Articles -Pharma & Cosmetics

Procedure for registration of Medical Devices: CDSCO

Download guidelines issued by CDSCO, How to register Medical Devices

Rakesh Dahiya

December 8, 2021

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Rakesh Dahiya

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

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.

Click for more on Medical Devices

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 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 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 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. 1^st 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

License fee structure for all licenses

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

Types of Licenses	Application Form	License on Form	Fee	Renewal / Retention fee	Late fee	Duplicate license	Fee per item
Drug Sale Licenses
Whole Sale	19	20-B & 21-B	3000/-	3000/-	2%	300/-	–
Retail sale	19	20 & 21	-do-	-do-	-do-	-do-	–
Homeopathic (WSDL)	19-B	20-D	250/-	20-E	50/-	150/-	–
Homeopathic (RSDL)	19-B	20-C	250/-	20-E	50/-	150/-	–
Sch. X (WSDL)	19-C	20-G	500/-	500/-	2%	150/-	–
Sch. X (RSDL)	19-C	20-F	500/-	500/-	2%	150/-	–
Drug Manufacturing Licenses
Manufacturing (Non- Biological)	24	25	7500/-	7500/-	2%	1000/-	300/-
Manufacturing (Biological)	27	28	7500/-	7500/-	2%	1000/-	300/-
Manufacturing Schedule X	24 F	25 F	7500/-	7500/-	2%	1000/-	300/-
License for Test / Analysis	29	30	250/-	Valid for 3 years. Renewal for 1 year	–	–	–
Loan License (Biological)	27-A	28-B	7500/-	7500/-	2%	No	300/-
Loan License (Non- Biological)	24-A	25-B	7500/-	7500/-	2%	No	300/-
LVP	27-D	28-D	7500/-	7500/-	2%	No	300/-
Cosmetics Manufacturing Licenses
Manufacturing	COS 5	COS 8	10,000/	10,000/-	2%	–	500/-
Loan License	COS 6	COS 9	10,000/	10,000	2%		500/-
Laboratory	COS 22	COS 23	1,000/-	1,000/-	2%	100/-	–
Additional Section	–	–	10,000/	–	–	–	–
Free Sale	–	–	No fee	–	–	–	–
Medical Devices Manufacturing Licenses
Medical Devices (A& B)	MD-3	MD-5	5000/-	5000/-	2%	–	500/-
Medical Devices (Loan License) (A& B)	MD-4	MD-6	5000/-	5000/-	2%	–	500/-
Medical Devices (C& D)	MD-7	MD-8	50,000/-	50,000/-	2%	–	1,000/-
Medical Devices Loan License (C& D)	MD-9	MD-10	50,000/-	50,000/-	2%	–	1,000/-
Registration of Medical Devices Laboratory	MD-39	MD-40	20,000/-	20,000/-	2%	–	–
Sale License	MD-41	MD-42	3,000/-	3,000/-	2%	–	–
Free Sale certificate			1,000/- for each category
Other Licenses
Blood Centre	27-C	28-C	7500/-	26-G	1000/-	No	300/-
Homeopathic Mfg License	24-C	25-C	300/-	26-C	100/-	50/-	50/-
Approval of Commercial testing Lab	36	37	7500/-	7500/-	2%	–	–
Repacking Non-Biological	24-B	25-B	700/-	700/-	2%	1000/-	100/-