DIGEMID · structured requirements

🇵🇪 Peru IVD regulatory data

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

9 facts4 dimensions2 official sourceslatest verification 2026-10-26

Changes after registration

Common questions about changing a registered IVD in Peru. Each question separates published rules from details still awaiting verification.

Does changing a device brand name or logo require an update? →Source-linked rules available
How do I update a manufacturer's name without changing the legal entity? →Source-linked rules available
What changes when the manufacturer's office address changes? →Source-linked rules available
Does a catalogue or reference code change affect registration or UDI? →Specific rules awaiting verification
Can a registration transfer to a different legal entity? →Source-linked rules available
Can several changes be filed together? →Source-linked rules available

Change control

Does the event require internal documentation, notice, prior approval, transfer, or a new application?

Compare countries

Domestic contract/staged laboratory name

qbd.domestic-contract-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.

Foreign-address renaming without relocation

qbd.foreign-address-denomination-no-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.

Eligible minor-change communication route

qbd.minor-communication-eligible-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.

Selecting multiple eligible minor communications

qbd.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.

Dossier requirements

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

Compare countries

Minor communication form and evidence

qbd.minor-communication-required-documents

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.

Label, IFU & language

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

Compare countries

Artwork-only label/IFU changes

qbd.minor-artwork-no-authorized-content-change

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.

Holder-label updates after an authorized transfer

qbd.post-transfer-holder-label-update

Fact-level verified

Section 1.3(3) also covers updating the new sanitary-registration holder’s details and/or the technical director’s name arising from a transfer, per registration. The corresponding sheet asks for the Resolución Directoral number for transfer cases. This is a post-transfer labeling communication; it does not establish who may transfer, the authorization procedure, reversibility, fees or transfer approval time.

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(3); transfer resolution field; also pdf-page-6. See the independently pinned evidence references for every supporting page.

Reliance & recognition

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

Compare countries

Existing records include acceptance, restrictions and evidence reuse. The applicable product scope and conditions are preserved below; a reference does not by itself confer market access.

Peru approvals and evidence in other markets (0 records)

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

Prior approvals and evidence for Peru (9 records)

PeruUS FDA · EU conformity assessment · Brazil ANVISA

Prior approval / evidence record

Class III

class-iii

Class Name

Class III

Risk Level

high

Pathway

Registration

Official Timeline

Min: 66
Max: 66
Unit: working-days

Verification Status

official-verified

Official Source

Title: DIGEMID TUPA (D.S. 011-2026-SA) — device procedure attention periods
Url: https://cdn.www.gob.pe/uploads/document/file/10349703/8409411-tupa-parte-2.pdf
Accessed Date: 2026-08-25

Realistic Timeline

Min: 6
Max: 12
Unit: months

With Prior Approval

Min: 4
Max: 7
Unit: months

Prior Approval Benefits

FDA 510(k)/PMA
EU CE Mark
ANVISA

Notes

TUPA (D.S. 011-2026-SA): Clase III within 66 business days; statutory parallel cap 90 calendar days (Art. 136)
Technical file review required

Clinical Trial Required

Local Testing Required

Gmp Required

Yes

DIGEMID TUPA (D.S. 011-2026-SA) — device procedure attention periods

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

PeruUS FDA · EU conformity assessment

Prior approval / evidence record

Class IV

class-iv

Class Name

Class IV

Risk Level

highest

Pathway

Full Registration

Official Timeline

Min: 66
Max: 66
Unit: working-days

Verification Status

official-verified

Official Source

Title: DIGEMID TUPA (D.S. 011-2026-SA) — device procedure attention periods
Url: https://cdn.www.gob.pe/uploads/document/file/10349703/8409411-tupa-parte-2.pdf
Accessed Date: 2026-08-25

