PER/93
WTO/TBT
PE Peru
  • 30 - Pharmazeutische Erzeugnisse
2017-08-02
2017-05-16

Medical devices classified under Chapter 30 of the Harmonized System or Customs Tariff

Proyecto de Reglamento que establece las reglas de clasificación y los principios esenciales de seguridad y desempeño de los dispositivos médicos (Draft Regulation establishing the classification rules for and the essential principles of safety and performance of medical devices) (34 pages, in Spanish)

The aims of the notified draft Regulation are as follows:

•  to establish the rules governing the classification of medical devices by risk level, pursuant to Article 6.2 of Law No. 29459 (Law on pharmaceutical products, medical devices and sanitary products), for sanitary registration purposes;

•  to establish the essential principles of safety and performance to be respected by the manufacturers of medical devices in order to demonstrate that such products are safe and perform in accordance with the manufacturer's intended end use.