Peru is a key market on Latin America’s Pacific coast and the “next stop” for many medical device companies expanding overseas. Yet information about Peruvian registration online is mixed in quality, and much of it still copies outdated rules. This FAQ series of 20 questions and answers was compiled entirely against the original texts of official Peruvian regulations. The core basis is the newly published Unified Text of Administrative Procedures of the Ministry of Health (TUPA, Supreme Decree DS 011-2026-SA), which entered into force on July 21, 2026, together with Law No. 29459 (Ley N° 29459) and its implementing regulations. Every answer cites its regulatory source, so you are welcome to verify each item and discuss.
Part 1: Fundamentals – Get the Regulatory Framework Straight
Q1 Who is the competent authority for medical devices in Peru?
The national regulatory authority for medical devices in Peru is the Directorate General of Medicines, Supplies and Drugs (DIGEMID, Direccion General de Medicamentos, Insumos y Drogas), under the Peruvian Ministry of Health (MINSA). Pursuant to the Ministry of Health Organization and Functions Law (Legislative Decree No. 1161) and Article 84 of DS 008-2017-SA, DIGEMID is the National Authority for Medicines and Medical Devices (ANM) as defined by Law No. 29459, and is responsible nationwide for product registration, re-registration, amendments, suspension and revocation, as well as post-market control and health surveillance.
Regulatory basis: Article 5 of Law No. 29459; Article 84 of DS 008-2017-SA; cited portions of RD No. 063-2026-DIGEMID-DG-MINSA.
Q2 How does Peruvian regulation define a “medical device”? Does software count?
The definition in Article 4.3 of Law No. 29459 is: any instrument, apparatus, appliance, machine, in vitro reagent or calibrator, computer application (software), material or other similar or related item, intended by the manufacturer for use in humans, alone or in combination, for one or more of the following specific purposes: diagnosis, prevention, monitoring, treatment or alleviation of disease; diagnosis, monitoring, alleviation of or compensation for an injury; investigation, replacement, modification or support of an anatomical or physiological process; support or sustenance of life; contraception; and disinfection of medical devices.
Note: the definition expressly includes software (aplicativo informatico) and in vitro diagnostic reagents/calibrators, so its scope is broader than many companies expect.
Regulatory basis: Article 4.3 of Law No. 29459 (original text cited in RM No. 607-2024/MINSA official gazette).
Q3 How does Peru classify medical devices?
Peru uses a four-tier risk classification:
| Class | Risk level |
|---|---|
| Clase I | Low risk (de bajo riesgo) |
| Clase II | Moderate risk (de moderado riesgo) |
| Clase III | High risk (de alto riesgo) |
| Clase IV | Critical risk (criticos en materia de riesgo) |
Classification must follow the principles in Article 5 of DS 003-2020-SA (when multiple rules apply, take the highest class; combination products are classified by intended use; standalone software is classified separately or as part of a combination based on its intended use; if new risks are found after market entry, the ANM may require reclassification). The specific classification rules are set out in the 22 classification rules of Annex 1 (Anexo 1) of that regulation, which aligns broadly with the GHTF/IMDRF system – so for most products the Peruvian class follows the same logic as CE/FDA determinations, but you cannot copy them directly and must compare each product against the rules in Annex 1.
Regulatory basis: Article 6.2 of Law No. 29459; Articles 4, 5 and 6 and Annex 1 of DS 003-2020-SA.
Q4 Do all medical devices have to be registered?
No. Article 3 of DS 003-2020-SA makes clear that its scope applies to parties applying to DIGEMID for registration, re-registration or amendments; for some low-risk products, DIGEMID’s official website publishes a list of products that do not require sanitary registration (e.g. certain protective items), which must be checked item by item against the current list. In addition, for special situations such as urgent clinical need, the “exceptional import/use authorization for devices without a registration certificate” procedure listed in the TUPA is available.
Practical tip: when classification is unclear, first check DIGEMID’s official registration database (rsDispositivos) for registration records and risk classes of similar products in Peru – it is the most direct source of official precedent.
Regulatory basis: Article 3 of DS 003-2020-SA; exceptional import authorization procedure entries in DS 011-2026-SA (TUPA); DIGEMID official list.