Realistic Timeline

Min: 8
Max: 15
Unit: months

With Prior Approval

Min: 5
Max: 8
Unit: months

Prior Approval Benefits

FDA PMA
EU CE Mark Class III

Notes

TUPA (D.S. 011-2026-SA): Clase IV within 66 business days; statutory parallel cap 90 calendar days (Art. 136)
All device procedures carry negative administrative silence (no deemed approval on lapse)
Clinical data may be required

Clinical Trial Required

Yes

Local Testing Required

Gmp Required

Yes

DIGEMID TUPA (D.S. 011-2026-SA) — device procedure attention periods

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

PeruNMPA

Prior approval / evidence record

China NMPA approval: origin evidence only

reliance.china-nmpa-origin-evidence

Pending verification

Statement: For imported devices of every class, D.S. 016-2011-SA Arts. 124–127 numeral 2 require a copy of the free-sale certificate issued by the competent authority of the country of origin or of the exporter; an NMPA certificate therefore satisfies this requirement for China-made devices. Under Art. 21, a certificate issued by an authority that does not appear on DIGEMID's published list of competent authorities is valid only if legalized by the Peruvian consulate (or the exporting country's embassy in Peru) attesting that the issuer is the competent authority.
Source Jurisdiction Id: china
Source Authority Id: nmpa
Source Approval: China NMPA medical device registration certificate (Class II/III) or Class I filing record
Target Jurisdiction Id: peru
China Classes In Scope: NMPA Class I filings and Class II/III certificates for DIGEMID device classes I, II, III and IV
Edge Type: Origin Country Evidence
Market Access Strength: Evidence Only
Regulatory Layer: Product Marketing
Local Application Required: Yes
Target Decision Retained: Yes

Conditions

Applies to imported devices, classes I–IV
If the CLV does not list models/brand/codes/dimensions, a manufacturer letter is accepted
Art. 21 consular-legalization fallback where the issuing authority is not on DIGEMID's list
Independent verification is incomplete. Treat this record as a research lead, not a confirmed benefit or exclusion; see the 2026-09-15 independent review.

Effective from 2011-07-27

Source passage: 2. Copia del certificado de libre comercialización emitido por la Autoridad competente del país de origen o exportador, para productos importados. ... (Art. 21) Se tiene por válido el certificado ... emitido por la autoridad competente del país de origen o exportador distinta a la que figura en dicho listado, siempre que cuente con la legalización del consulado peruano del lugar ... que acredite que es la Autoridad Competente.

PeruNMPA

Regulatory reference

China NMPA approval: not reference

reliance.china-nmpa-not-reference

Pending verification

Statement: D.S. 016-2011-SA Art. 9 fixes the closed list of 'países de alta vigilancia sanitaria' used throughout the regulation (for example acceptance of foreign GMP certificates in Arts. 22–23 and information sources for safety actions in Art. 13): France, Netherlands, United Kingdom, United States, Canada, Japan, Switzerland, Germany, Spain, Australia, Denmark, Italy, Norway, Belgium and Sweden. China is not on the list, so NMPA approvals or GMP certificates carry no high-vigilance status before DIGEMID.
Source Jurisdiction Id: china
Source Authority Id: nmpa
Source Approval: China NMPA medical device registration certificate (Class II/III) or Class I filing record
Target Jurisdiction Id: peru
China Classes In Scope: NMPA Class II/III certificates; target DIGEMID device classes I–IV (references to 'países de alta vigilancia sanitaria' for GMP acceptance and product-evidence purposes)
Edge Type: No Reliance Route
Market Access Strength: none
Regulatory Layer: Product Marketing
Local Application Required: Yes
Target Decision Retained: Yes

Conditions

List is fixed by Art. 9 and may only change by Decreto Supremo
Arts. 22–23: foreign GMP certificates accepted only from high-vigilance countries or mutual-recognition countries
Independent verification is incomplete. Treat this record as a research lead, not a confirmed benefit or exclusion; see the 2026-09-15 independent review.

