Risk Class I: 6 to 8 months
Risk Class II and III: 9 to 12 months
The timing of registration may vary depending on many factors, such as the complexity of the medical device, completeness and quality of information about the medical device, how prompt the manufacturer is in providing any missing data for the medical device, etc.
The duration of the registration process may be shortened. Please contact us for a detailed review of the documentation for your medical device.