Peru DIGEMID Regulatory Requirements for Medical Devices and IVDs
Navigate Peru’s medical device registration with expert guidance and ensure compliance with DIGEMID requirements for a successful market entry.
Peru’s Growing Medical Device and IVD Market
Peru’s medical device and IVD market is small compared to others in Latin America. However, it’s expected to grow as Peruvian authorities work to modernize the healthcare system and improve access to quality care. The registration documentation process can be rigorous, especially for higher risk devices that must fulfil more comprehensive documentation requirements to verify their safety and efficacy. For manufacturers with authorizations in other markets, it may be possible to leverage some existing documentation and certifications to streamline authorization in Peru.
Regulatory authority
The General Directorate of Medicines, Supplies, and Drugs (DIGEMID), a division of the Ministry of Health, oversees the regulation of medical devices and IVDs in Peru. Manufacturers must obtain market authorization from DIGEMID before importing devices.
Device classification
Medical devices and IVDs are classified according to a set of rules that reference classification rules under the European Union and Global Harmonization Task Force. There are four tiers of increasing risk: Class I, II, III, and IV. Classification determines your registration documentation requirements and the potential review timeline for your product.
Registration process
Manufacturers seeking regulatory approval from DIGEMID must prepare and submit a dossier that includes technical documentation and product descriptions, manufacturing information, clinical and safety data, labeling and Instructions for Use, quality management system documentation, and market authorization from a recognized reference market (such as the US FDA or EU CE Mark certificate) or a Certificate of Free Sale (CFS)/ Certificate of Foreign Government (CFG) from their home country. Risk analyses and clinical evaluations may also be required depending on your device classification. DIGEMID assesses the submitted documentation and may request additional information. Once approved, the device receives a sanitary registration valid for five years.
Quality management system (QMS) requirements
Manufacturers must provide proof of a QMS that adheres to international quality standards, such as an ISO 13485 certificate.
In-country representation
Manufacturers based outside of Peru must appoint an in-country representative called a Peru Registration Holder (PRH). Your PRH acts as a liaison with DIGEMID, submits your device registration, and appears on your device’s labeling. The PRH must be licensed and have a physical address in Peru.
Support with DIGEMID Registration in Peru
Considering DIGEMID registration for your medical device or IVD? Our team of experts can help you strategize and coordinate market entry in Peru. Contact us to learn more about DIGEMID registration in Peru.