Effective from 2011-07-27

Source passage: Artículo 9°.- Países de alta vigilancia sanitaria. Para efectos de lo señalado en la Ley y el presente Reglamento, se consideran como países de alta vigilancia sanitaria los siguientes: Francia, Holanda, Reino Unido, Estados Unidos de América, Canadá, Japón, Suiza, Alemania, España, Australia, Dinamarca, Italia, Noruega, Bélgica y Suecia.

PeruUS FDA

Prior approval / evidence record

FDA 510(k)/PMA

Authority: FDA 510(k)/PMA
Accepted: Yes
Benefit: The United States is a high-surveillance country, so a US certificate of free sale and GMP certificate are accepted on the terms above.
Timeline Savings: None published

DIGEMID TUPA (D.S. 011-2026-SA) — device procedure attention periods Peru D.S. 016-2011-SA — Reglamento para el Registro, Control y Vigilancia Sanitaria de Productos Farmacéuticos, Dispositivos Médicos y Productos Sanitarios (arts. 7 and 9, as amended)

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

PeruUS FDA · EU conformity assessment · Brazil ANVISA

Prior approval / evidence record

Class II

class-ii

Class Name

Class II

Risk Level

medium

Pathway

Registration

Official Timeline

Min: 44
Max: 44
Unit: working-days

Verification Status

official-verified

Official Source

Title: DIGEMID TUPA (D.S. 011-2026-SA) — device procedure attention periods
Url: https://cdn.www.gob.pe/uploads/document/file/10349703/8409411-tupa-parte-2.pdf
Accessed Date: 2026-08-25

Realistic Timeline

Min: 4
Max: 8
Unit: months

With Prior Approval

Min: 3
Max: 5
Unit: months

Prior Approval Benefits

FDA 510(k)
EU CE Mark
ANVISA

Notes

TUPA (D.S. 011-2026-SA): Clase II within 44 business days; statutory parallel cap 60 calendar days (Art. 136)
CAN harmonization applies

Clinical Trial Required

Local Testing Required

Gmp Required

Yes

DIGEMID TUPA (D.S. 011-2026-SA) — device procedure attention periods

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

PeruBrazil ANVISA

Prior approval / evidence record

ANVISA (Brazil)

Authority: ANVISA (Brazil)
Accepted: No
Benefit: Brazil is neither a high-surveillance country under art. 9 nor a member of the Andean Community, so neither the documentary route nor CAN harmonisation applies to a Brazilian registration.
Timeline Savings: None

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

PeruEU conformity assessment

Prior approval / evidence record

EU CE Mark

Authority: EU CE Mark
Accepted: Yes
Benefit: Accepted where the certificate of free sale comes from one of the eleven EU or EFTA states on the high-surveillance list. A CE certificate from a notified body in a member state outside that list does not by itself carry the same standing.
Timeline Savings: None published

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

PeruUS FDA · UK MHRA · Health Canada · Japan MHLW / PMDA · Australia TGA · Swissmedic · South Korea MFDS · Germany · France · Netherlands · Spain · Italy · Belgium · Portugal · Ireland · Austria · Hungary · Denmark · Norway · Sweden

Prior approval / evidence record

País de Alta Vigilancia Sanitaria (art. 9 D.S. 016-2011-SA): United States, Canada, Japan, Australia, Switzerland, South Korea, United Kingdom, Germany, France, Netherlands, Spain, Italy, Belgium, Portugal, Ireland, Austria, Hungary, Denmark, Norway, Sweden

Authority: País de Alta Vigilancia Sanitaria (art. 9 D.S. 016-2011-SA): United States, Canada, Japan, Australia, Switzerland, South Korea, United Kingdom, Germany, France, Netherlands, Spain, Italy, Belgium, Portugal, Ireland, Austria, Hungary, Denmark, Norway, Sweden
Accepted: Yes
Benefit: The Peruvian route to relying on a foreign approval is documentary, not procedural. A certificate of free sale or a GMP certificate issued by a high-surveillance authority is accepted directly, and if the issuing authority appears on the Resolución Directoral 169-2014-DIGEMID list the document does not need an apostille. Everything else still goes through DIGEMID certification.
Timeline Savings: None published — the TUPA period is set by class, not by origin

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

Related structured datasets

Classification systems · 1 record

Open Risk classes I through IV. →

peru:medical-device

Jurisdiction Id

peru

Domains

medical-device
ivd

Name

Risk classes I through IV.

