About this document
Medical Device Classification in the Philippines by coolshava is a document available to read on EtoBox.
The document provides an introduction to medical device regulation. It explains that regulation varies by country, with the US FDA regulating medical devices in the US by classifying them into Classes I, II, and III based on risk. Class I devices have the lowest risk while Class III devices have the highest risk. The FDA oversees the registration, clearance or approval process and monitors adverse events. The document also defines what constitutes a medical device and provides examples of devices in each cl
- Author
- coolshava
- Language
- EN