Peru Medical Device Regulations

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

Major Regulations


Document	Language	Number	Published
Articles for the Regulation for Registration, Health Surveillance and Control of Pharmaceuticals, Medical Devices and Health Products	es	Nº 016-2013-SA	12/2013
Medical Device Regulations	es	Law No. 29459	11/2009
Regulations for the Registration, Health Surveillance and Control of Pharmaceuticals, Medical Devices and Health Products	es	No.001-2012-SA	01/2012

Specific Guidance Documents


Document	Language	Number	Published
NR1 - Diversos - Products not subject to sanitary registration, according to intended use	es	PE-001	08/2013
NR2 - In Vitro - IVDs not subject to sanitary registration	es	PE-002	08/2013
NR3 - Laboratorio - Laboratory Instruments and Material not subject to sanitary registration	es	PE-003	08/2013
NR4 - Vestuario - Hospital Clothing not subject to sanitary registration	es	PE-004	08/2013
NR5 - Mobiliario - Furniture not subject to sanitary registration	es	PE-005	08/2013

Additional Information


Document	Language	Number	Published
Medical Device Classification List	es	PE-006	09/2014