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Food and Drugs Administration, (FDA) Haryana, India.
Email ID: [email protected]
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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 Name | Model No. | Intended Use | Class of Medical device | Material of Construction | Dimension | Shelf Life | Sterile or Non Sterile | Brand 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 Name | Model No. | Intended Use | Class of Medical device | Material of Construction | Dimension | Shelf Life | Sterile or Non Sterile | Brand 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
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