectiveProvenance
Formato de cambios de importancia menor — Versión1
Cambios de importancia menor de los dispositivos médicos y dispositivos médicos de diagnóstico in vitro — Versión1
Complete8-page official mandatory minor-change form and instructions. No printed issue date; do not infer a legal effective date.
Registration—Official
Instructivo de detalle — Abril2013
Registration model/code detail instructions — April2013 edition
Complete nine-page historical official instruction, still linked from the held26October2026 medical-device registration landing page. It explicitly distinguishes product reference/catalogue identification codes from device names and universal nomenclature, and describes their listing in the registration/re-registration detail table. The separate newer Version3 July2017 instruction exists and is preserved independently. The printed April2013 date is edition month only. Historical procedural media/TUPA details are not asserted current; no change-specific route or present commercial-REF/UDI conclusion is established. Source images govern; the embedded text is a qualified search layer. No whole-country completeness claim.
Registration—Official
Instructivo de formato complementario — Versión3 (Julio2017)
Registration detail form instructions — Version3, July2017
Complete eight-page official DIGEMID instruction linked from the held26October2026 company-forms page. Covers DMIMM-001, DMEB-002 and DMDIV-003 plus the common PartII table with distinct product code, model code/model, component and accessory fields. The printed July2017 date is edition month only. Registration/re-registration instructions do not by themselves establish a change-specific filing route, fees, deadlines or UDI outcome. Current consolidated legal applicability remains unverified. Source images govern; the embedded text is a qualified search layer. No whole-country completeness claim.
Registration—Official
DIGEMID medical-device FAQ
Preguntas Frecuentes — Disp. Médicos
Complete captured twenty-question medical-device FAQ tab and its actual tab title, including every original question, answer, paragraph, emphasis and the one original download link. Source-bound static presentation preserves all answer characters and order while making all captured answers visible. The source includes IVD-related answers, legacy decree references and statements phrased as current by the publisher; none is independently established here as a current 2026 requirement or exclusion. Non-device tabs, navigation and website shell are outside this expressly bounded source projection. No new fees, clocks, change classifications or answered-question determinations are inferred.
Registration—Official
D.S. 001-2012-SA
D.S. 001-2012-SA — amendments and transitional provisions
Complete four-page official DIGEMID-hosted gazette expression retained, including adjacent D.S. 002-2012-SA context on the final page. D.S. 001-2012-SA contains mixed pharmaceutical/medical-device amendments and an IVD transitional provision. Source preservation does not apply drug-only or neighboring-instrument provisions to MD/IVD. The original embedded text layer is visibly degraded; original page images govern. No new OCR or corrected wording is substituted. Present-day consolidated legal currentness remains unverified. Source images govern; the embedded text is a qualified search layer. No whole-country completeness claim.
Registration—Official
D.S. 014-2011-SA
Pharmaceutical Establishments Regulation — original D.S. 014-2011-SA scan
All 67 physical pages of the official DIGEMID-hosted 2011 scan retained, including the approving gazette page, regulation and two annexes. The approving gazette page includes adjacent unrelated norms as original layout context. The source covers establishments handling pharmaceuticals, medical devices and health products; source preservation does not extend drug-only provisions to MD/IVD. The 27 July 2011 gazette header is publication evidence. Decree Article 3 states commencement 180 calendar days after gazette publication; no absolute commencement date is calculated. No native text exists on any page; all original images govern, without OCR or invented text. The 2011 original is not established as a current consolidated expression.
GMP/QMS—Official
D.S. 016-2011-SA
Registration, Control and Sanitary Surveillance Regulation — original D.S. 016-2011-SA scan
All 140 physical pages of the official EsSalud-hosted 2011 scan retained, including the approving gazette page, regulation, tables and five annexes. The approving gazette page includes adjacent unrelated norms as original layout context. This complete source document mixes pharmaceuticals, medical devices and health products; preservation does not extend drug-only provisions to MD/IVD. The 27 July 2011 gazette header is publication evidence. Decree Article 2 states commencement 180 calendar days after gazette publication; no absolute commencement date is calculated. No native text exists on any page; all original images govern, without OCR or invented text. The 2011 original is not established as a current consolidated expression.
Registration—Official
D.S. 020-2001-SA
D.S. 020-2001-SA — amendments to the registration and surveillance regulation
Complete 15-page official government-hosted expression, including mixed pharmaceutical, medical-device and related-product amendments. Source preservation does not apply drug-only provisions to MD/IVD. Modified Articles 110–114 include clinical-diagnostic reagents and model/code registration-scope provisions; present-day applicability requires the later transitional and amendment chain. No current consolidated-law or unconditional commercial-REF outcome is asserted. Source images govern; the embedded text is a qualified search layer. No whole-country completeness claim.
Registration—Official
D.S. 011-2026-SA — TUPA
TUPA MINSA 2026 — approval decree and selected medical-device/IVD procedures
19 selected physical pages from the complete 377-page official TUPA PDF: the full three-page approving D.S. 011-2026-SA and eight complete two-page procedures for IVD inscription/reinscription, medical-device change, registration transfer, requested stock exhaustion, sanitary-registration certificate, free-sale certificate, and establishment-information changes. Full original PDF retained. All selected visible text and table cells were checked against page images; damaged PDF character encoding repaired in the fixed source-bound transcript. Printed anomalies are preserved. This is a selected source original, not a complete TUPA or consolidated current-law claim.
Registration—Official
Exports carry source + retrieval date

