The Requirement Of Fees Clarification For Change In Address Of Authorized Agent Without A Change In The Constitution As Post-Approval Change Under MDR 2017

 

The Medical device rules were made with a clear aim for standardization and regulation of the medical devices in India. The novel rules were made in confirmation with the Global Harmonization Task Force framework and it also confirms to the chosen international practices.

All those products and devices that come under the classification criteria as per Medical Device Rules, 2017, are regulated and given a class depending on the risk factor associated with it. There also exists a taxing time for all the manufacturers of medical devices and diagnostics for adopting and aligning the medical device documentation according to the new rules.

After approval of the medical devices and products if the authorized agent wants to change the address, then it is required to follow rules as per MDR 2017 But recently several requests were obtained at the Medical Devices and Diagnostic Division of CDSCO, for removing the rule of depositing some fees if the authorized agent wants to change address without changing the constitution after approval.

After clearly examining all representations, it was observed by the officials that there is no need for fees that have been prescribed in Schedule-VI of MDR-2017 for change in address of the authorized agent.

Thus, it was notified to all concerned officials through a notification about non-requirement of fees henceforth for any changes in address of the authorized agent without a change in the constitution.

This change will ensure that applicants are now clear about non-submission of any fee. Since the change of address isn’t concerned at all with the manufacturing processes or the output of a manufacturer.

The production facility will still have to abide by the rules and regulations. Plus, an inspection will also be carried out by the respective officials to ensure proper compliance.