The Ministry of health and family welfare in its notification dated 13th September 2019 has amended the Medical Device Rules, 2017 by bringing out the Medical device fourth amendment rules 2019.
The following amendment in the Medical Devices Rules, 2017 is as under:
In the parent rule under the Appendix, In form MD-10 which is related to loan license to manufacture for sale or distribution of Class c (Moderate High Risk Devices) or Class D (High Risk Devices) medical device for the words “state licensing authority“ the words :Central Licensing authority” has been substituted
Therefore through this amendment “the central licensing authority” shall be the signatory for form MD-10 which shall be in effect from September 13, 2019.
Click here to read the notification
