Regulatory Open Forum

Querry-

So if post approval change is major change, (in my case, the brand name of the medical device is changed and Logo of company is changed).

I know the process-

• If the change is considered a major change as specified in the Sixth Schedule of the Medical Devices Rules, 2017, the authorized agent must obtain prior approval from the CLA before implementing the change.
• The CLA will review the application and may issue directions regarding the marketing, sale, or distribution of the medical device, including any conditions that must be met for the approval of the change.
• Upon approval, the manufacturer or AR must implement the changes in compliance with the conditions set by the CLA and update all relevant labeling and marketing materials to reflect the new brand name and logo.
• Include the registration number on the label of the medical device, as required by the Medical Devices Rules, 2017.

 What is the application Form to apply for getting approval from Authority in SUGAM portal? please help me in this, as in regulations this is not mentioned.