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