As of December, the procedure for registration, re-registration and major changes in the sanitary registry will be subject to change, specifically in the case of medical devices, with which article 28 of Supreme Decree N° 016-2011-SA is modified.

Thus, through the Directorate of Medical Devices and Medical Devices, the DIGEMID authorities announced that the presentation of a translated version of the clinical data and their respective conclusions, which will accompany both the risk management report, according to the specific ISO standard in force, as well as the Clinical Evaluation Report, is fully authorized.

In case you need further information or advice on the subject, OMC Pharma Medic is at your disposal. Write to us at: omago@omcpharmamedic.com or porladini@omcpharmamedic.com