Peru Medical Device Regulations

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

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