DIGEMID medical device registration in Peru for FDA-cleared and CE-marked products. Independent Peru Registration Holder. Single all-inclusive annual fee.
Timelines confirmed at proposal stage
Decreto Supremo N° 001-2024-SA lets an independent Peru Registration Holder (PRH) be separate from the distributor; additional droguerías can obtain their own CRS to import a product already registered by another titular. bioaccess® acts as the neutral PRH through our own Peruvian entity.
Tecnovigilancia is not a PMS add-on. Peru’s DIGEMID registration holder must keep a named ‘Responsable de tecnovigilancia’ on file (DS 013-2014-SA) and report incidents in DIGEMID’s format with corrective actions and the full distribution list. If that system fails, DIGEMID can fine up to 10 UIT and suspend or cancel the registration. A device without a live registration cannot legally stay on the market. bioaccess® is the holder and runs that system on the USD 7,500 LATAM Launch Subscription.
Market Access Essentials / LATAM Launch Subscription: USD 7,500 per year per country for the first device family. Includes government submission fees, sworn translations, in-country titular/RH/IOR, and tecnovigilancia as holder. Additional families: USD 3,500 (low–mid, any country); USD 4,500 (Class III / high-risk Mexico); USD 5,500 (Class III / high-risk Brazil).
All-inclusive annual subscription includes government submission fees, in-country registered agent, regulatory liaison, and certified/sworn translations where required. Electrical/EMC and RF homologation for wireless devices are handled through the country’s telecom authority at vendor cost plus a 20% G&A handling fee.
Market Access hub · LATAM registration pricing · LATAM Importer of Record guide
Related: Clinical trials in Peru.