Frequently Asked Questions
What is the timeline for India’s medical device registration process?
It takes approximately 6-9 months to complete the medical device registration process in India, if a Technical Presentation or MDAC review is not required. A Technical Presentation or MDAC review will extend the timeframe by approximately 3-6 months. Once granted, medical device registrations in India are valid for 3 years.
Only certain products require registration in India, and most of these products are outlined in the official List of Notified Medical Devices.
It's important to note that there are some additional products that do not appear on the official list, but do require registration. For example, dental implants and hernia mesh are not identified in the List of Notified Medical Devices. However, the CDSCO’s Medical Device Division page lists them as examples of products that require registration: http://cdsco.nic.in/Medical_div/medical_device_division.htm.
If there is doubt regarding whether a device requires registration or not, Emergo can assist in soliciting the CDSCO’s feedback on this matter.