Sponsors still put “Peru” on one regulatory Gantt. That is the mistake. A first-in-human (FIH) or early feasibility study (EFS) for a medical device in Peru runs on an Instituto Nacional de Salud (INS) clinical-research track. Putting the same device on the Peruvian market later runs on DIGEMID under Ley N° 29459 and its regulation Decreto Supremo N° 016-2011-SA. Those are different desks, different dossiers, and different importers of record.
If your board slide says “Peru approved,” ask which Peru. Trial authorization is not a registro sanitario. Confusing them delays first patient and later stalls commercial import.
Two authorities, two jobs
INS is the national public-health institute that reviews clinical research protocols and related ethics pathways for studies conducted in Peru. DIGEMID (Dirección General de Medicamentos, Insumos y Drogas), inside the Ministry of Health, is the sanitary authority for pharmaceutical products, medical devices, and related sanitary products on the commercial side.
For a U.S. or European MedTech team, the practical split looks like this:
- INS file: protocol, investigator brochure, informed consent, ethics committee (CEI) packet, investigational labeling, monitoring plan aligned to ISO 14155, and the import story for units that will only be used in the study.
- DIGEMID file: sanitary registration (registro sanitario) for manufacture, import, storage, distribution, and promotion of a commercial device, with a Peruvian titular who is a habilitated pharmaceutical establishment (typically a droguería), not a PI’s clinic stamp.
DIGEMID’s own FAQ is blunt on personal or “doctor import” shortcuts for devices: the ordinary commercial path is registro sanitario plus a certified establishment. Exceptional import routes exist for narrow individual-treatment cases under Ley N° 29459 and DS N° 016-2011-SA — they are not an FIH supply chain.
What FDA reviewers will ask later
If the Peru FIH is meant to support a U.S. IDE or marketing file, design the INS package so it can satisfy 21 CFR § 812.28 (acceptance of data from clinical investigations conducted outside the United States). That regulation expects GCP, independent ethics review, and a device comparable to the version you will put in front of FDA.
ISO 14155 is the device GCP bridge FDA has publicly recognized for foreign investigations. A clean INS authorization letter does not replace an inspectable trial master file. Keep device accountability, deviation logs, monitoring reports, and the CEI correspondence in one place from day one. Eligibility of foreign data is not a clearance prediction.
Import: investigational units are not the registro SKU
Commercial DIGEMID registration numbers do not clear investigational kits. Do not put a cousin SKU’s registro on the airway bill “because the PI knows customs.” Name the trial importer before ethics stamps the protocol. Map every investigational model, accessory, and spare to the INS-authorized list. Outer labels must read as investigational, with lot or serial traceability that matches the accountability log at the site.
After last patient, close investigational inventory under the trial rules. Leaving units “for the hospital” without a new sanitary path is a new regulatory event, not a courtesy.
Holder vs distributor (commercial track only)
When you later want Peruvian market access, DS N° 016-2011-SA and Ley N° 29459 put legal weight on the titular del registro sanitario. Foreign manufacturers appoint a local titular who owns the certificate, files renewals and variations, and answers DIGEMID on vigilance and advertising aligned to the authorized labeling. A distributor who only sells stock is not automatically that titular. If the titular relationship breaks, the registro does not quietly follow the freight forwarder — you re-file.
That commercial holder conversation belongs on a separate workstream from the INS FIH calendar. Running them as one “Peru regulatory” workstream is how teams discover, mid-enrollment, that nobody can import the commercial launch SKU.
One-page gate before first patient in Peru
Write these lines with owners and document IDs before you book site initiation:
- Authority map. INS for the study; DIGEMID only if a parallel commercial registro is truly in scope this year.
- CEI + INS sequence. Ethics and INS submissions with the same protocol version and the same Spanish informed-consent text.
- Investigational importer. Legal name, warehouse authorization if required, and the document that ties the shipment to the INS authorization — not a commercial registro number.
- Device list. Every unit that will sit in the site accountability log, including accessories.
- ISO 14155 file owner. Who can produce monitoring, accountability, and CEI letters within 48 hours if FDA or a notified body asks.
- Commercial holder (optional, separate). If launch is real, name the DIGEMID titular and droguería authorization — and keep that file off the FIH critical path until FPI is locked.
Where teams burn weeks
Three patterns show up repeatedly on Peru device files:
- PI as importer. Naming the investigator as the consignee because “he runs the lab.” Unless that person is the licensed trial importer under the INS authorization, customs and sanitary inspection will not treat the airway bill as study supply.
- Registro number on investigational freight. Using a commercial DIGEMID certificate for a predicate or related model to move FIH units. The investigational article is not that registered product.
- One Spanish translation for both desks. The informed-consent and brochure language for INS/CEI is not the commercial IFU DIGEMID will later lock. Mixing them creates labeling debt on both tracks.
Fix the patterns on paper before translators start. Re-translation after first patient is a protocol amendment problem, not a word-processing problem.
Practical next step
This week, split the Peru slide into two columns: INS trial and DIGEMID registro. If the same person owns both without two dossiers, two importers, and two success criteria, you do not have a Peru plan — you have a hope. bioaccess® runs FIH/EFS execution across Latin America and holds LATAM registration/IOR work as a separate market-access track; treat Peru the same way inside your own team.
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