Hi,
can anyone inform us about these new rules GSR 78 (E) , for subcontractor or job worker to a licensed medical device manufacturer in India should the contractor / jobworker also require license or an ISO 13485 certificate is good enough . we cannot find the details in the rules . Firstly we are told that the present law does not allow job worker concept but from 1/1/18 it is allowed but what is the procedure.
Can our Indian friends please help out?
Thanks
Michelle
can anyone inform us about these new rules GSR 78 (E) , for subcontractor or job worker to a licensed medical device manufacturer in India should the contractor / jobworker also require license or an ISO 13485 certificate is good enough . we cannot find the details in the rules . Firstly we are told that the present law does not allow job worker concept but from 1/1/18 it is allowed but what is the procedure.
Can our Indian friends please help out?
Thanks
Michelle