Peru Regulatory Framework Medical Device registration

Peruvian Medical devices regulation basics

Here below are reported some of the most relevant guidance for Medical Device Registration in Peruvian market:

Major Regulations

RegulationYear
Articles for the Regulation for Registration, Health Surveillance and Control of Pharmaceuticals, Medical Devices and Health Products 2013
Medical Device Regulations 2009
Regulations for the Registration, Health Surveillance and Control of Pharmaceuticals, Medical Devices and Health Products 2012

Specific Guidance Documents

DocumentYear
NR1 – Diversos – Products not subject to sanitary registration, according to intended use 2013
NR2 – In Vitro – IVDs not subject to sanitary registration 2013
NR3 – Laboratorio – Laboratory Instruments and Material not subject to sanitary registration 2013
NR4 – Vestuario – Hospital Clothing not subject to sanitary registration 2013
NR5 – Mobiliario – Furniture not subject to sanitary registration 2013

Additonal Information

DocumentYear
Medical Device Classification List 2014

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