How to register a medical device in Peru with DIGEMID (independent PRH)

Sponsors still treat Peru as “find a droguería and hope DIGEMID likes the dossier.” That sentence mixes three seats: the titular on the sanitary registration, the importer that holds a CRS / droguería license, and the commercial distributor that wins hospital tenders. Decreto Supremo N° 001-2024-SA is what lets you keep the first seat independent of the second and third.

I am Julio Martinez-Clark, CEO of bioaccess®. This page answers the market-access question — how a medical device gets onto the Peruvian market under DIGEMID (Dirección General de Medicamentos, Insumos y Drogas) — and how an independent Peru Registration Holder (PRH) keeps channel changes from becoming a new registration project. It sits next to our LATAM market-access hub, the Peru DIGEMID country page, and the Importer of Record guide. Operator guidance only. Not a quote and not legal advice.

One-sentence answer

Commercial sale in Peru requires DIGEMID sanitary registration held by a locally enabled titular, with imports flowing through a licensed droguería — and under Decreto Supremo N° 001-2024-SA an independent Peru Registration Holder can sit separate from the distributor, while additional droguerías can obtain their own CRS to import a product already registered by another titular.

Three Peru seats — write them on separate pages

Titular / PRH. The sanitary face of the device on the DIGEMID file. This is who answers for the registration and for tecnovigilancia obligations under DS 013-2014-SA (named Responsable de tecnovigilancia, DIGEMID-format incident reports, corrective actions, distribution list). If that system fails, DIGEMID can fine (published ceilings reference UIT units) and suspend or cancel the registration. A device without a live registration cannot legally stay on the market.

Importer / droguería. Licensed storage and import capacity. Additional droguerías can, under the 001-2024-SA model described on our live Peru page, obtain their own CRS to import a product already registered by another titular — which is why an independent PRH is useful and a distributor-titular is expensive to unwind.

Commercial distributor. Sales, tenders, and field relationships. This seat should not own the sanitary number if you want the option to change channel later.

If your LOI makes the first Peruvian distributor the titular “to keep it simple,” you have not simplified. You have priced a future cesión into the deal.

What belongs in the commercial dossier (operator list)

Exact DIGEMID forms move with current practice. The working stack sponsors assemble before translators start is stable:

• Device identification, intended use, and risk class as DIGEMID will see it
• Manufacturer and manufacturing sites, with quality-system evidence appropriate to class (ISO 13485 is the practical language)
• Technical file / essential-requirements evidence already used for FDA or CE, mapped to the Peruvian petition — not dumped as a zip of US folders
• Labels and IFU in Spanish for the configuration you will sell
• Independent PRH appointment and local entity documentation
• Importer / droguería CRS story that matches who will physically import — which may be more than one licensed actor over the life of the registration
• Tecnovigilancia ownership under the holder, with a named Responsable de tecnovigilancia on file

Electrical/EMC or RF homologation for wireless devices, when required, runs through Peru’s telecom authority as a separate vendor track. Do not bury that inside the DIGEMID sanitary clock.

What this file is not

• It is not a clinical-trial authorization. First-in-human and other investigational use follow a different petition set.
• It is not “the distributor will handle registration.” Under 001-2024-SA you can — and usually should — keep PRH independent of the commercial channel.
• It is not a free pass from tecnovigilancia. Holding the number without the Responsable and the DIGEMID reporting clocks is how registrations die after launch.

How bioaccess® runs the Peru holder seat

On the live market-access offer, bioaccess® acts as the neutral Peru Registration Holder through our own Peruvian entity for sanitary registration, importer-of-record coordination under the droguería pathway, sworn translations, government fees, and tecnovigilancia as holder. Pricing for the LATAM Launch Subscription is published on bioaccessla.com/market-access (USD 7,500 per year per country for the first device family; additional families at the published add-on rates). Timelines are confirmed at proposal against the current DIGEMID queue — we do not invent a statutory day-count here.

Operator checklist before you open a Peru registro folder

1. Write “titular,” “droguería/importer,” and “distributor” on three pages. Put owners and statutes on each page.
2. Decide the independent PRH before you sign an exclusive distribution LOI.
3. Confirm the configuration you will sell matches the labels and IFU you will file — not an investigational configuration from an FIH.
4. Map FDA/CE evidence to the DIGEMID petition; do not ship the US zip as the dossier.
5. Name the Responsable de tecnovigilancia and the complaint-forwarding clock from the US system into Peru before first commercial shipment.
6. Budget how a second droguería would obtain its own CRS if you add a second importer later — that is the point of 001-2024-SA.

Talk with bioaccess® when you need Peru registro held independent of the commercial channel — or when you are sequencing a Peru FIH into a later DIGEMID market file without mixing the desks.