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Peru Regulatory Framework Medical Device registration

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Peruvian Medical devices regulation basics.

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

Regulations

Regulation	Year
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

File	Year
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

More Info

File	Year
Medical Device Classification List	2014

Regulation	Year
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

File	Year
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

File	Year
Medical Device Classification List	2014

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