Peru Medical Device Regulations

All Peruvian medical device regulations listed below are in PDF format.

Major Regulations

DocumentLanguageNumberPublished
Articles for the Regulation for Registration, Health Surveillance and Control of Pharmaceuticals, Medical Devices and Health Productses Nº 016-2013-SA12/2013
Medical Device Regulations es Law No. 2945911/2009
Regulations for the Registration, Health Surveillance and Control of Pharmaceuticals, Medical Devices and Health Productses No.001-2012-SA01/2012

Specific Guidance Documents

DocumentLanguageNumberPublished
NR1 - Diversos - Products not subject to sanitary registration, according to intended usees PE-00108/2013
NR2 - In Vitro - IVDs not subject to sanitary registrationes PE-00208/2013
NR3 - Laboratorio - Laboratory Instruments and Material not subject to sanitary registration es PE-00308/2013
NR4 - Vestuario - Hospital Clothing not subject to sanitary registrationes PE-00408/2013
NR5 - Mobiliario - Furniture not subject to sanitary registrationes PE-00508/2013

Additional Information

DocumentLanguageNumberPublished
Medical Device Classification List es PE-00609/2014