DIGEMID Peru Medical Device Registration

Medical devices and in vitro diagnostics supplied in Peru are regulated by the General Directorate of Medicines, Supplies and Drugs (DIGEMID), part of the Ministry of Health. Products generally need a sanitary registration before commercialization, and the Peruvian applicant must hold the establishment authorizations appropriate to its role. DIGEMID publishes current forms and requirements on its official medical device registration page.

Peru medical device classification

Peru uses a risk-based system with Classes I, II, III, and IV, from lower to higher risk. Classification considers intended use, invasiveness, duration of use, whether the product is active, and the potential harm if it fails. The class affects the evidence, review route, government fee, and maintenance obligations. IVD classification should be analyzed separately against the applicable Peruvian rules rather than inferred from a device classification in another country.

Local holder and submission route

A foreign manufacturer normally appoints a Peruvian company to act as the local registration holder and regulatory contact. The local party submits through the applicable government channel, responds to DIGEMID, imports or coordinates importation, and supports post-market actions. Authorization letters and agreements should clearly allocate dossier access, renewal duties, vigilance, change reporting, and the process for transferring a registration.

The submission commonly includes administrative forms, evidence of the manufacturer's legal status and quality system, a free-sale or market-authorization certificate where applicable, product descriptions, intended use, classification rationale, labeling, instructions for use, test reports, and clinical or performance evidence proportionate to risk. Spanish documentation and translations must be consistent with the approved product and claims.

After sanitary registration

Manufacturers and local holders should maintain the approved scope, models, sites, labeling, and technical evidence. Complaints, adverse events, recalls, and field safety corrective actions need defined escalation paths. A design, manufacturer, site, intended-use, or labeling change may require notification or prior approval; it should not be treated as an ordinary commercial update. Before shipment, verify the current registration record, validity, import documentation, and any batch or customs requirements with the local holder.