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

The import of Medical Devices for Personal Use can be imported in small quantities under the following conditions –  The Medical Device forms a part of a personal baggage of the passenger and is intended for the exclusive use of such a passenger The Medical Device will be declared as

CDSCO has given extension of Indication to Baxter for its Oxiris Filter set, which is used in the treatment of critically ill Covid 19 patients. This filter is used in blood purification due to excessive inflammatory mediators present which is called Cytokine Storm. This is a life-threatening condition. During the

The CDSCO has given instructions to all States and Union Territories to enforce strict action on the Hoarding and Black-marketing of the Remdesivir Drug injections which is administered to the Covid 19 Patients. Recently shortage of the drug was reported in the States of Madhya Pradesh, Gujarat, and Maharashtra. Following

The CDSCO brought about a new amendment on 18th April, 2021 wherein all the following devices will be effective from 1st April, 2021.  All Implantable Devices CT Scan Equipment  MRI Equipment  Defibrillators  PET Equipment  Dialysis Machine  X-Ray Machine  Bone Marrow Cell Separator  All the manufacturers importing the above mentioned, need

Cardiac ailments affect more people In India as well all over the world, than any other non-communicable disease. Cardiovascular disease is the cause of death which has doubled in recent years. The Clip delivery system which is a minimally invasive Heart Valve repair device has been launched which helps to

The Indian FDA (CDSCO)has extended the time frame of Importation of Drugs with less than 60% Shelf Life by 6 months. As per the notice the earlier circulars issued on the said subject would have expired, however the CDSCO has extended this deadline up to 31st October 2021, or further