Q5 Can a foreign manufacturer apply for registration itself? Must the registration holder (Titular) be a Peruvian company?
A local Peruvian entity is required. Article 22 of Law No. 29459 requires that entities engaged in manufacturing, importing, storing, distributing and similar activities be pharmaceutical establishments (establecimiento farmaceutico) holding a Sanitary Operating Authorization (Autorizacion Sanitaria de Funcionamiento) – in practice, usually a wholesaler (drogueria) or laboratory authorized by DIGEMID. The foreign manufacturer must apply through that local entity as the registration certificate holder (Titular).
Key point: the registration holder and the importer/distributor can be separated. The scope of authorization of the registration certificate itself covers “manufacture, import, storage, distribution, commercialization, promotion, dispensing, sale or use”, and the TUPA contains a separate “registration certificate transfer (Transferencia)” procedure. When signing contracts, it is advisable to design the “holder seat” and the “channel partner seat” separately at the contract level, to avoid being forced to re-register later when switching distributors.
Regulatory basis: Article 22 of Law No. 29459; DS 014-2011-SA; registration and transfer procedures in DS 011-2026-SA (TUPA).
Part 2: Registration in Practice – Documents, Fees and Timelines
Q6 What quality system documents are needed for registration? Can you apply without a DIGEMID BPM certificate?
Yes. The TUPA expressly accepts any one of the following documents as proof of quality system: (1) a GMP (BPM) certificate issued by the ANM (DIGEMID); or (2) other documents evidencing compliance with the quality specifications for that type of device, such as a valid EU CE certificate, a current ISO 13485 certificate, or FDA (registration), issued by the competent authority of the country of origin or a conformity assessment body. If the manufacturer already holds a valid BPM certificate issued by DIGEMID, simply enter the certificate number in the application form; no copy needs to be submitted.
For products manufactured in stages across multiple countries, proof of quality system must be submitted for every country involved in production.
Regulatory basis: original text of requirement items 2/3 of the registration procedures for each class in DS 011-2026-SA (TUPA).
Q7 What are the specific requirements for the Certificate of Free Sale (CFS)?
The TUPA requires submission of a copy of the Certificate of Free Sale (Certificado de Libre Comercializacion) issued by the competent authority of the country of origin or of export. Four practical details:
- Where the CFS does not cover all models (brands, models, codes, sizes, kit components, accessories), a confirmation letter issued by the manufacturer may be submitted to complete the correspondence;
- For contract manufacturing in a third country where the product is not marketed in the manufacturing country, the CFS issued by the competent authority of the commissioning export country should be submitted;
- For products manufactured in stages across multiple countries and marketed in one of them, submit the CFS of the country where the product is actually marketed;
- For localization scenarios such as a Peruvian local company commissioning manufacturing abroad, the CFS can be waived.
Regulatory basis: items a) to e) of requirement 2 of the registration procedures for each class in DS 011-2026-SA (TUPA).
Q8 What exactly differs in technical documentation across risk classes? One table to make it clear
Based on the 2026 new TUPA, the documentation requirements for registration by class are as follows:
| Document item | Class I | Class II | Class III | Class IV |
|---|---|---|---|---|
| Application form (declaration letter) + proof of payment | Yes | Yes | Yes | Yes |
| CFS | Yes | Yes | Yes | Yes |
| BPM/CE/ISO 13485/FDA or equivalent | Yes | Yes | Yes | Yes |
| Technical report (Informe tecnico, Article 130 of DS 016-2011-SA) | Items 1-4 | Items 1-4 and item 6 | Full text | Full text |
| Design verification/validation summary, declaration of conformity with international standards, finished product test certificate | Yes | Yes | Yes | Yes |
| Sterilization process validation report for sterile products | – | – | Yes (if applicable) | Yes (if applicable) |
| Draft Spanish-language inner/outer packaging labels | Yes | Yes | Yes | Yes |
| Risk management report (per current ISO standard, in practice ISO 14971) | – | Yes | Yes | Yes |
| Clinical evaluation report | – | – | Yes | Yes |
| Spanish-language instructions for use / package insert | Yes (if any) | Yes (if any) | Yes | Yes |
Three high-frequency pitfalls: (1) item 6 of Article 130 (essential safety and performance requirements documentation) is already required in advance for Classes II-IV before the device-specific regulation takes effect – do not miss it; (2) for Classes III/IV the clinical evaluation report is a mandatory submission; (3) for device-type products, submitting the corresponding pages of the catalog (catalogo) in place of instructions for use is also accepted (applicable to instrumental).
