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Union of India - Section

Section 5 in The Medical Devices Rules, 2017

5. Medical device grouping.

- Any person who intends to apply for grant of licence in respect of medical devices for,-
(i)import;
(ii)manufacture for sale or for distribution; and
(iii)sale, stock, exhibit or offer for sale,
may group all or any medical device in accordance with the guidelines to be issued from time to time by the Ministry of Health and Family Welfare in the Central Government, by taking into consideration the technological changes or development in the field of medical devices and in vitro diagnostic medical devices.