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.
Medical device and IVD classification is determined by a rule-based system according to risk (Classes I, II, III, and IV). The classification rules are derived from the Global Harmonization Task Force guidance and are very similar to those set forth in the European Directive 93/42/EEC, Annex IX.
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.
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 U.S. and Europe. We will manage your Peru medical device registration from our U.S. 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 customers 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
Contact us to learn more about medical device registration in Peru.