Regulatory basis: original requirement lists of Procedures No. 160, 164, 168 and 173 in DS 011-2026-SA (TUPA); Article 130 of DS 016-2011-SA.
Q9 What pathway do in vitro diagnostic reagents (IVDs) follow?
IVDs have a separate procedure (TUPA Procedure No. 177, “Sanitary Registration of In Vitro Diagnostic Medical Devices”), whose direct higher-level regulation is DS 010-97-SA. Requirements are relatively lean: application form, certificate of free sale or certificate of use, and proof of quality system (BPM or other equivalent documents; one per country for multi-country production). The procedure is decided by DIGEMID’s Directorate of Pharmaceutical Products (Direccion de Productos Farmaceuticos).
In addition, Peru is developing a dedicated IVD registration regulation (the draft was published for public comment in September 2024, see Q20), so IVD companies are advised to closely follow the legislative progress.
Regulatory basis: DS 010-97-SA; Procedure No. 177 of DS 011-2026-SA (TUPA); RM No. 607-2024/MINSA.
Q10 How much are the official fees? In what currency are they paid?
Current official fees (as set under the new TUPA in force since July 21, 2026, denominated in Peruvian soles S/, paid through VUCE):
| Procedure | First registration | Re-registration |
|---|---|---|
| Class I | S/ 1,438.70 | S/ 1,405.40 |
| Class II | S/ 1,593.20 | S/ 1,562.90 |
| Class III | S/ 1,948.40 | S/ 1,806.90 |
| Class IV | S/ 2,176.40 | S/ 2,138.40 |
| IVD | S/ 1,965.10 | S/ 1,915.10 |
| Registration amendment | S/ 646.70 (uniform fee) | – |
Payment channels: VUCE payment card/debit card/credit card, or bank channels such as BCP, Interbank, BBVA, Scotiabank and Citi. Note: the old fee figures circulating online such as “2724.90/3160/3490/3940” are no longer valid; follow DS 011-2026-SA.
Regulatory basis: Article 2 and the TUPA schedule of DS 011-2026-SA (published in the official gazette El Peruano on 2026-07-21).
Q11 What is the official review timeline? Does the application get automatically approved if the deadline passes?
Current statutory timelines (working days, dias habiles):
– Class I: 22 working days
– Class II: 44 working days
– Class III and Class IV: 66 working days each
– IVD: 30 working days
– Registration amendment: 30 working days
Important reminder – Peru applies negative administrative silence (Silencio Administrativo Negativo): if no response is received by the end of the period, the application is deemed NOT approved (not automatically granted!). The applicant may file an administrative appeal under the law. This is the exact opposite of markets with “implied approval after expiry”, so build ample buffer into your project schedule.
Regulatory basis: original text of the “timeline and procedure classification” field for each procedure in DS 011-2026-SA (TUPA).
Q12 Where do you submit? What does the process look like?
Two channels: online through the foreign trade single window VUCE (authorize.vuce.gob.pe, the “restricted goods” entry, requiring Clave SOL authentication), submitted as a SUCE (Unified Foreign Trade Application Form); or in person at DIGEMID (Av. Parque de las Leyendas 240, San Miguel, Lima), Monday to Friday 08:30-16:30. Technical review is handled by DIGEMID’s Directorate of Medical Devices and Sanitary Products (Direccion de Dispositivos Medicos y Productos Sanitarios), and approval is issued in the form of a ministerial-level resolution (Resolucion Directoral). Remedies after rejection: administrative reconsideration (reconsideracion: file within 15 working days / reply within 15 working days; apelacion: file within 15 working days / reply within 30 working days).