Classes

Id
i
Label
Class I
Normalized Risk Level
low
Id
ii
Label
Class II
Normalized Risk Level
medium
Id
iii
Label
Class III
Normalized Risk Level
high
Id
iv
Label
Class IV
Normalized Risk Level
highest

Regulator

DIGEMID

Official Domains

digemid.minsa.gob.pe
gob.pe
cdn.www.gob.pe

Source Status

official-source-verified

Source Title

Decreto Supremo 003-2020-SA, Arts. 4-6 y Anexo 1 (reglas de clasificación)

Source Url

https://cdn.www.gob.pe/uploads/document/file/521021/decreto-supremo-003-2020-SA.PDF

Verified On

2026-08-25

Source Supports

class-axis
classification-rules

Notes

Four classes per Art. 4 (I bajo, II moderado, III alto, IV crítico), consistent with Ley 29459 Art. 6 and D.S. 016-2011-SA; GHTF-derived rules in Anexo 1; the highest applicable rule governs when two or more rules apply.
The manufacturer classifies (Art. 6) and the ANM may reclassify; accessories and combination components are classified separately.
Software: software influencing another device is classified by the combination's intended use; standalone software is an active medical device (D.S. 016-2011-SA Art. 122 as complemented by software rules d.1/d.2).

Registration pathways, prior approvals and planning · 1 record

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

Open Peru registration →

Country

Peru

Jurisdiction Id

peru

Country Code

Flag

🇵🇪

Regulator

Dirección General de Medicamentos, Insumos y Drogas

Regulator Abbrev

DIGEMID

Region

americas

Tier

Risk Classification

4-class (I, II, III, IV)

Classes

Id
class-i
Class Name
Class I
Risk Level
low
Pathway
Notification
Official Timeline
Min
22
Max
22
Unit
working-days
Verification Status
official-verified
Official Source
Title
DIGEMID TUPA (D.S. 011-2026-SA) — device procedure attention periods
Url
https://cdn.www.gob.pe/uploads/document/file/10349703/8409411-tupa-parte-2.pdf
Accessed Date
2026-08-25
Realistic Timeline
Min
2
Max
4
Unit
months
Notes
TUPA (D.S. 011-2026-SA): Clase I inscripción/reinscripción attended within 22 business days
Statutory calendar-day cap still in force in parallel: 30 calendar days (D.S. 016-2017-SA Art. 136)
Simplified notification process
Clinical Trial Required
No
Local Testing Required
No
Gmp Required
No
Id
class-ii
Class Name
Class II
Risk Level
medium
Pathway
Registration
Official Timeline
Min
44
Max
44
Unit
working-days
Verification Status
official-verified
Official Source
Title
DIGEMID TUPA (D.S. 011-2026-SA) — device procedure attention periods
Url
https://cdn.www.gob.pe/uploads/document/file/10349703/8409411-tupa-parte-2.pdf
Accessed Date
2026-08-25
Realistic Timeline
Min
4
Max
8
Unit
months
With Prior Approval
Min
3
Max
5
Unit
months
Prior Approval Benefits
FDA 510(k)
EU CE Mark
ANVISA
Notes
TUPA (D.S. 011-2026-SA): Clase II within 44 business days; statutory parallel cap 60 calendar days (Art. 136)
CAN harmonization applies
Clinical Trial Required
No
Local Testing Required
No
Gmp Required
Yes
Id
class-iii
Class Name
Class III
Risk Level
high
Pathway
Registration
Official Timeline
Min
66
Max
66
Unit
working-days
Verification Status
official-verified
Official Source
Title
DIGEMID TUPA (D.S. 011-2026-SA) — device procedure attention periods
Url
https://cdn.www.gob.pe/uploads/document/file/10349703/8409411-tupa-parte-2.pdf
Accessed Date
2026-08-25
Realistic Timeline
Min
6
Max
12
Unit
months
With Prior Approval
Min
4
Max
7
Unit
months
Prior Approval Benefits
FDA 510(k)/PMA
EU CE Mark
ANVISA
Notes
TUPA (D.S. 011-2026-SA): Clase III within 66 business days; statutory parallel cap 90 calendar days (Art. 136)
Technical file review required
Clinical Trial Required
No
Local Testing Required
No
Gmp Required
Yes
Id
class-iv
Class Name
Class IV
Risk Level
highest
Pathway
Full Registration
Official Timeline
Min
66
Max
66
Unit
working-days
Verification Status
official-verified
Official Source
Title
DIGEMID TUPA (D.S. 011-2026-SA) — device procedure attention periods
Url
https://cdn.www.gob.pe/uploads/document/file/10349703/8409411-tupa-parte-2.pdf
Accessed Date
2026-08-25
Realistic Timeline
Min
8
Max
15
Unit
months
With Prior Approval
Min
5
Max
8
Unit
months
Prior Approval Benefits
FDA PMA
EU CE Mark Class III
Notes
TUPA (D.S. 011-2026-SA): Clase IV within 66 business days; statutory parallel cap 90 calendar days (Art. 136)
All device procedures carry negative administrative silence (no deemed approval on lapse)
Clinical data may be required
Clinical Trial Required
Yes
Local Testing Required
No
Gmp Required
Yes

