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.

Passarini Group assist you in evaluating the Peruvian medical device regulatory framework as it applies to your device(s).

See below some of the services we can offer you for the Peruvian market:

Regulatory support is provided to companies wishing to enter the Peruvian market. Regulatory assistance includes everything from the best alternative for registering your product, monitoring the registration process to clear up doubts from the regulatory body, to obtaining the registration.

After obtaining the sanitary registration, we support you in validating that the distributors with whom you make commercial agreements have the authorizations to market products in Peru. We support distributors to obtain authorization to market your products.

Sanitary techno-surveillance of products already registered in Peru.

Holding service helps manufacturers and distributors to enter the Peruvian market more quickly, without the need to sign exclusive commercial agreements with distributors, thus allowing the manufacturer to enter various potential distributors, expanding its market.

We provide regulatory support for your projects from the entry of new products, amendments to already registered products and renewal of registrations, review of labels for compliance with Peruvian legislation.

Preparation of documents for bids before public entities.

Implementation of risk management report for products to be registered.

Market studies are provided to companies, with valuable information such as a list of current competitors in the Peruvian market, a list of possible distributors according to the type of product they wish to sell, average purchases by the Peruvian state in previous years of similar or related products.

View our full DIGEMID process flow below

Passarini Group is a company that has the best specialists in Regulatory Consulting for Medical Products, applying the One Stop Shop concept daily in your company with practical solutions.

Please contact us for more information about our Regulatory Strategy Report for Peru.