Govt issues draft notification on amendment on sale of Medical Devices

To grant registration certificates, the state authorities have been asked to appoint licensing authorities to issue the registration certificates for the medical device seller.

772
Govt of India Gazette of India Notification
Gazette of India

Last Updated on January 6, 2024 by The Health Master

New Delhi: The Central government recently released the draft notification vide GSR 104(E) dt 09-02-2022, of the Medical Devices (Amendment) Rules, 2022, in consultation with the Drugs Technical Advisory Board.

The amendments made in the Medical Devices Rules, 2017 mandate obtaining an online registration certificate if any person/company intends to sell medical devices exclusively.

To grant registration certificates, the state authorities have been asked to appoint licensing authorities to issue the registration certificates for the medical device seller.

The registration certificate will be required to sell, stock, exhibit, offer for sale or distribute a medical device including in vitro diagnostic medical devices.

The application for online registration has to be accompanied by a fee prescribed in the second schedule, self–certificate of compliance, details of the applicant with ID proof, documentary evidence of ownership/rental occupancy of premises being used, details of competent technical staff monitoring sales activity of the medical devices, a description on other activities being carried within the said premises, and undertaking that the applicant fulfils the storage requirements to handle medical devices.

Licensing procedure for Medical devices

Latest Notifications: Medical Devices

Classifications of Medical Devices under the provisions of MDR 2017

FAQs on Medical Devices Rules, 2017   

FAQs – on Blood Pressure Monitoring Devices

Four-side seal pouch machine introduced for Pharma Companies

Dr Reddy’s Laboratories launches generic Vasopressin injection USP

Biological E seeks extension from DCGI for its vaccine shelf life

USFDA gives nod to Lupin for Arformoterol Tartrate inhalation solution

Drug recall: Red Pill Capsules recalled due to this reason

Manufacturers of these 11 drugs to incorporate newly identified ADRs in packing

Govt releases new National List of Essential AYUSH Medicines: Download

Illegal Pharmaceutical unit unearthed by FDA, Police

 First Nasal Spray for covid-19 treatment in India: 10 things to know

Latest Notifications regarding Pharmaceuticals

For informative videos by The Health Master, click on the below YouTube icon:

YouTube Icon

For informative videos on Medical Store / Pharmacy, click on the below YouTube icon:

YouTube Icon

For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:

YouTube Icon

For informative videos on consumer awareness, click on the below YouTube icon:

YouTube Icon
Telegram
WhatsApp
Facebook
LinkedIn
YouTube Icon
Google-news