Prior Approvals

Authority
País de Alta Vigilancia Sanitaria (art. 9 D.S. 016-2011-SA): United States, Canada, Japan, Australia, Switzerland, South Korea, United Kingdom, Germany, France, Netherlands, Spain, Italy, Belgium, Portugal, Ireland, Austria, Hungary, Denmark, Norway, Sweden
Accepted
Yes
Benefit
The Peruvian route to relying on a foreign approval is documentary, not procedural. A certificate of free sale or a GMP certificate issued by a high-surveillance authority is accepted directly, and if the issuing authority appears on the Resolución Directoral 169-2014-DIGEMID list the document does not need an apostille. Everything else still goes through DIGEMID certification.
Timeline Savings
None published — the TUPA period is set by class, not by origin
Authority
FDA 510(k)/PMA
Accepted
Yes
Benefit
The United States is a high-surveillance country, so a US certificate of free sale and GMP certificate are accepted on the terms above.
Timeline Savings
None published
Authority
EU CE Mark
Accepted
Yes
Benefit
Accepted where the certificate of free sale comes from one of the eleven EU or EFTA states on the high-surveillance list. A CE certificate from a notified body in a member state outside that list does not by itself carry the same standing.
Timeline Savings
None published
Authority
ANVISA (Brazil)
Accepted
No
Benefit
Brazil is neither a high-surveillance country under art. 9 nor a member of the Andean Community, so neither the documentary route nor CAN harmonisation applies to a Brazilian registration.
Timeline Savings
None

Key Requirements

Peru Registration Holder (for foreign manufacturers)
Spanish labeling and IFU
Free Sale Certificate
GMP certificate
Technical documentation
IVD registration/reinscription: 30 business days (TUPA); cambios (modifications): 30 business days; appeal windows per TUPA recursos rows

Local Rep Required

Yes

Local Rep Name

Peru Registration Holder

Mdsap Accepted

Mdsap Benefit

Not accepted. The GMP evidence DIGEMID accepts without further certification is a certificate from a high-surveillance authority, not an MDSAP report.

Registration Validity

5 years from the date of grant for every product and device in scope (art. 7 D.S. 016-2011-SA). Once the term lapses without reinscription DIGEMID places no restriction on continued use of biomedical equipment already acquired during the term.

