Transition Time Of 6 Months To Implement New Medical Device Rules, 2017

PSM News /

Mumbai, 15 Oct 2019:

 

The Union health ministry has approved a transition time of 6 months to implement provisions of new Medical Device Rules (MDR), 2017 for the purpose of switching inventory of labelling or packaging from old  license to new license.

 

As per the approval, licenses issued or renewed for medical devices under Drugs and Cosmetics (D&C) Rules, 1945 before implementation of new MDR, 2017 can avail this benefit as according to the recent drug consultative committee (DCC) recommendation this is not practical as old inventory cannot be destroyed or wasted needlessly.

 

There is no provision in the MDR, 2017 to permit such transition period for fresh licensees. The new license number is applicable from the day it is issued by the state licensing authority (SLA).

 

DCC in its 57th meet in Goa recently considered the recommendation from the domestic industry that license issued or renewed for medical devices under D&C Rules, 1945 before implementation of MDR, 2017 is valid as per MDR, 2017.

 

DCC also recommended that for the purpose of export, in case of name change of the firm, the licensee shall obtain the permission from licensing authority to use the old name for the purpose of exhausting transition time of registration in foreign countries. Such permission will be given initially for one year and extendable for further period as per the request of applicant. DCC deliberated the matter of such transition from one old license to another new license due to change in MD Rules as the old license is still having its residual shelf life and recommended that only one license shall be operational till its expiry.

 

The license which licensee would like to continue with shall be indicated by the applicant himself. If the licensee wants to use old license till expiry, then the new license shall be made effective from the next day of expiry of the old license.

 

Association of Indian Medical Device Industry (AIMED) had also requested the Union Health Ministry to amend Rule 97 of new medical device rules, 2017 to get the transition period of 6 months approved from old license to new license for medical device manufacturers. Pharmabiz