This news article deals with the updates in the IVD regulations in India. They have come up with three drafts as follows – Draft Guidance on Post-Market Surveillance of In-vitro Diagnostic Medical Device (IVDMD) – The CDSCO has issued an article on PMS (Post Market Surveillance) of IVDs in India.

This news deals with the latest Amendment which has been published by the CDSCO. The CDSCO has released a new Amendment in the Drugs and Cosmetics Act, 1945  with Notification number S.O.877(E) published on 23rd December,2021.The Draft rules for amendment are as follows – Note: The Medical Devices Rules, 2017

The CDSCO and The Subject Expert committee has informed that COVID -19 booster dose cannot be recommended or used without clinical trials. The Serum Institute had given an application for Booster Dose of Covid-19 on December 9th, 2021 to the SII Committee. The SEC Committee has reviewed the application from

The CDSCO has published a special condition under which the permission for Import of drugs with residual shelf life less than 60% is extended until next year. Due to the COVID-19 situation, the effective date of the circular dated on 17th April 2020, 10th July 2020 and 13th April 2021

This news deals with the latest Amendments which have been published by the CDSCO. The CDSCO has released a new Amendment in the Drugs and Cosmetics Act, 1940 G.S.R 762(E).  The Government hereby makes the following amendment in the Ministry of Health and Family Welfare, number G.S.R. 577(E), dated the

The CDSCO brought about a new amendment on 3rd November, 2021 wherein all the following rules regarding CT scan equipment, All Implantable Devices, MRI equipment etc. as Drugs will be effective from 1st April, 2021. In the old notice all the manufacturers/importers must undergo the licensing process  for the above

The CDSCO has Installed computer systems in its office and laboratory to control high risk of viruses over the internet. These viruses in the computer lead to crash/delete of the official data stored in the computer system. It may also download unnecessary files on computer systems causing serious damage to

This news deals with the latest registration circular which has been published by the CDSCO. The CDSCO has released a new Amendment in the Drugs Rule, 1945  G.S.R 524(E). The amendment came into effect on 2nd August, 2021. This gazette notification would be taken into consideration in 30 days from

This news deals with the latest registration circular which has been published by the CDSCO. The CDSCO has released a new Amendment in the Drugs Rule, 1945  G.S.R 533(E). The amendment came into effect on 5th August, 2021. This gazette notification would be taken into consideration in 30 days from

NMPA Medical Device regulations has issued an online public consultation which talks about the Optimization of Medical Device Standards. In specific, they require feedback on their optimisation methods, post their review of 93 national standards and 303 industry standards, as well as 62 existing standard formulation and revision projects. This