Verification Status

official-verified

Official Sources

Title
DIGEMID TUPA (D.S. 011-2026-SA) — device procedure attention periods
Url
https://cdn.www.gob.pe/uploads/document/file/10349703/8409411-tupa-parte-2.pdf
Accessed Date
2026-08-25
Title
Peru D.S. 016-2011-SA — Reglamento para el Registro, Control y Vigilancia Sanitaria de Productos Farmacéuticos, Dispositivos Médicos y Productos Sanitarios (arts. 7 and 9, as amended)
Url
https://www.gob.pe/institucion/minsa/normas-legales/243290-016-2011-sa
Accessed Date
2026-08-30

Reviewed On

2026-08-30

Last Updated

2026-08-30

Process

Template Id

default

Status

planning-template

Usage Rule

Maintained planning steps and estimates, not verified regulator deadlines.

Steps

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

Government fee schedules · 1 record

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

Open Peru fees →

Jurisdiction Id

peru

Country

Peru

Country Code

Authority

DIGEMID / VUCE

Low Risk Local

Min: 1438.7
Max: 1438.7
Currency: PEN
Per Product: No

High Risk Local

Min: 2176.4
Max: 2176.4
Currency: PEN
Per Product: No

Details

Id
registration-class-1
Item
Registration (inscripción) - Class I medical device
Currency
PEN
Amount Local
1438.7
Amount Local Formatted
PEN 1,438.70
Frequency
Per application (procedure PA990006DD)
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://cdn.www.gob.pe/uploads/document/file/10349703/8409411-tupa-parte-2.pdf
Source Title
Peru TUPA D.S. 011-2026-SA, Parte 2: medical-device registration procedures
Source Effective Date
2026-07-21
Verified On
2026-08-25
Id
re-registration-class-1
Item
Re-registration (reinscripción) - Class I medical device
Currency
PEN
Amount Local
1405.4
Amount Local Formatted
PEN 1,405.40
Frequency
Per application (procedure PA9900DDA7)
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://cdn.www.gob.pe/uploads/document/file/10349703/8409411-tupa-parte-2.pdf
Source Title
Peru TUPA D.S. 011-2026-SA, Parte 2: medical-device registration procedures
Source Effective Date
2026-07-21
Verified On
2026-08-25
Id
registration-class-2
Item
Registration - Class II medical device
Currency
PEN
Amount Local
1593.2
Amount Local Formatted
PEN 1,593.20
Frequency
Per application (procedure PA99008E39)
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://cdn.www.gob.pe/uploads/document/file/10349703/8409411-tupa-parte-2.pdf
Source Title
Peru TUPA D.S. 011-2026-SA, Parte 2: medical-device registration procedures
Source Effective Date
2026-07-21
Verified On
2026-08-25
Id
re-registration-class-2
Item
Re-registration - Class II medical device
Currency
PEN
Amount Local
1562.9
Amount Local Formatted
PEN 1,562.90
Frequency
Per application (procedure PA990012F8)
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://cdn.www.gob.pe/uploads/document/file/10349703/8409411-tupa-parte-2.pdf
Source Title
Peru TUPA D.S. 011-2026-SA, Parte 2: medical-device registration procedures
Source Effective Date
2026-07-21
Verified On
2026-08-25
Id
registration-class-3
Item
Registration - Class III medical device (high risk)
Currency
PEN
Amount Local
1948.4
Amount Local Formatted
PEN 1,948.40
Frequency
