Requirements for some protocol compliance

Requirements for submission to the MINSA/RESEGIS

Protocol

Informed Consent

No objection letter from research site

Sponsorship commitment letter

Certificate of good manufacturing practices for the device or related

Requirements for submission to the Ethics Committee

Protocolo en español e inglés

Informed consent

Spanish and English researcher's manual

Instructions for Use in Spanish and English

Questionnaires for subjects if applicable

Translation certificate of all documents

Insurance policy