Consulting services for Peru and more information
Medical device manufacturers seeking market authorization in Peru must register with the Dirección General de Medicamentos, Drogas e Insumos (DIGEMID), a unit of the Peruvian Ministry of Health, unless the device type is exempt from registration. A Certificate of Free Sale (CFS) from the country of origin, country from which the devices are imported, or another recognized country is required for registration in Peru.
Let Passarini Regulatory Affairs assist you in evaluating the Peruvian medical device regulatory framework as it applies to your device(s).
Passarini’s worldwide network of consultants, industry contacts, and regulatory sources allows us to provide incisive analysis of multiple medical device markets, including Peru. Our Regulatory Pathway report service for Peru provides in-depth coverage of the following topics:
- DIGEMID Regulatory Background
- Product Assessment
- In-Country Representation in Peru
- Medical Device Registration Requirements
- Labeling and Language Requirements
- Costs and Timeframes
- Regulatory Roadmap for Peru
- Post-Market Obligations