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: 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.
- TIMEFRAME: The approval process takes about 4-5 months depending on DIGEMID's processing time after we submit your regulatory dossier package for approval.
- VALIDITY: 5 years.
- AUTHORIZED REPRESENTATIVE: A local authorized representative (AR) is required to register medical devices in Peru. Your distributor or a local registration holder must be your AR.
- COST (USD):
- Professional/consulting fees: 5,599
- DIGEMID official fee: 450 to 650
- Translations: 0.25 per word in Spanish
- 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 DIGEMID. We will compile your technical and legal file, will review all labeling for compliance, and will provide post-submission assistance with DIGEMID all the way through the approval of the device registration.
This offering includes,
Unlimited regulatory and business strategy sessions with you.
Review of technical and legal documentation, gap analysis and classification of your product.
- Review of your proposed labeling and Instructions for Use materials in Spanish.
- Providing guidance on clinical data and test results if necessary.
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 DIGEMID.
- Providing your device information and documentation to DIGEMID for review and approval.
Answering post-submission follow-up questions from the DIGEMID reviewer.
Medical Device Registration Holder in Peru
Foreign manufacturers wanting to sell 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.
One of our Peruvian affiliates can act as your PRH if you would like to maintain total control of the registration of your product in Peru —as opposed to letting your distributor hold the registration under its company name. We will provide pricing upon request.
Some medical device manufacturers choose to appoint their distributor as their Peru PRH, but there are strong reasons not to do so. Your PRH actually owns your device registration in Peru, so selecting an independent entityr 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 foreign manufacturers 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.
Pricing: Available upon request.
- Price is for one (1) medical device product or family of closely related products that can be included in one single registration certificate.
- 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:
DIGEMID 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. We 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.
- Read our Terms and Conditions.