Requirements for some protocol compliance32dsf3sadf32025-04-07T23:40:40+00:00 Requirements for some protocol complianceRequirements for submission to the MINSA/RESEGISProtocol 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 CommitteeProtocolo 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