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The scope of this guideline is for ventilators that are supporting or sustaining life used in ICU or during transport in medical institutions. The patients include adults, pediatrics, and neonates. It covers requirements for clinical trial as well as the requirements for clinical literature/data study from equivalent or similar life sustaining ventilators.
Based on this draft guideline, invasive ventilators need clinical trial in the future. Specifically, if your invasive ventilator belongs to one of the two categories, you should consider clinical trial.
1. The applicant is a new applicant. For instance, the manufacture has never had an invasive ventilator approved for China market.
2. The device that needs registration is a brand new product from the manufacturer, or the device has brand new clinical functions.
Whether a device should be going through the path of Clinical evaluation or clinical trial has generated so much frustration with the manufacturers as well as reviewers since the general CE/CS decrees were introduced in the past couple of years. The decrees were too general to be able to act on initially. Especially before the new CE/CS decrees were implemented, most devices, class II types and some class III, can get approval with their home country studies and or a very basic clinical evaluation report of a few pages. The series of clinical guidelines specific to the specific product category like this invasive ventilator draft guideline will provide more clarity and details to reduce confusion.
Grace Fu Palma