Peru Medical Device Regulations

Log into RAMS to download the documents listed below along with more regulations and guidances for Peru.

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Major Regulations
Document Number Published Language
Log in Modified Articles of the Regulation for the Registration, Control, and Sanitary Surveillance of Pharmaceutical Products, Medical Devices, and Sanitary Products Decree D.S.001-2012-SA
Log in Approval of Regulation for the Registration, Control, and Sanitary Surveillance of Pharmaceutical Products, Medical Devices, and Sanitary Products Decree D.S.016-2011-SA 01/2012
Log in Law of Pharmaceutical Products, Medical Devices and Health Products Law No. 29.459
Specific Guidance Documents
Document Number Published Language
Log in Decreto Supremo No. 003-2020-SA 003-2020-SA 2020
Log in TUPA 2018 2018
Log in Modifications to the Regulation for the Registration, Control and Sanitary Surveillance of Pharmaceutical Products, Medical Devices and Sanitary Products Decree No. 016-2017-SA 2017
Log in Modifications to the Regulation for the Registration, Control, and Sanitary Surveillance of Pharmaceutical Products, Medical Devices, and Sanitary Products Decree 016-2013-SA
Log in Modifications to the Regulation for the Registration, Control and Sanitary Surveillance of Pharmaceutical Products, Medical Devices and Sanitary Products Decree No. 029-2015-SA 2015
Log in MINSA Regulation of Pharmacovigilance and Technovigilance Activities for Pharmaceutical Products, Medical Devices and Sanitary Products Resolution No. 539-2016 2016 English
Additional Information
Document Number Published Language
Log in Provides for the simplification of administrative procedures by the General Directorate of Medicines, Supplies and Drugs. RM No. 668-2019-MINSA 2019