By Stewart Eisenhart, Emergo Group
DIGEMID, Peru’s medical device regulatory agency, has identified more than 400 products that do not require registration as medical devices in the country.
According to the regulator, major types of medical products are not subject to registration requirements in Peru include IVD equipment, laboratory instruments and materials, hospital clothing and furniture. Examples of exempt products include breathalyser equipment, some hematology analysis tools, cytometry equipment and dissection tables.
DIGEMID plans to update its list of devices and products exempt from registration on a regular basis.
Stewart Eisenhart covers medical device regulatory affairs for Emergo Group.