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

In the Medical Device Rules of 2017, in Rule 7, after the words “the International Electro Technical Commission (IEC),” the following words shall be inserted “ or American Standard Test Method (ASTM)” . This rule came into effect on 5th February 2021, New Delhi How can Morulaa Help? Morulaa HealthTech

Medical devices which are non notified such as condoms, surgical dressing, sutures, umbilical tapes, etc are regulated as “Drugs” which comes under Drugs and Cosmetics Act and Rules. These medical devices require the Registration Certificate in Form 41 and also, Import License in Form 10 to import to India. However,

The medical device security is contemplated to have risen with a CAGR of around 7% to 9% since last year and might continue to grow for another 3 to 4 years. The advancement and further growth of the medical device security market look propitious in the near future with a

The CDSCO has bought in a new notification for manufacturers. Due to the expiry of several import licenses and application of extension for import licenses by pharmaceutical companies, the CDSCO introduced a new rule wherein if the applicant applies for a fresh license before the expiry of the existing license,