New DIGEMID Regulations

DIGEMID, Peru’s medical device market regulatory agency, has rolled out new disclosure and labeling rules for medical devices that contain polyvinyl chloride (PVC) or PVC that contains DEHP (di-(2-ethylhexyl)phthalate).

The new rules - http://www.digemid.minsa.gob.pe/UpLoad/UpLoaded/PDF/Comunicados/2015/C23_2015-06-03.pdf (link in Spanish) require manufacturers and Peru Registration Holders (PRH) of devices already registered with DIGEMID - https://www.emergogroup.com/services/peru/medical-device-registration-and-approval-peru to notify the regulator within 15 days of May 29, 2015, that their products include PVC or PVC with DEHP.

By March 2016, affected companies will need to include additional labeling disclosing to users that their devices contain PVC and DEHP. Registration holders of medical devices incorporating PVC but not DEHP must add “DEHP Free” statements to their labeling and/or insert materials by that same deadline.

The new DIGEMID requirements will primarily impact manufacturers, importers, and/or PRHs of devices designed to come into contact with liquids—such as bags and tubing for intravenous applications.