The mandatory registration of Medical Devices in Peru is managed by the national regulatory authority: the Dirección General de Medicamentos, Insumos y Drogas (DIGEMID). The process is mainly regulated by Supreme Decree No. 016-2011-SA and its amendments, which establish the requirements for sanitary registration and the procedures necessary for market entry.

Registration Procedure

1. Application Submission
   Manufacturers without a local presence in Peru must submit the registration application through an Authorized Local Representative (Holder of the Sanitary Registration), duly registered and approved by DIGEMID. The application may be submitted online via the official DIGEMID platform or in person at their offices.
2. Dossier Evaluation
   DIGEMID evaluates the submitted technical dossier (Expediente Técnico). Depending on the device’s risk class, the evaluation process may vary.
   • Class I devices: usually only a notification or simplified registration is required.
   • Class II, III, and IV devices: a full evaluation of the technical dossier is required. DIGEMID may request additional documents, further testing, or clarifications.
3. Issuance of the Sanitary Registration Certificate
   After a successful evaluation and compliance with all requirements, DIGEMID issues the Sanitary Registration Certificate. This document is mandatory to import, market, and distribute Medical Devices in Peru.

Applicant

Foreign manufacturers must appoint an Authorized Local Representative, who acts as the Holder of the Sanitary Registration (Titular de Registro Sanitario), with the following responsibilities:

• Holds the legal ownership of the Sanitary Registration Certificate.
• Submits and manages the entire registration and renewal process with DIGEMID.
• Assumes legal responsibility for the device in the Peruvian market.
• Must have a legal presence in Peru and be registered with DIGEMID; it cannot simply be a foreign distributor without such authorization.

Registration Timelines and Costs

The time required to obtain the certificate may vary significantly:

• Class I devices: timelines are generally shorter, often within a few weeks.
• Class II and III devices: evaluation usually takes between 6 and 12 months on average, although the duration may vary depending on the device’s complexity and any additional requests for information from DIGEMID.
  Costs vary depending on the risk class and the administrative fees established by DIGEMID.

Certificate Validity

• The Sanitary Registration Certificate is valid for 5 years. Renewal must be requested within 90 days prior to its expiration date.

Documentation Language and Labeling

• Technical Documentation: Spanish.
• Labelling and IFU (Instructions for Use): Spanish.

Additional  Information

• The Holder of the Sanitary Registration is the legal owner of the registration. If the relationship with this local representative is terminated, the existing registration becomes invalid. To continue marketing the device, a new registration must be initiated with a new Holder. Therefore, choosing a local partner is critical.
• Any significant modification to the device (e.g., change in the manufacturing process, substantial design update) must be notified to DIGEMID and approved before implementation. In some cases, a new registration may be required.
• Post-market surveillance: It is a fundamental requirement that the Registration Holder manages post-market surveillance activities and reports any serious adverse events to DIGEMID.