Procedure for registration of Medical Devices: CDSCO

Download guidelines issued by CDSCO, How to register Medical Devices

271
Laptop computer Online

Last Updated on December 11, 2021 by The Health Master

Download guidelines issued by CDSCO for registration of Medical Devices

Steps for manufacturers / Importers for registration of Non Notified Medical Devices

Step-1-> Follow the URL https://cdscomdonline.gov.in/NewMedDev/Homepage

Step-2-> Applicant has to click on the registration link from the portal.

Step-3-> Applicant has to register with a valid Email-id and Mobile No.

Step-4->The applicants have to upload the following documents to register on the portal:-

  • Id Proof Details
  • Undertaking
  • Corporate Address Proof Details (Certificate of Incorporation)
  • Copy of Manufacturing License and the Wholesale Licenses (If not, then upload the justification for the same)

Step-5->The applicant has to verify the registration through the OTP (4 digits) received on the mobile.

Step-6->After self-verification, the applicants can login and proceed further.

Documents required for Registration of medical devices by the Manufactures:

1. Name & address of the company or firm or any other entity manufacturing the medical device along with name and address of manufacturing site of medical device.

2. Details of medical device:

Generic NameModel No.Intended UseClass of Medical deviceMaterial                of ConstructionDimensionShelf LifeSterile or Non SterileBrand Name
         
  • Certificate of compliance with respect to the ISO 13485 standard accredited by National Accreditation Board for Certification Bodies or International Accreditation Forum in respect of such medical device
  • Undertaking duly signed by the manufacturer, stating that the information furnished by the applicant is true and authentic

Documents required for Registration of Medical Devices by the Importers:

1. Name of the company or firm or any other entity importing the medical device

2. Details of medical device:

Generic NameModel No.Intended UseClass of Medical deviceMaterial    of ConstructionDimensionShelf LifeSterile or Non SterileBrand Name
         
  • Specification and standards of that medical device
  • certificate of compliance with respect to the ISO 13485 standard accredited by National Accreditation Board for Certification Bodies or International Accreditation Forum in respect of such medical device
  • Free sale certificate from the country of origin
  • Undertaking duly signed by the importer, stating that the information furnished by the applicant is true and authentic.
  • The registration of Class A, B, C & D devices has been kept voluntary for a period of 18 months w.e.f. 1st April 2020 i.e. till 30.09.2021,
  • Voluntary Registration of Class A & B devices shall be followed by Mandatory Registration for 12 months after the 18-month voluntary registration period is over, i.e. up to 30.9.2022,
  • From 01.10.2022 Class A & B devices will fall under the licensing regime.
  • Voluntary Registration of Class C & D devices shall be followed by mandatory registration for 24 months after 18 months’ The voluntary registration period is over, i.e. 01.10.2021 to 30.9.2023
  • From 01.10.2023 Class C & D devices will fall under the licensing regime.

Source: CDSCO Website

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

For informative videos on Medical Devices, click on the below YouTube icon:

YouTube Icon

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

YouTube Icon
Telegram
WhatsApp
Facebook
LinkedIn
YouTube Icon
Google-news

Enter your email address:

Delivered by FeedBurner