Per application (procedure PA990049F8)
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://cdn.www.gob.pe/uploads/document/file/10349703/8409411-tupa-parte-2.pdf
Source Title
Peru TUPA D.S. 011-2026-SA, Parte 2: medical-device registration procedures
Source Effective Date
2026-07-21
Verified On
2026-08-25
Id
re-registration-class-3
Item
Re-registration - Class III medical device
Currency
PEN
Amount Local
1806.9
Amount Local Formatted
PEN 1,806.90
Frequency
Per application (procedure PA9900B054)
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://cdn.www.gob.pe/uploads/document/file/10349703/8409411-tupa-parte-2.pdf
Source Title
Peru TUPA D.S. 011-2026-SA, Parte 2: medical-device registration procedures
Source Effective Date
2026-07-21
Verified On
2026-08-25
Id
registration-class-4
Item
Registration - Class IV medical device (critical risk)
Currency
PEN
Amount Local
2176.4
Amount Local Formatted
PEN 2,176.40
Frequency
Per application (procedure PA99006495)
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://cdn.www.gob.pe/uploads/document/file/10349703/8409411-tupa-parte-2.pdf
Source Title
Peru TUPA D.S. 011-2026-SA, Parte 2: medical-device registration procedures
Source Effective Date
2026-07-21
Verified On
2026-08-25
Id
re-registration-class-4
Item
Re-registration - Class IV medical device
Currency
PEN
Amount Local
2138.4
Amount Local Formatted
PEN 2,138.40
Frequency
Per application (procedure PA990011832)
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://cdn.www.gob.pe/uploads/document/file/10349703/8409411-tupa-parte-2.pdf
Source Title
Peru TUPA D.S. 011-2026-SA, Parte 2: medical-device registration procedures
Source Effective Date
2026-07-21
Verified On
2026-08-25
Id
registration-ivd
Item
Registration - in-vitro diagnostic device
Currency
PEN
Amount Local
1965.1
Amount Local Formatted
PEN 1,965.10
Frequency
Per application (procedure PA990002F5)
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://cdn.www.gob.pe/uploads/document/file/10349703/8409411-tupa-parte-2.pdf
Source Title
Peru TUPA D.S. 011-2026-SA, Parte 2: medical-device registration procedures
Source Effective Date
2026-07-21
Verified On
2026-08-25
Id
re-registration-ivd
Item
Re-registration - in-vitro diagnostic device
Currency
PEN
Amount Local
1915.1
Amount Local Formatted
PEN 1,915.10
Frequency
Per application (procedure PA990033E4)
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://cdn.www.gob.pe/uploads/document/file/10349703/8409411-tupa-parte-2.pdf
Source Title
Peru TUPA D.S. 011-2026-SA, Parte 2: medical-device registration procedures
Source Effective Date
2026-07-21
Verified On
2026-08-25
Id
registration-change-significant
Item
Change to the sanitary registration - significant repercussion on quality, safety, or efficacy
Currency
PEN
Amount Local
646.7
Amount Local Formatted
PEN 646.70
Frequency
Per application (procedure PA9900E4FF)
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://cdn.www.gob.pe/uploads/document/file/10349703/8409411-tupa-parte-2.pdf
Source Title
Peru TUPA D.S. 011-2026-SA, Parte 2: medical-device registration procedures
Source Effective Date
2026-07-21
Verified On
2026-08-25

