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. 6. Essential principles for manufacturing medical devices Medical device manufacturer shall follow the essential principles of safety and performance of medical devices as may be specified in the guidelines issued by the Ministry of Health and Family Welfare in the Central Government, from time to time keeping in view the contemporary scientific and technological knowledge and development: PROVIDED that the guidelines to be so specified shall be in conformity with the provisions of the Act and these rules.
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