Regulatory Medical Device Registration in Peru
- REGULATORY AUTHORITY: Medical devices are regulated by DIGEMID (Dirección General de Medicamentos, Insumos y Drogas). Read more (in Spanish).
- CLASSIFICATION SYSTEM: Devices are classified according to risk, following the EU model of Classes I, IIa, IIb, III, and IV.
- TIMEFRAME: The approval process takes about 4-5 months.
- VALIDITY: 5 years.
- AUTHORIZED REPRESENTATIVE: A local authorized representative (AR) is required to register medical devices in Peru. Your distributor must be your AR.
- ADDITIONAL INFORMATION: Registration in Peru must be conducted by an importer authorized by DIGEMID to hold a medical device license in Peru. The importer is fully responsible for the quality and traceability of imported products. Multiple importers are permitted.
We can assist with the preparation and submission of your product registration dossier file and application to DIGIMED. We will compile your technical and legal file, will review all labeling for compliance, and will provide post-submission assistance with DIGIMED all the way through the approval of the device registration.
This offering includes,
Unlimited regulatory and business strategy sessions with you.
Review of your market readiness (i.e., distributor partner program, contract, website, marketing material) and recommendations to successfully enter the market.
Review of technical and legal documentation, gap analysis and classification of your product.
Interaction with your local distributor to gather and review their legal documentation to attach to the dossier file.
Preparation and submission of the final dossier file to DIGIMED.
Answering post-submission follow-up questions from the DIGIMED reviewer.
*50% payable upon receipt of invoice, and remaining 50% payable upon submission to DIGIMED. If your product already has marketing authorization in the US, EU, Canada, Australia or Japan, DIGIMED will approve your product faster. For medical devices, pricing does not include cost of implementing or auditing a quality management system compliant with ISO 13485 or US FDA 21 CFR Part 820, if applicable.
This offering excludes:
DIGIMED fees: $450 to $650 depending on the classification. Fees are valid until december 2018 and are approximated due to exchange rate fluctuations.
- Document translations to Spanish. LATAM Market Access Inc. can translate these documents and will invoiced you at USD 0.25 per word in Spanish.
- Foreign documents which must be notarized/apostilled, such as your certificate of free sale/certificate to foreign government and letter of representation.