Notes

TUPA D.S. 011-2026-SA has applied since its publication on 21 July 2026 and lists these exact amounts for the DIGEMID device procedures in VUCE.
Amounts are payable at the entidad cashier (Caja de la Entidad) per procedure code shown in the frequency field.
Import, export, and certificate procedures carry separate TUPA rows not listed here.

Last Updated

2026-08-25

Verification Status

official-verified

Official Sources

Title
Peru TUPA D.S. 011-2026-SA, Parte 2: medical-device registration procedures
Url
https://cdn.www.gob.pe/uploads/document/file/10349703/8409411-tupa-parte-2.pdf
Effective Date
2026-07-21
Accessed Date
2026-08-25
Title
Peru VUCE TUPA 119: sanitary-registration certificate for pharmaceuticals and medical devices
Url
https://www.vuce.gob.pe/Paginas/Catalogo-de-servicios-detalle.aspx?idCategoria=3&idDetalle=325
Accessed Date
2026-08-25

Reviewed On

2026-08-25

Amount Status

exact-current

Range Available

Yes

Additional certifications and licences · 1 record

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

Open Peru certifications →

Slug

peru

Market

Peru

Confidence

low

Schemes

Id
digemid-electrical-emc-evidence
Name
DIGEMID electrical/EMC evidence
Category
Medical Electrical Safety
Status
Included In Medical Registration
Object
Finished Device
Note
Registration accepts quality-system evidence in lieu of Peruvian BPM: EC (CE) certificate, current ISO 13485, FDA or others by risk level issued by the country-of-origin authority (D.S. 016-2017-SA Art. 126 num. 3); sterile class III/IV devices submit sterilization-process validation reports (Art. 126 num. 6); classes II-IV need an ISO-specific risk-management report (Arts. 125 num. 7 / 126 num. 8).
Source Urls
https://www.digemid.minsa.gob.pe/Archivos/Normatividad/2017/DS_016-2017.pdf
Source Binding
reviewed
Id
mtc-rf-emitting-equipment-homologation
Name
MTC RF-emitting equipment homologation
Category
Radio Spectrum
Status
Mandatory If Feature
Object
Radio Emitting Equipment
Source Urls
https://www.gob.pe/institucion/mtc/colecciones/334-homologacion-de-equipos-de-telecomunicaciones
Source Binding
candidate
Id
mtc-public-network-equipment-homologation
Name
MTC public-network equipment homologation
Category
Telecom Network Attachment
Status
Mandatory If Feature
Object
Public Network Terminal
Source Urls
https://www.gob.pe/institucion/mtc/colecciones/334-homologacion-de-equipos-de-telecomunicaciones
Source Binding
candidate
Id
ipen-radiation-authorization
Name
IPEN radiation authorization
Category
Ionizing Radiation
Status
Mandatory If Feature
Object
Product And Use Site
Note
D.S. 016-2011-SA Art. 24 num. 7: registration of ionizing-radiation emitting controlled-technology biomedical equipment requires a copy of the IPEN (Instituto Peruano de Energía Nuclear) import authorization.
Source Urls
https://www.digemid.minsa.gob.pe/Archivos/Normatividad/2011/DS_016-2011.pdf
Source Binding
candidate

Official Sources

Authority
MTC
Topic
telecommunications equipment homologation collection
Url
https://www.gob.pe/institucion/mtc/colecciones/334-homologacion-de-equipos-de-telecomunicaciones
Authority
MTC
Topic
RF-emitting equipment certificate
Url
https://www.gob.pe/institucion/mtc/pages/22738-solicitar-certificado-de-homologacion-para-un-equipo-y-o-aparato-de-telecomunicaciones-que-genera-emisiones-radioelectricas
Authority
DIGEMID
Topic
D.S. 016-2017-SA registration dossier quality-system and sterilization evidence
Url
https://www.digemid.minsa.gob.pe/Archivos/Normatividad/2017/DS_016-2017.pdf
Authority
DIGEMID
Topic
D.S. 016-2011-SA IPEN import authorization for radiation equipment
Url
https://www.digemid.minsa.gob.pe/Archivos/Normatividad/2011/DS_016-2011.pdf

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Pricing

Changes after registration

Change control

Domestic contract/staged laboratory name

Foreign-address renaming without relocation

Eligible minor-change communication route

Selecting multiple eligible minor communications

Dossier requirements

Minor communication form and evidence

Label, IFU & language

Artwork-only label/IFU changes

Holder-label updates after an authorized transfer

Reliance & recognition

Peru approvals and evidence in other markets (0 records)

Prior approvals and evidence for Peru (9 records)

Class III

Class IV

China NMPA approval: origin evidence only

China NMPA approval: not reference

FDA 510(k)/PMA

Class II

ANVISA (Brazil)

EU CE Mark

País de Alta Vigilancia Sanitaria (art. 9 D.S. 016-2011-SA): United States, Canada, Japan, Australia, Switzerland, South Korea, United Kingdom, Germany, France, Netherlands, Spain, Italy, Belgium, Portugal, Ireland, Austria, Hungary, Denmark, Norway, Sweden

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