Changes after registration in Peru

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

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

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

Verified guidance on

Read each rule with its scope and conditions.

  • Filing route and prior approval

Eligible minor-change communication route

Fact-level verified

DIGEMID Version 1 defines eligible minor changes as having no significant effect on device safety/performance. The registration holder submits the enumerated change in writing to ANM; it proceeds automatically without a separate authority pronouncement. This route covers only the form’s enumerated cases and all their stated conditions; authorized establishment changes already operate in corresponding registrations without a further communication except case 1.5.

Conditions
  • The title expressly includes medical devices and in-vitro diagnostic medical devices.
  • No issue/effective date is printed on this Version 1 form. Do not substitute this narrow route for a substantive modification or transfer authorization.
  • Bounded reading of the cited official original; no claim that every question aspect or later amendment has been exhausted.

Passage context: pdf-page-1 — Opening rule and instructions. See the independently pinned evidence references for every supporting page.

Conditions for this question

  • Only eligible section 1.3 artwork changes without change to authorized information.
  • Filing route and prior approval
  • Labels and identifiers

Artwork-only label/IFU changes

Fact-level verified

Section 1.3 permits artwork/form changes without changing the information authorized under Articles 138 and 140 of DS 016-2011-SA as amended. Examples are color, size, font, foreign-authorization information, equivalent symbols and position, provided comprehension of the authorized information is preserved. This evidence does not classify a changed brand, legal manufacturer or model as merely cosmetic.

Conditions
  • Bounded reading of the cited official original; no claim that every question aspect or later amendment has been exhausted.

Passage context: pdf-page-3 — Section 1.3(1)-(2). See the independently pinned evidence references for every supporting page.

Conditions for this question

  • Only form/artwork changes meeting section 1.3; substantive approved-content changes require separate assessment.
  • Supporting documents

Minor communication form and evidence

Fact-level verified

The mandatory first sheet is a sworn declaration with applicant/device information. Select the applicable communication(s), meet every content-note condition, and give the date, full names and signatures of the legal representative and technical director. Append the applicable technical specifications/report, insert, immediate/outer labeling and other supporting material, and paginate the filing. General instructions file per sanitary registration; the foreign-address denomination sheet separately permits the qualifying same-manufacturer registrations to be listed.

Conditions
  • Supporting material depends on the selected eligible case; this is not an exhaustive substantive-change dossier.
  • Bounded reading of the cited official original; no claim that every question aspect or later amendment has been exhausted.

Passage context: pdf-page-1 — Mandatory instructions; section 1.4 sheet; also pdf-page-7. See the independently pinned evidence references for every supporting page.

Conditions for this question

  • Only when the particular event qualifies for the cited DIGEMID minor-change case; apply its separate case evidence.
Change control →Label, IFU & language →

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

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

Verified guidance on

Read each rule with its scope and conditions.

  • Filing route and prior approval

Eligible minor-change communication route

Fact-level verified

DIGEMID Version 1 defines eligible minor changes as having no significant effect on device safety/performance. The registration holder submits the enumerated change in writing to ANM; it proceeds automatically without a separate authority pronouncement. This route covers only the form’s enumerated cases and all their stated conditions; authorized establishment changes already operate in corresponding registrations without a further communication except case 1.5.

