Exporting medical devices to Peru requires adherence to the country’s registration process overseen by DIGEMID (Dirección General de Medicamentos, Insumos y Drogas), the regulatory authority. Here’s an overview of Peru’s medical device registration process:
- Registration Requirement: To commercialize medical devices in Peru, registration with DIGEMID is mandatory. This ensures compliance with local regulatory standards and enables market entry.
- Classification System: Medical devices and In Vitro Diagnostic (IVD) products in Peru are classified based on risk levels (Classes I, II, III, and IV). The classification criteria are aligned with international standards, similar to the European Directive 93/42/EEC, Annex IX.
- Submission of Application: Companies exporting medical devices to Peru must submit a comprehensive application to DIGEMID, including detailed product information, technical specifications, and manufacturing details.
- Compliance Evaluation: DIGEMID conducts a thorough assessment of the submitted documents to ensure compliance with Peru’s regulatory requirements. This may involve reviewing quality management systems, clinical data, and manufacturing practices.
- Inspection: In some cases, DIGEMID may conduct inspections of manufacturing facilities to verify compliance with Good Manufacturing Practices (GMP) and other regulatory standards.
- Review and Approval: Upon successful evaluation, DIGEMID reviews the application and grants approval for medical device registration, allowing the product to be marketed and distributed in Peru.
- Renewal: Medical device registrations in Peru typically require renewal after a specified period to maintain compliance with regulatory standards and ensure continued market access.
Navigating Peru’s medical device registration process requires careful attention to regulatory requirements and the timely submission of accurate documentation. Partnering with experienced regulatory consultants can streamline the registration process and expedite market entry for exporters.
How our services facilitate the registration process?
- Registration Dossier Preparation: We meticulously compile your registration dossier and all necessary application materials required by DIGEMID, ensuring compliance with Peruvian regulatory standards.
- Translation Services: Our expert translators adeptly translate technical information into Spanish, ensuring accuracy and clarity in your documentation submission.
- Scientific and Technical Evaluation: We conduct a comprehensive assessment of scientific and technical data supporting the safety and effectiveness of your medical device, enhancing the likelihood of registration approval.
- Labelling and Instructions Review: Our team reviews and adapts your labelling and Instructions for Use materials into Spanish, ensuring compliance with local language requirements and facilitating user understanding.
- Guidance on Clinical Data: If needed, we guide clinical data and test results, ensuring alignment with Peruvian regulatory expectations and facilitating registration approval.
- Fee Guidance: We offer insights into applicable registration and renewal fees, helping you navigate the financial aspects of the registration process effectively.
We also assure the requirement of documents should not be greater than two years date translated to Spanish.
By leveraging our services, companies can streamline the medical device registration process in Peru, ensuring compliance with local regulations and facilitating market access. Partner with us to navigate the complexities of registration and successfully introduce your products to the Peruvian market.
Timeframe and Local Fees (NEW APPLICATION)
| DEVICE TYPE |
TIMEFRAME |
LOCAL FEES (NEW APPLICATION) |
| Medical devices (class I) |
60 Days |
Approx. 400 euros |
| Medical devices (class II) |
90 Days |
Approx. 460 euros |
| Medical devices (class III) |
120 Days |
Approx. 510 euros |
| Medical devices (class IV) |
120 Days |
Approx. 580 euros |
Key documents are essential for medical device registration in Peru
- Product Information: Detailed information about the medical device, including its intended use, technical specifications, and manufacturing details, is crucial for registration in Peru.
- Quality Management System Certificate: Provide documentation certifying compliance with quality management system standards, such as ISO 13485, to demonstrate adherence to international quality standards.
- Certificate of Free Sale: A Certificate of Free Sale issued by the regulatory authority in your home country attests that the medical device is legally marketed and sold in your country of origin.
- Clinical Data: Depending on the risk classification of the medical device, clinical data demonstrating safety and efficacy may be required for registration in Peru.
- Manufacturing License: A valid manufacturing license from the regulatory authority in your home country is necessary to establish the legitimacy of the manufacturing process.
- If a device has been sterilized, the sterilization documentation, label, and IFU must indicate the device’s sterility status.
License Validity
The validity of licenses issued for medical devices registration in Peru typically spans 5 years. This is essential information for companies looking to export their products to Peru, ensuring they understand the timeline for maintaining compliance with regulatory requirements. Keeping track of license expiration dates is crucial to avoid any disruptions in market access and ensure the continued distribution of medical devices in Peru. By adhering to the stipulated validity period, companies can navigate the registration process effectively and maintain a seamless presence in the Peruvian market.
License Transfer
Companies exporting medical devices to Peru can transfer their registration licenses if needed. This process involves the holder of the registration certificate submitting a document known as the ownership assignment to initiate the transfer.
By understanding and adhering to the requirements for medical devices registration in Peru, companies can seamlessly navigate the process and ensure that their products meet regulatory standards for market entry.