Regulatory basis: “submission channels / approving authority / remedy procedures” fields for each procedure in DS 011-2026-SA (TUPA); DS 008-2020-MINCETUR (implementing regulation of Law No. 30860).
Q13 What if DIGEMID requests corrections? Where can you verify a certificate after it is issued?
During review DIGEMID may issue observations (observaciones), which must be corrected within the given deadline under the general rules of the general administrative procedure law (TUO de la Ley No. 27444). Incomplete documentation is the main cause of delays – Spanish translation quality, the correspondence between the CFS and product information, and classification justification are the three most common correction points. After registration is granted, anyone can search the certificate status (valid VIGENTE / under re-registration / suspended / revoked) in the “Sanitary Registration Query for Medical Devices” database (rsDispositivos) on DIGEMID’s official website by registration number, product name, manufacturer, class, etc. It is recommended to verify here before tenders and customs clearance.
Regulatory basis: TUO de la Ley No. 27444 (DS 006-2026-JUS); DIGEMID rsDispositivos official database.
Part 3: Post-License Maintenance – Where Most Companies Stumble
Q14 How many years is a registration certificate valid? Why do many sources say 5 years?
According to the current official TUPA: Class I-IV device registration certificates are valid for 10 years from the date of issuance, extended by a further 10 years upon re-registration; IVD registration certificates are valid for 5 years. This is the original wording in the description field of each procedure in DS 011-2026-SA (“durante diez (10) anos contados desde la fecha de su otorgamiento”).
A large volume of third-party material (including many consultancies’ websites) still uses the old “5 years” wording or confuses devices with IVDs. Follow what is stated on the certificate and the current TUPA; for critical projects, obtain written confirmation from DIGEMID as the final basis.
Regulatory basis: original text of the description fields of Procedures No. 160/164/168/173 and No. 177 in DS 011-2026-SA (TUPA).
Q15 What does re-registration (Reinscripcion) require? Is it simpler than first registration?
Much simpler. For Class I, only the application form + proof of payment, the CFS and proof of quality system are required; for Class II and above, additionally the technical report, risk management report, design verification summary, label drafts, instructions for use, etc. – but all must be accompanied by a declaration letter stating that the documentation has not changed since first registration; if there are changes, they must be approved changes. In other words, re-registration presumes “clean change management”. Also, start re-registration as early as possible before expiry: once a registration certificate expires, the path back to legal sales is essentially a full re-registration.
Regulatory basis: requirement lists of Procedures No. 162/166/170/175/179 in DS 011-2026-SA (TUPA).
Q16 What if the product changes?
Use TUPA Procedure No. 181, “Amendment of the Sanitary Registration of Medical Devices”: official fee S/ 646.70, timeline 30 working days. Requirements are the application form + documents supporting the change (handled per the corresponding Articles 11, 15, 17, 19, 123, 132, 137, 138 and 140 of DS 016-2011-SA). Note: changes with a significant impact on quality, safety or efficacy must be approved before implementation; switching factories and changing models both fall within change management and cannot “cut corners” under the old certificate. After the change, remember to update the labels and IFU in sync and keep them consistent – many correction requests ultimately trace back to this.
Regulatory basis: Procedure No. 181 of DS 011-2026-SA (TUPA); Articles 11, 15, 17, 19, 123, 132, 137, 138 and 140 of DS 016-2011-SA.
Q17 What if you want to change the registration holder (switch agent/distributor)?
Use the “Registration Certificate Transfer (Transferencia de Registro Sanitario)” procedure: the current holder files the application (declaration letter + proof of payment), attaching documents evidencing the transfer (assignment/transfer of rights document). This is exactly where the value of “separating the holder from the channel” mentioned in Q5 pays off – if the certificate was initially held by the distributor and they refuse to sign the transfer documents, you will face a lose-lose situation of “the certificate cannot be recovered and a new one must be registered from scratch”. So lock in at the agreement stage from the beginning: holder independence, obligation to cooperate with transfer, document delivery and ownership of technical documentation.
Regulatory basis: requirement list of the registration certificate transfer procedure in DS 011-2026-SA (TUPA); relevant provisions of DS 016-2011-SA.
Q18 Can you import as soon as you hold the registration certificate? What else does importing require?
