Post Market Clinical Follow Up
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Post Market Clinical Follow Up Read More »
Whereas a draft of certain rules further to amend the Medical Devices Rules, 2017 was published as required under sub-section (1) of section 12 and sub-section (1) of section 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940) vide notification of the Government of India in the Ministry of Health and Family Welfare (Department of Health and Family Welfare)
New notification by DCGI Read More »
The Drugs Controller General of India (DCGI) has instructed state drug regulators to take necessary action and direct all the manufacturers on how to upload their manufacturing sites and formulation data on Sugam portal which will strengthen the drug regulatory system by way of improving the transparency, accountability as well as accessibility of the drugs in the country.
State FDA’s Commanded by DCGI on Sugam Portals Update Read More »
This regulatory topic has turned out to be progressively relevant, in front of the commencement to the EU\’s new medical device and in-vitro diagnostic rules, set to produce results on May 26, 2020 and 2022, respectively.
Launch Procedure for Medical devices regulation Read More »