Conditions
  • The title expressly includes medical devices and in-vitro diagnostic medical devices.
  • No issue/effective date is printed on this Version 1 form. Do not substitute this narrow route for a substantive modification or transfer authorization.
  • Bounded reading of the cited official original; no claim that every question aspect or later amendment has been exhausted.

Passage context: pdf-page-1 — Opening rule and instructions. See the independently pinned evidence references for every supporting page.

Conditions for this question

  • Only section 1.5 domestic contract/staged laboratory company-name changes after the underlying authorization.
  • Filing route and prior approval
  • Supporting documents

Domestic contract/staged laboratory name

Fact-level verified

Section 1.5 applies a domestic laboratory company-name communication only in contract manufacturing or manufacturing by stages. The sheet requires the new company name and the number/date of the Resolución Directoral authorizing it, with file number/date. It does not establish a general automatic route for a foreign legal-manufacturer name change.

Conditions
  • Bounded reading of the cited official original; no claim that every question aspect or later amendment has been exhausted.

Passage context: pdf-page-3 — Section 1.5 and prior authorization field; also pdf-page-8. See the independently pinned evidence references for every supporting page.

Conditions for this question

  • Domestic laboratory in contract or staged manufacturing, with the underlying name authorization.
  • Supporting documents

Minor communication form and evidence

Fact-level verified

The mandatory first sheet is a sworn declaration with applicant/device information. Select the applicable communication(s), meet every content-note condition, and give the date, full names and signatures of the legal representative and technical director. Append the applicable technical specifications/report, insert, immediate/outer labeling and other supporting material, and paginate the filing. General instructions file per sanitary registration; the foreign-address denomination sheet separately permits the qualifying same-manufacturer registrations to be listed.

Conditions
  • Supporting material depends on the selected eligible case; this is not an exhaustive substantive-change dossier.
  • Bounded reading of the cited official original; no claim that every question aspect or later amendment has been exhausted.

Passage context: pdf-page-1 — Mandatory instructions; section 1.4 sheet; also pdf-page-7. See the independently pinned evidence references for every supporting page.

Conditions for this question

  • Only when the particular event qualifies for the cited DIGEMID minor-change case; apply its separate case evidence.
Change control →Label, IFU & language →

What changes when the manufacturer's office address changes?

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

Verified guidance on

Read each rule with its scope and conditions.

  • Filing route and prior approval

Eligible minor-change communication route

Fact-level verified

DIGEMID Version 1 defines eligible minor changes as having no significant effect on device safety/performance. The registration holder submits the enumerated change in writing to ANM; it proceeds automatically without a separate authority pronouncement. This route covers only the form’s enumerated cases and all their stated conditions; authorized establishment changes already operate in corresponding registrations without a further communication except case 1.5.

Conditions
  • The title expressly includes medical devices and in-vitro diagnostic medical devices.
  • No issue/effective date is printed on this Version 1 form. Do not substitute this narrow route for a substantive modification or transfer authorization.
  • Bounded reading of the cited official original; no claim that every question aspect or later amendment has been exhausted.

Passage context: pdf-page-1 — Opening rule and instructions. See the independently pinned evidence references for every supporting page.

Conditions for this question

  • Only section 1.4 renaming of a foreign manufacturer/site address with no physical relocation.
  • Filing route and prior approval
  • Supporting documents

Foreign-address renaming without relocation

Fact-level verified

Section 1.4 covers a change in the address designation for a foreign manufacturer and/or foreign manufacturing site only when neither physically relocates. Attach a manufacturer letter stating the new address denomination, no relocation, and that all involved valid registrations (or registrations undergoing renewal) have the same manufacturer. The sheet lists affected registrations and asks that a copy be added to each registration’s background. The change is granted by foreign manufacturer and/or site.

Conditions
  • No inference for an office move, manufacturing relocation, new factory, country change or multiple different manufacturers.
  • Bounded reading of the cited official original; no claim that every question aspect or later amendment has been exhausted.

Passage context: pdf-page-3 — Section 1.4 and supporting letter; also pdf-page-7. See the independently pinned evidence references for every supporting page.

Conditions for this question

  • Foreign manufacturer/site address denomination only; same physical location.
  • Supporting documents

Minor communication form and evidence

Fact-level verified

The mandatory first sheet is a sworn declaration with applicant/device information. Select the applicable communication(s), meet every content-note condition, and give the date, full names and signatures of the legal representative and technical director. Append the applicable technical specifications/report, insert, immediate/outer labeling and other supporting material, and paginate the filing. General instructions file per sanitary registration; the foreign-address denomination sheet separately permits the qualifying same-manufacturer registrations to be listed.

