The 30-day reference lane
EMA/WHO/reference-country approvals compress evaluation to 30 calendar days — against the 60/90/120-day class ladder.
Free field guide · PDF
Peru DIGEMID Medical Device Registration2026 Field Guide
The 30-day reference lane, the local-holder rule, and the statutory class ladder — with validity and post-market duties.
- Reference lane
- 30 days
- Fee range
- $450–$650
- Certificate validity
- 5 yrs
Sourced from DIGEMID guidance and verified 2026 publications.
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What's inside
Five pages, zero fluff
Every figure in this guide traces to a named source — DIGEMID guidance and verified 2026 publications.
The local-holder rule
A local importer or distributor must hold the registration — and if the relationship ends, the registration dies with it.
Validity and duties
5-year validity, renewal within 90 days before expiry, Spanish documentation and IFU, and post-market surveillance duties.
Sources & scope
- meddeviceonline.com, Peru's growing medical device market in Latin America.
- thema-med.com, medical device registration in Peru — DIGEMID requirements.
- mddionline.com, Latin American medical device regulations.
- trade.ec.europa.eu, EU market access factsheet: Peru medical devices.
This guide is market-access intelligence, not regulatory or legal advice. DIGEMID timelines, fees, and review practice change — professional review is required before business use.
Market Access Strategy Session
Peru on your roadmap? Start with the full picture.
A Market Access Strategy Session maps your DIGEMID route — holder selection, reference-lane evidence, and renewal planning.
Professional review is required before business use.
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