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Medical Devices (……Amendment) Rules, 2021
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
Import of Non-Notified Medical Devices
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,
Medical Device Market Analysis
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
CDSCO Brings in some Relaxations!
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,
Gastrointestinal Symtoms shown in 50% of cases
Dr D.K. Bhargava, Senior Consultant, Gastroenterology & Hepatology, Indraprastha Apollo Hospital has stated that the Gastrointestinal Tract can also serve as a route for the spread of COVID-19. However, this has not been proven completely. In 20% of the cases, anorexia, diarrhea, vomiting and nausea is seen and sometimes close
Steps Taken To Ensure Supply of Remdesivir
The Indian Medical Association has put forward a complaint about the shortage of Remdesivir in Gujarat. The government was assured that the next batch of 30,800 injections would be available to them next week. This shortage was experienced as there were cases of COVID-19 reported in the manufacturing sites. Contact Morulaa
CDSCO Extends Timelines To November 1st, 2021
CDSCO Amends the Gazette Notification dated 16th October, 2019 wherein the words and figures “the 1st day of November, 2020”, the words and figures “the 1st day of November, 2021” shall be substituted. Contact Morulaa for Latest Updates in the Medical Device Sector, Market Research Surveys, Regulatory Approvals, Importation, Warehousing
North India Hoping to get Volunteers for Covaxin Trial
The Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences is hoping to get 1,000 volunteers for the Phase-3 Trials of Covaxin. 200 volunteers will be initially administered with the vaccine to understand the antibody response. The lower age limit for these trials will be 18 years, however, there
A South Indian Based Company comes up with a Device to help Patients and Healthcare Professionals
A company from Chennai, claims to have developed a device which would be useful in filling the gap between COVID-19 patients and the medical staff treating COVID patients. Every patient does not have a dedicated attendant, to help curb the spread of the virus. Company’s CEO, Vigneshwar patented “Etticos COVID-19
India Fights It’s Battle By Promoting “Make in India”
In order to help various states face the rising number of cases during this pandemic, the Central Government has distributed over 1 crore Personal Protection Equipments (PPE), more than 3 crore N95 masks to many Union Territories and States. Apart from the above mentioned, they have also distributed over 10