Peru · Spanish · DIGEMID
DIGEMID translation, aligned to Peruvian regulatory review.
What Peru's DIGEMID expects from Spanish clinical trial and registration documentation — and how an Amavita pilot delivers a package that clears the review cycle without avoidable observaciones.
What this covers
DIGEMID in three moving parts.
What must be in Peruvian Spanish
Protocol, informed consent, investigator's brochure, safety narratives, and product information — with Peruvian medical usage and clear patient-facing language.
Certification and legalization
Legal instruments filed with DIGEMID require an official translation and, for foreign public documents, apostille under the Hague Convention or Peruvian consular legalization.
Where submissions stall
Inconsistent INN usage, ICFs that read as literal English translations, and missing appendix translations are recurring causes of DIGEMID observaciones.
What must be in Peruvian Spanish
Protocol, informed consent, investigator's brochure, safety narratives, and product information — with Peruvian medical usage and clear patient-facing language.
Certification and legalization
Legal instruments filed with DIGEMID require an official translation and, for foreign public documents, apostille under the Hague Convention or Peruvian consular legalization.
Where submissions stall
Inconsistent INN usage, ICFs that read as literal English translations, and missing appendix translations are recurring causes of DIGEMID observaciones.
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Frequently asked
DIGEMID translation, quick answers.
What language does DIGEMID require for clinical trial submissions in Peru?
DIGEMID reviews clinical trial dossiers in Spanish. Protocols, informed consent forms, investigator's brochures, safety narratives, and product information must be translated into Peruvian Spanish, with source-language documents accepted only when paired with a compliant translation.
Who is authorized to certify translations for DIGEMID?
Legal instruments and foreign public documents require an official translator and, where applicable, apostille or consular legalization. Technical documents should be prepared by qualified medical translators reviewed by clinicians familiar with Peruvian regulatory usage.
How does the Amavita pilot cover DIGEMID submissions?
A pilot scopes one Peruvian protocol or dossier, delivers an MD-reviewed Spanish package aligned to DIGEMID expectations, and includes a pre-submission QC checklist covering terminology, ICF readability, and legalization workflow.
Next step
Scope a Peru pilot this quarter.
Share your Peru protocol or registration dossier. Our team will reach out within 2 business days with a scoped pilot proposal and timeline.