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Lowest Official Fees! One Registration Certificate for Multiple Importers! CMEF Latin America Open Class – Peru Session

Time：2026-10-30 11:03:33

Peru is a high-potential medical device market in South America, regulated by DIGEMID under a four-tier risk classification system aligned with IMDRF. Unlike Colombia and Mexico, Peru offers no simplified equivalence pathway; full technical review applies to all risk classes, yet its official registration fees are the lowest among the three jurisdictions. Based on the takeaways shared at the Beijing CMEF open class, this article outlines applicable regulations, classification rules, registration pathways, documentation, change control and vigilance requirements to deliver practical reference for overseas manufacturers.

一、Regulatory Framework Overview

Governing Authority: DIGEMID (General Directorate of Medicines, Medical Devices and Health Products), subordinate to MINSA (Ministry of Health). The DDMP Medical Devices Division conducts technical reviews.

Primary Legislation: Ley 29459 (Law of Medicines, Medical Devices and Health Products)

Core Implementing Rules: DS-016-2011-SA (registration administration); DS-003-2020-SA (risk classification rules); DS-014-2011-SA (establishment administration)

Registration Certificate: Resolución Directoral (Sanitary Registration Certificate), valid for 5 years, submitted electronically through the VUCE system.

二、Risk Classification (4-Tier IMDRF-Aligned System)

Risk Class	Risk Description	Review Timeline	Examples
Class I	Low risk, non-invasive, contact with intact skin	22 working days	General gloves, face masks, tongue depressors
Class II	Medium risk, contact with mucous membranes / short-term invasion (<30 days)	22 working days	Syringes, catheters, condoms
Class III	High risk, long-term invasion, energy-emitting devices	66 working days	Ventilators, anaesthesia machines, surgical lasers
Class IV	Very high risk, implanted devices, blood contact, central nervous system contact; drug-combination devices	66 working days	Heart stents, pacemakers, blood screening IVDs, drug-coated catheters

Key Rules: Devices with auxiliary medicinal components are directly classified as Class IV. Standalone SaMD starts at Class II; software supporting therapeutic decision-making is upgraded to Class III–IV. Peru has no RELIANCE-style equivalence pathway; a full review is mandatory for all products.

三、Registration Pathways

New Registration (Inscripción)：Corresponding TUPA codes by risk class (246 for Class I, 248 for Class II, 250 for Class III, 252 for Class IV).

Renewal (Reinscripción)：Applications due 1 year before expiry. Renewal official fees are approximately 95% of new registration fees. All pending variations must be closed prior to renewal. Class III / IV devices may be exempt from clinical trial reports.

Exceptional Import (Autorización Excepcional)：For unregistered products, compassionate clinical use may apply for temporary import. Compassionate use for individual patients can be cleared in as fast as 1 working day.

四、Local Representative & Qualification Requirements for Overseas Manufacturers

The Certificate Holder (Titular) must be a local Peruvian Droguería (import/distribution entity) or Laboratorio (manufacturer). Foreign manufacturers cannot hold the registration certificate directly.

Premises must hold an Autorización Sanitaria (Sanitary Operating Licence). Droguería importers must comply with BPA warehousing standards; manufacturing sites are subject to on-site inspection against BMP manufacturing standards.

Mandatory appointment of a Químico-Farmacéutico (Pharmaceutical Technical Responsible Person) holding a local practising licence and registered in the DIGEMID system.

Quality System: ISO 13485, CE and FDA certificates are accepted. For high-risk Class IV devices, FSC and ISO certificates must be issued within the preceding 12 months.

Labels and instructions for use must be in Spanish. Free Sale Certificate (CLC) requires Hague Apostille authentication.

五、Progressive Technical Documentation Requirements

Class I (Basic Package, 8 items)：Sworn application statement, FSC, ISO 13485, basic technical report, verification test reports, labelling and Spanish IFU. Risk management, clinical evidence and sterilisation validation are not required.

Class II (9 items, additional content)：Full Class I documentation + ISO 14971 risk management report + supplementary technical report (Chapter 6).

Class III (11 items, additional content)：Full Class II documentation + sterilisation validation for sterile products + complete clinical evaluation dossier.

Class IV (11 items, same scope as Class III with stricter validity rules)：Identical dossier scope as Class III. FSC and ISO 13485 certificates must be issued within 1 year.

Submission format：Electronic filing via VUCE + hard copy + non-rewritable CD-ROM.

六、Change Management: Minor Changes vs Major Changes

Minor Changes (Automatic Notification, No Prior Approval)：Label artwork, batch coding rules, overseas manufacturer name/address changes (without factory site alteration). Takes automatic effect once notification is submitted, and implementation must be completed within 6 months.

Major Changes (Prior Approval Mandatory, 30 working days, silent rejection rule, 8 categories)：Manufacturing site change, model / component modification, packaging material change, IFU revision, sterilisation method, shelf-life and storage condition revisions, etc. Changes cannot be implemented before approval.

Transfer of registration rights also requires official DIGEMID approval.

七、Additional Requirements

（一）Post-Market Surveillance (NTS 123 Medical Device Vigilance)

Fatal serious adverse events: Urgent notification within 24 hours, full technical report supplementary submission within 10 calendar days via the NotiMED platform.

Class III / IV high-risk devices require periodic safety update reports. Regulators may conduct market sampling and on-site warehouse inspections. Enterprises shall proactively implement product recalls.

（二）Reference Government Fees (PEN Soles)

Risk Class	New Registration Fee
Class I	S/ 1,348.50 (approx. CNY 2,700)
Class II	S/ 1,558.50
Class III	S/ 1,811.10
Class IV	S/ 2,051.00

八、Closing Remarks

Under the DIGEMID regulatory framework aligned with IMDRF rules, Peru offers a favourable filing route for domestic medical devices with existing international certifications. Nevertheless, requirements for local certificate holders, Spanish-language technical documentation, 5-year registration renewal and ongoing post-market surveillance cannot be overlooked. Compliance planning in advance is essential to reliably access the western South American market.Contact Wiselink for further inquiries!

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