Companies interested in selling their medical devices in Peru must appoint a Peru Registration Holder (PRH) to manage their registrations if they have no local presence in the country. A PRH is responsible for submitting your registration application materials to the Peruvian market regulator, DIGEMID, and interacting with them on your behalf. Your PRH must also have a drugstore license and a licensed pharmacist on staff.
Emergo is a registered PRH with DIGEMID and provides in-country representation for medical device companies selling in Peru. As your PRH, our priority will be your success in Peru.
What our Peru registration holder service includes
Emergo provides in-country representation for medical device companies entering the Peruvian market. As your PRH, we will provide you with comprehensive and truly independent authorized representation in Peru. Our service includes:
- Providing your device information and documentation to DIGEMID for review and approval
- Coordinating all inquiries, analysis and responses for reportable events involving your device
- Serving as a liaison between you and DIGEMID in instances where device recalls are necessary
- Assisting with your device registration renewal (required every five years in Peru)
Why trust Emergo as your Peru registration holder?
Some medical device manufacturers choose to appoint their distributor as their Peru Registration Holder, but there are strong reasons not to do so. Your PRH actually owns your device registration in Peru, so selecting an independent partner able to focus on your business without conflict-of-interest concerns is crucial.
- You may need to provide access to your device information to your PRH, and most firms would prefer not to share proprietary design data with their distributors
- Conflicts of interests may occur in the event of an incident report or recall action if DIGEMID questions how an action was handled—even as your PRH, will your distributor defend your company or itself?
- Distributors are focused primarily on sales and marketing, not regulatory affairs, and may not have the capability as your PRH to keep you up-to-date on DIGEMID regulatory changes