How to obtain OBL licence under Indian MDR, 2017

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#1
Hi Guys..

We are the Indian manufacturer of 'Class C' X-Ray Diagnostic medical devices and we are also sourced some medical devices (Class B and Class C) form contract manufacturer ( from India) and sell with OWN BRAND LABELING (OBL) in Market.. Please guide which process we have to adopt and through which form we have to apply on Sugam Medical Device Portal for the license.

For OBL products Plant Master File & QMS as per Fifth Schedule of MDR 2017 to be submit or not.. in this case we have QMS and Plant master file but only for those products which we manufactured our self. For OBL case please guide..

Thank you for all your valuable inputs.
 
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Regulatory

Involved In Discussions
#2
Hi Guys..

We are the Indian manufacturer of 'Class C' X-Ray Diagnostic medical devices and we are also sourced some medical devices (Class B and Class C) form contract manufacturer ( from India) and sell with OWN BRAND LABELING (OBL) in Market.. Please guide which process we have to adopt and through which form we have to apply on Sugam Medical Device Portal for the license.

For OBL products Plant Master File & QMS as per Fifth Schedule of MDR 2017 to be submit or not.. in this case we have QMS and Plant master file but only for those products which we manufactured our self. For OBL case please guide..

Thank you for all your valuable inputs.
anyone have any idea!!!
 

Regulatory

Involved In Discussions
#3
Still not received any single guidance on my query. of anybody can help me out please do..
Hi Guys..

We are the Indian manufacturer of 'Class C' X-Ray Diagnostic medical devices and we are also out sourced some medical devices (Class B and Class C) form contract manufacturer ( from India) and sell with our OWN BRAND LABELING (OBL) in Market especially export.. Please guide which process we have to adopt and through which form we have to apply on Sugam Medical Device Portal for the license.

For OBL products Plant Master File & QMS as per Fifth Schedule of MDR 2017 to be submit or not.. in this case we have QMS and Plant master file but only for those products which we manufactured our self. For OBL case please guide..

Thank you for all your valuable inputs.
 
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