Procedure for registration of Medical Devices: CDSCO

Download guidelines issued by CDSCO, How to register Medical Devices

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SDCO Cum Licensing Authority |
Food and Drugs Administration, (FDA) Haryana, India. |
Email ID: dahiya19@yahoo.com
Rakesh Dahiya

Last Updated on March 19, 2023 by The Health Master

Download guidelines issued by CDSCO for the 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 the 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 log in 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 the name and address of the manufacturing site of the 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 the National Accreditation Board for Certification Bodies or International Accreditation Forum in respect of the 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.

Fee structure for all types of licenses

Download the pdf file for the license fee structure for all licenses under the Drugs and Cosmetics Act 1940 and the Rule framed thereunder. Click below link


Fees for various kinds of drugs Licenses under Drugs and Cosmetics Act 1940 & Rules 1945

Types of LicensesApplication Form License on Form FeeRenewal / Retention fee Late fee Duplicate licenseFee per item
Drug Sale Licenses
Whole Sale1920-B & 21-B3000/-  3000/-2%  300/-
Retail sale1920 & 21-do--do--do--do-
Homeopathic (WSDL)19-B20-D250/-20-E50/-150/-
Homeopathic (RSDL)19-B20-C250/-20-E50/-150/-
Sch. X (WSDL)19-C20-G500/-500/-2%  150/-
Sch. X (RSDL)19-C20-F500/-500/-2%150/-
Drug Manufacturing Licenses
Manufacturing (Non- Biological)24257500/-7500/-2%  1000/-300/-
Manufacturing (Biological)27287500/-7500/-2%  1000/-300/-
Manufacturing Schedule X24 F25 F7500/-7500/-2%1000/-300/-
License for Test / Analysis2930250/-Valid for 3 years. Renewal for 1 year
Loan License (Biological)27-A28-B7500/-7500/-2%  No300/-
Loan License (Non- Biological)24-A25-B7500/-7500/-2%  No300/-
LVP27-D28-D7500/-7500/-2%  No300/-
Cosmetics Manufacturing Licenses
ManufacturingCOS 5COS 810,000/10,000/-  2%500/-
Loan LicenseCOS 6COS 910,000/10,0002% 500/-
LaboratoryCOS 22COS 231,000/-1,000/-2%100/-
Additional Section10,000/
Free SaleNo fee
Medical Devices Manufacturing Licenses
Medical Devices (A& B)MD-3MD-55000/-5000/-2%500/-
Medical Devices (Loan License) (A& B)MD-4MD-65000/-5000/-2%500/-
Medical Devices (C& D)MD-7MD-850,000/-50,000/-2%1,000/-
Medical Devices Loan License (C& D)MD-9MD-1050,000/-50,000/-2%  1,000/-
Registration of Medical Devices LaboratoryMD-39MD-4020,000/-20,000/-2%
Sale LicenseMD-41MD-423,000/-3,000/-2%
Free Sale certificate  1,000/- for each category    
Other Licenses
Blood Centre27-C28-C7500/-26-G1000/-No300/-
Homeopathic Mfg License24-C25-C300/-26-C100/-50/-50/-
Approval of Commercial testing Lab36377500/-7500/-2%
Repacking Non-Biological24-B25-B700/-700/-2%1000/-100/-

Source: CDSCO Website

Licensing procedure for Medical devices

Latest Notifications: Medical Devices

Classifications of Medical Devices under the provisions of MDR 2017

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