By Stewart Eisenhart, Emergo Group
Medical device market regulators in Peru have set up new special permission requirements (link in Spanish) for importing medical devices that have not yet been registered for sale in the country.
According to the new rules, Peruvian medical device market authority DIGEMID will allow importation of non-registered devices intended for research projects, training or show-room purposes, or upon justified request by a healthcare provider to treat an individual patient.
Regulators will also allow importation of medical devices into Peru for quality control and testing purposes at any laboratory accredited by the National Laboratory of Quality Control Network prior to the products’ DIGEMID registration.
These steps should help clarify elements of the medical device registration process in Peru for foreign manufacturers interested in the market but unsure of how to properly proceed.
Stewart Eisenhart covers medical device regulatory affairs for Emergo Group.