Not enough. The import/distribution entity must be a drogueria or laboratory holding a Sanitary Operating Authorization (Article 22 of Law No. 29459; DS 014-2011-SA), and must obtain the corresponding Good Storage Practices (BPA) certification for its scope of activities – the TUPA includes a dedicated “BPA certification/renewal for droguerias and specialized warehouses” procedure (based on Articles 110, 111 and 117-119 of DS 014-2011-SA), and cold-chain products additionally involve distribution and transport practices (BPDyT). Customs clearance is processed with the registration certificate / certificate issuance documents, and DIGEMID has a separate “issuance of product registration certificate” procedure for issuing certificates. In addition, droguerias and laboratories are obligated to report device sales prices to the National Price Information System (added in 2024, see Q20).
Regulatory basis: Articles 22 and 30 of Law No. 29459 (as amended by DS 020-2024-SA); Articles 110-119 of DS 014-2011-SA; BPA certification and certificate issuance procedures in DS 011-2026-SA (TUPA).
Q19 What ongoing obligations apply after market entry? Do adverse events have to be reported?
Yes, and this is the part that keeps a registration certificate “alive”. Peru has the Peruvian Pharmacovigilance and Technovigilance System (Sistema Peruano de Farmacovigilancia y Tecnovigilancia), led by DIGEMID under Article 35 of Law No. 29459, with operating rules in DS 013-2014-SA. As a member of the system, the registration holder must establish technovigilance responsibilities (including appointing a responsible person), report device adverse events (SIADM) and cooperate with DIGEMID safety notices and investigations; DIGEMID may take measures against non-compliant products such as immobilization (seizure), suspension or revocation of the registration certificate, and impose fines under the penalty rules (calculated in UIT) of Article 50 of Law No. 29459 and Annex 1 of DS 014-2011-SA. The holder must also ensure that labeling and promotional materials remain consistent with the approved registration content (advertising for prescription-only devices may target professionals only, see Articles 191-194 of DS 016-2011-SA).
Regulatory basis: Articles 35 and 50 of Law No. 29459; DS 013-2014-SA; Articles 191-194 of DS 016-2011-SA (as amended by DS 020-2024-SA); Annex 1 of DS 014-2011-SA.
Q20 What has recently changed in Peruvian medical device regulation? Where is the compliance window in the coming six months?
Three trends deserve every Peru registration holder’s attention:
1. Comprehensive update of procedures and fees: the new TUPA (DS 011-2026-SA) effective July 21, 2026 re-set all procedures, timelines and official fees (the data in Q10 and Q11 of this article) – all ongoing and planned projects should have budgets and schedules re-baselined under the new rules.
2. A device-specific regulation is in the legislative pipeline: in October 2024, the Ministry of Health published the “Draft Regulation on Registration, Control and Health Surveillance of Medical Devices” (RM No. 734-2024/MINSA) for a 90-day public comment period; the draft IVD-specific regulation was also circulated for comment in September 2024 (RM No. 607-2024/MINSA). As of October 2026, DIGEMID’s official regulatory library has not yet published the final approved text, but the legislative direction is clear: classification and essential safety and performance requirements (the “future application” clause of item 6 of Article 130 of DS 003-2020-SA) will be fully implemented. Documentation depth for Classes II-IV will increase significantly, so it is advisable to strengthen technical documentation in advance along ISO 14971 and clinical evaluation pathways.
3. Price transparency obligations: under Law No. 32033 and DS 020-2024-SA (amendments effective October 25, 2024), droguerias and laboratories must report price information to the National Medicines and Devices Price Information System, and registration holders must cooperate in generating product identification codes – a new compliance point many holders have not yet built into their SOPs.
Regulatory basis: DS 011-2026-SA; RM No. 734-2024/MINSA; RM No. 607-2024/MINSA; Law No. 32033; DS 020-2024-SA.
This article is general regulatory information and does not constitute legal advice. Peruvian regulations are under active revision; for specific projects, always follow DIGEMID’s latest official publications regarding procedures, official fees and documentation requirements. For key decisions, written confirmation from DIGEMID or consultation with a licensed local legal counsel is recommended.