All Peruvian medical device regulations listed below are in PDF format.
| 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 |
| 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 |
| Document | Language | Number | Published |
|---|---|---|---|
| Medical Device Classification List | es | PE-006 | 09/2014 |
Since the publication of ISO 13485:2016, risk management is a major concern for maintaining regulatory compliance in major medical device markets.
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