If you’re attending this year’s China International Medical Equipment Fair (CMEF), you could benefit greatly from applying for premarket approval beforehand. Get the ball rolling when it comes to registering your medical or in vitro diagnostic (IVD) devices, and you’ll be able to select a distributor at the event and begin selling your products sooner than you would if a distributor were to register them.
Below is some must-read information to help you on your way to registering your products in China. What is the name of the competent authority? The China Food and Drug Administration (CFDA)
What is the authority’s review timeframe? Depends on the risk classification. It can vary from 4 months for Class I devices, to 22 months for Class III devices.
How long is a license valid for?
Who is the license holder? The manufacturer
What is the classification system? Medical devices are divided into Classes I-III, according to risk level and amount of testing required, with Class I devices being the lowest risk and Class III devices the highest.
Other things to be aware of: - Clinical trials are required for most Class II and III devices.
- An Authorized Representative is required during the registration process.
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