Medical Device Registration and Approval in Peru
Commercializing your medical device for sale in Peru requires registration with DIGEMID (Dirección General de Medicamentos, Insumos y Drogas), the country’s medical device regulator.
DIGEMID currently does not have a formal classification system in place, so a device’s classification in its country of origin is usually accepted by Peruvian regulators. A four-tier classification system is currently under consideration by the Peruvian government.
How we can help you register your medical device in Peru
With offices in Lima and throughout South America, Emergo can provide on-the-ground resources and expertise for foreign companies seeking to market their medical devices in Peru. We can fully support you in complying with guidance documents and regulations, preparing and submitting required registration materials to DIGEMID, and choosing qualified Peruvian distribution partners.
Our Peru registration service includes:
- Preparing your registration dossier and all application materials required by DIGEMID
- Translating the technical information required for the dossier into Spanish
- Evaluating scientific and technical information supporting your device’s safety and effectiveness
- Reviewing your proposed labeling and Instructions for Use materials in Spanish
- Providing guidance on clinical data and test results if necessary
- Providing guidance on applicable registration and renewal fees
Why choose Emergo to help you enter Peru?
Our office in Lima interacts closely with our offices in the US and Europe. We will manage your Peru medical device registration from our US or European office, and interact with regulators and distribution partners on your behalf.
- Our local presence in Lima enables us to efficiently liaise with DIGEMID as needed
- We can act as your Peru Registration Holder (PRH) if you have no local presence in the country
- Our consultants have helped clients successfully register their devices in more than 25 markets worldwide
- We can leverage your Peru registration to enter additional South American medical device markets depending on your business strategy