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Thursday, February 02, 2017

Medical Devices Rules, 2017.

Some aspects relevant to innovators:
   1. Government will be appointing medical Device Testing Officers.
(1) The Central Government may designate a Government Analyst appointed under section 20 of the Act as Medical Device Testing Officer.
(2) The Central Government or, as the case may be, the State Government, may designate an Inspector appointed under section 21 of the Act as Medical Device Officer.  
2. Government to establish Medical Device Testing Laboratory.
(1) The Central Government may, by notification, establish Central medical devices testing laboratory for the purpose of,(a)testing and evaluation of medical devices; or (b)functioning as an appellate laboratory; or(c)to carry out any other function as may be specifically assigned to it.
(2) Without prejudice to sub-rule (1), the Central Government may also designate any laboratory having facility for carrying out test and evaluation of medical devices as central medical devices testing laboratory .
3. Application for registration of medical device testing laboratory:
(1) An application for grant of registration of a medical device testing laboratory to carry out
testing or evaluation of a medical device on behalf of a manufacturer shall be made to the Central Licensing Authority through online portal of the Central Government in Form MD-39 accompanied with a fee as specified in the Second Schedule along with the information specified in sub-rule (2).        


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