Conditions
  • Supporting material depends on the selected eligible case; this is not an exhaustive substantive-change dossier.
  • Bounded reading of the cited official original; no claim that every question aspect or later amendment has been exhausted.

Passage context: pdf-page-1 — Mandatory instructions; section 1.4 sheet; also pdf-page-7. See the independently pinned evidence references for every supporting page.

Conditions for this question

  • Only when the particular event qualifies for the cited DIGEMID minor-change case; apply its separate case evidence.
Change control →Label, IFU & language →

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

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

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

Change control →Label, IFU & language →

Can several changes be filed together?

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

Verified guidance on

Read each rule with its scope and conditions.

  • Filing route and prior approval

Eligible minor-change communication route

Fact-level verified

DIGEMID Version 1 defines eligible minor changes as having no significant effect on device safety/performance. The registration holder submits the enumerated change in writing to ANM; it proceeds automatically without a separate authority pronouncement. This route covers only the form’s enumerated cases and all their stated conditions; authorized establishment changes already operate in corresponding registrations without a further communication except case 1.5.

Conditions
  • The title expressly includes medical devices and in-vitro diagnostic medical devices.
  • No issue/effective date is printed on this Version 1 form. Do not substitute this narrow route for a substantive modification or transfer authorization.
  • Bounded reading of the cited official original; no claim that every question aspect or later amendment has been exhausted.

Passage context: pdf-page-1 — Opening rule and instructions. See the independently pinned evidence references for every supporting page.

Conditions for this question

  • Each component must independently qualify among the enumerated minor communications.
  • Combined filing
  • Supporting documents

Foreign-address renaming without relocation

Fact-level verified

Section 1.4 covers a change in the address designation for a foreign manufacturer and/or foreign manufacturing site only when neither physically relocates. Attach a manufacturer letter stating the new address denomination, no relocation, and that all involved valid registrations (or registrations undergoing renewal) have the same manufacturer. The sheet lists affected registrations and asks that a copy be added to each registration’s background. The change is granted by foreign manufacturer and/or site.

Conditions
  • No inference for an office move, manufacturing relocation, new factory, country change or multiple different manufacturers.
  • Bounded reading of the cited official original; no claim that every question aspect or later amendment has been exhausted.

Passage context: pdf-page-3 — Section 1.4 and supporting letter; also pdf-page-7. See the independently pinned evidence references for every supporting page.

Conditions for this question

  • Only the specifically allowed list of valid/renewing registrations for the same foreign manufacturer and qualifying address denomination; not arbitrary multi-change consolidation.
  • Combined filing
  • Supporting documents

Selecting multiple eligible minor communications

Fact-level verified

The instructions permit selecting the communication(s) to make, require each to satisfy all its content-note conditions, and require each communication’s signatures/date. The general filing unit remains one sanitary registration, subject to the specific same-manufacturer foreign-address sheet. This supports multiple eligible minor communications on the form, not an unlimited consolidated application for substantive changes or a new registration.

Conditions
  • Bounded reading of the cited official original; no claim that every question aspect or later amendment has been exhausted.

Passage context: pdf-page-1 — Instructions: la(s) comunicación(es). See the independently pinned evidence references for every supporting page.

Conditions for this question

  • All proposed changes must independently fit the listed minor cases; respect the general per-registration unit and the explicit section 1.4 exception.
Change control →Dossier requirements →
Regulation codes

What these codes are

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.

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Keep Peru as the target market while you move into registration records, classification, cross-country product research, or pathway planning.

Classify a device for Peru

Check a preliminary DIGEMID risk class.

Search registered products

Inspect public DIGEMID records.

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Build a registration plan

Estimate pathway, government fees, preparation, and review time.

Build a reusable product master

Structure company, product, model, approval, and evidence facts once.

Map dossier reuse and deltas

Compare existing evidence against Peru needs.

Build a market-launch workpaper

Connect route, evidence, labels, representatives, and launch dependencies.

Assess a regulatory change

Test a current DIGEMID update against one product and its evidence.

Keep researching this market

More Peru medical device resources

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Tracked from official DIGEMID publications · row IDs are stable — cite as regulations:peru:device-minor-change-form-v1