Must see! Full interpretation of registration duration for Class II and III medical devices

Registration cycle of Class II medical devices:

1. Without clinical trials:
If the product is fortunately exempt from clinical trials, the registration cycle is approximately 6 to 8 months. This is simply “at light speed”, enabling the product to enter the market more quickly.

2. Including clinical trials:
If clinical trials are required, the registration cycle is approximately 10 – 12 months.From product project initiation to the completion of testing, it probably takes 4 to 7 months, which is like the pre – preparation for a marathon.

Registration cycle of Class III medical devices:

1. Without clinical trials:

In the case of exemption from clinical trials, the registration cycle is approximately 9 – 10 months. Although it is a bit longer than that of Class II products, compared with the situation involving clinical trials, it is already quite “friendly”.

2. Including clinical trials:

Once clinical trials are required, the registration cycle is extended to 12 – 18 months.

It is estimated that it will take 4 – 7 months from product project initiation to completion of testing. The clinical trial also takes 6 – 12 months, and the entire process of application for registration also takes 8 months (about 158 working days).