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

Indian MDR released an updated list of Medical Devices Testing Laboratories, hereby approving 10 additional MDTL to carry out tests for the approval of Medical Devices registered with the CDSCO.  Contact  Contact Morulaa, We are CDSCO Registration Consultants who can assist your company to register with the Indian MDR.

The CDSCO issued a notice on 01-07-2020 which indicated the use of  certain investigational therapies, in which convalescent plasma was indicated as “Off Label” in COVID-19 patients. This information is vital and more information can be found on https://www.mohfw.gov.in.

The CDSCO has released a new circular on 1st June, 2021 for the approval of COVID-19 vaccines in Restricted Use. As per this rule, the requirement for conducting Post Approval and conducting testing for every batch can be exempted if they are approved for restricted use in US FDA, EMA,

The Indian FDA (CDSCO) has given permission as per 4244(E) that if any existing Valid import License holder applies for extension, before the expiry of their existing license, due to the prevailing pandemic, the import license (Form 10) shall be valid for a period of 6 months for all purposes