DIGEMID (Peru)

The Dirección General de Medicamentos, Insumos y Drogas (DIGEMID) is Peru's General Directorate of Medicines, Supplies and Drugs within the Ministry of Health. It is the national authority responsible for medicines, medical devices, and related health products. Manufacturers seeking access to Peru interact with DIGEMID through a qualifying local pharmaceutical establishment and Peru's electronic trade procedures.

What does DIGEMID do for medical devices?

DIGEMID evaluates sanitary registration applications, authorizes and inspects pharmaceutical establishments, publishes technical requirements and alerts, and oversees market surveillance, vigilance, and enforcement. Medical device rules operate under Peru's health-product legislation, including Law No. 29459 and its implementing framework.

How are medical devices classified in Peru?

Peru uses Classes I, II, III, and IV, from lower to higher risk, and also regulates in vitro diagnostics. Classification determines the evidence and review pathway. Device characteristics such as invasiveness, duration of use, active function, sterility, measuring capability, and intended purpose should be assessed against the applicable rules.

Does a foreign manufacturer need a local registration holder?

Yes. A foreign manufacturer generally relies on a Peruvian pharmaceutical establishment with the appropriate authorization to hold the sanitary registration and conduct regulated activities. The local holder is central to submission, importation, distribution, authority communications, changes, vigilance, and recalls. Manufacturers should address data access, registration control, and transfer conditions in their agreement.

How is a DIGEMID application submitted?

Many foreign-trade procedures are submitted electronically through the Ventanilla Única de Comercio Exterior (VUCE), Peru's single-window platform. A dossier commonly includes legal and administrative documents, device identification and classification, manufacturer authorization, quality and conformity evidence, labeling and instructions, and safety and performance documentation. Product and class determine the exact route.

How can I search for registered devices?

DIGEMID provides a public medical device sanitary-registration search. Search carefully by product, holder, manufacturer, or registration number, and confirm the authorized scope and current status rather than relying only on a similar trade name.

Where are official forms and requirements published?

Use DIGEMID's official medical device registration page and its current forms and company-procedure resources. Fees, document formats, and administrative steps should be reconfirmed before filing.

Related Peru regulatory topics

See our Peru medical device registration overview for the broader market-entry process.