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
Under Decreto Supremo N° 016-2011-SA, as updated by Decreto Supremo N° 020-2024-SA, regulatory ownership is decoupled from commercial distribution: an independent PRH can hold the registration, and additional droguerías can pull their own CRS to import a product already registered by another titular. bioaccess® acts as the neutral PRH so control of the registration never sits with a single distributor. See the LATAM Importer of Record guide for the full country breakdown.
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 as holder under the annual holder fee.
Two-part pricing for Peru: a one-time registration fee of $4,250 (Class I), $6,500 (Class II) or $10,500 (Class III/IV), then an annual holder fee of $4,200 from year 2. The registration fee includes initial government fees and certified/sworn translations up to a stated cap, and the first 12 months of holder service; see /market-access#pricing for caps and exclusions. USD, excluding VAT and local taxes; valid for agreements signed by 31 March 2027. RF homologation is not included and is quoted separately.
Market Access hub · LATAM registration pricing · LATAM Importer of Record guide
Related: Clinical trials in Peru.