{"id":34740,"date":"2025-10-08T16:56:02","date_gmt":"2025-10-08T14:56:02","guid":{"rendered":"https:\/\/www.thema-med.com\/?page_id=34740"},"modified":"2025-10-10T09:11:47","modified_gmt":"2025-10-10T07:11:47","slug":"medical-device-registration-in-peru","status":"publish","type":"page","link":"https:\/\/www.thema-med.com\/en\/medical-device-registration-in-peru\/","title":{"rendered":"Medical Device Registration in Peru"},"content":{"rendered":"

<\/span><\/div>
Regulatory Authority<\/b><\/h5>\n

Direcci\u00f3n General de Medicamentos, Insumos y Drogas<\/em> (DIGEMID \u2013 MINSA). DIGEMID is the body of the Ministry of Health responsible for the regulation, control, and surveillance of medicines, medical devices, and health products in Peru.<\/p>\n

Classification<\/strong><\/h5>\n

Class I, II, III, IV<\/p>\n

Quality system<\/b><\/h5>\n

ISO 13485:2016
Local GMP (Buenas Pr\u00e1cticas de Fabricaci\u00f3n<\/em>) required by DIGEMID<\/p>\n

<\/p>\n

<\/p>\n

<\/p>\n

<\/p>\n<\/div>

<\/i><\/span>The information on this page is valid and current as of October 2025. The legislative and regulatory provisions are subject to changes and updates by the Regulatory Authorities of the State to which they refer. Considering the above, the writer declines all responsibility regarding any non-actuality and\/or inaccuracy of the information received concurrently with or following the publication of this page Disclaimer<\/a><\/strong><\/em><\/span><\/div><\/div><\/div><\/div>

The mandatory registration of medical devices in Peru is managed by the national regulatory authority: the Direcci\u00f3n General de Medicamentos, Insumos y Drogas<\/em> (DIGEMID). The process is mainly regulated by Supreme Decree No. 016-2011-SA<\/strong> and its amendments, which establish the requirements for sanitary registration and the procedures necessary for market entry.<\/p>\n

Registration Procedure<\/strong><\/h3>\n
    \n
  1. Application Submission
    <\/strong>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.<\/li>\n
  2. Dossier Evaluation
    <\/strong>DIGEMID evaluates the submitted technical dossier (Expediente T\u00e9cnico<\/em>). Depending on the device\u2019s risk class, the evaluation process may vary.\n
      \n
    • Class I devices: usually only a notification or simplified registration is required.<\/li>\n<\/ul>\n
        \n
      • Class II, III, and IV devices: a full evaluation of the technical dossier is required. DIGEMID may request additional documents, further testing, or clarifications.<\/li>\n<\/ul>\n<\/li>\n
      • Issuance of the Sanitary Registration Certificate
        <\/strong>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.<\/li>\n<\/ol>\n

        Applicant<\/strong><\/h3>\n

        Foreign manufacturers must appoint an Authorized Local Representative<\/strong>, who acts as the Holder of the Sanitary Registration (Titular de Registro Sanitario<\/em><\/strong>), with the following responsibilities:<\/p>\n

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

          Registration Timelines and Costs<\/strong><\/h3>\n

          The time required to obtain the certificate may vary significantly:<\/p>\n

            \n
          • Class I devices: timelines are generally shorter, often within a few weeks.<\/li>\n
          • Class II and III devices: evaluation usually takes between 6 and 12 months on average, although the duration may vary depending on the device\u2019s complexity and any additional requests for information from DIGEMID.
            Costs vary depending on the risk class and the administrative fees established by DIGEMID.<\/li>\n<\/ul>\n

            Certificate Validity<\/strong><\/h3>\n
              \n
            • The Sanitary Registration Certificate is valid for 5 years. Renewal must be requested within 90 days prior to its expiration date.<\/li>\n<\/ul>\n

              Documentation Language and Labeling<\/strong><\/h3>\n
                \n
              • Technical Documentation: Spanish.<\/li>\n
              • Labelling and IFU (Instructions for Use): Spanish.<\/li>\n<\/ul>\n

                Additional\u00a0 Information<\/strong><\/h3>\n
                  \n
                • 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.<\/li>\n
                • 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.<\/li>\n
                • 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.<\/li>\n<\/ul>\n

                  <\/p>\n

                  <\/p>\n<\/div><\/div><\/div><\/div><\/div>

                  <\/div><\/div>
                  \n
                  \n

                  <\/p>

                    <\/ul><\/div>\n
                    \n
                    \n<\/fieldset>\n

                    Do you want to market your Medical Device in this Country? Contact us!\n<\/h3>\n