In a recent circular, dated 15.5.24, CDSCO has issued a reminder for license or registration retention under MDR, 2017. This reminder for license and registration certificate renewal requirements is intended for medical device manufacturers, importers, and testing labs. This blog will provide insights into the CDSCO license retention fee.

The Central Drugs Standard Control Organization (CDSCO) is the apex regulatory body for medical devices, cosmetics, and pharmaceuticals in India. The CDCSO functions under the Directorate General of Health Services, Ministry of Health & Family Welfare, Government of India. It monitors and controls medical devices in India under the purview of Medical Devices Rules (MDR) 2017. All notified medical devices to be marketed in India are regulated under MDR, 2017.

Overview of the CDSCO medical devices registration

Let us first understand how to register a medical device and obtain aCDSCO medical device license. 

1. Medical device classification: The first step in the medical device registration process is classification of the device based on CDSCO classification system.CDSCO has categorised medical devices into four classes (A, B, C, and D) depending on risk level and intend use.The medical device to be registered needs to be categorized into one of the four CDSCO classes. The registration of the device will be per the guidelines of CDSCO class to which the medical device belongs to.
2. Preparing supporting documents: Various documents are required to support the CDSCO medical devices registration application process. CDSCO has provided a comprehensive checklist of the documents required depending on the application form. The apex regulatory body requires the documents to be written in English. The documents should be arranged as per the order mentioned by CDSCO. Preparation of the supporting documents can be tedious and time consuming. With the support from the team of experts at Pharmadocx Consultants, document preparation can be a breeze. We can help you prepare and collate all the documents per CDSCO requirements.
3. CDSCO registration and medical device license application portal: The mode of application is online. SUGAM is the official portal for online application for CDSCO medical device registration and license. The application along with the necessary supporting document need to be prepared. The application and the CDSCO medical device registration fees need to be submitted online to the CDSCO portal.
4. CDSCO review: The CDSCO will review the registration application and verify the submitted supporting documents. If necessary, CDSCO may request additional clarification or information. CDSCO may raise queries that need to be responded to.
5. CDSCO inspection: For certain medical device classes, the regulatory body will inspect the medical device manufacturing facility. They will ensure the facility meets the quality and safety standards. The regulatory body will evaluate whether the medical device is safe and effective. During the review process, CDSCO will analyse all relevant data, conduct site inspections, and consult experts in the relevant field. The regulatory body officials typically carry out the inspection within 60 days from the application date.
6. CDSCO approval or rejection: If the product meets the required safety and efficacy standards, CDSCO may approve the medical device. The CDSCO registration and license will permit manufacturing or import and sale and distribution in India.

Obtaining a CDSCO registration and license for medical devices in India is a cumbersome and lengthy process. Various supporting documents and expertise in the CDSCO application process are required. The Pharmadocx Consultants team can make the medical devices registration process seamless for you. We have more than 27 years of experience in licensing and documentation for the registration of medical devices in India. Our expertise can help you easily launch and grow your medical devices business in India.

Payment of CDSCO license retention fee

CDSCO license for medical devices manufacture/import and registration certificates for QMS medical device testing labs are valid indefinitely. All licenses, Form MD-5, Form MD-6, Form MD-9, Form MD-10, and Form MD-15, are issued for an indefinite period. The validity is indefinite unless they are cancelled or suspended by the concerned authorities. However, the validity of the registration/license is subject to CDSCO license retention fee payment within five years from the date of its issue.

Recent reminder for CDSCO license retention fee payment

Recently, CDSCO has issued a reminder to manufacturers, importers, and testing labs regarding CDSCO license retention fee payment. In the recent circular dated 15^th May, 2024, CDSCO has issued a reminder for all medical devices industry stakeholders regarding the timely payment of retention fees. The fees are required to maintain the validity of the CDSCO medical device license and registration under the MDR, 2017. Failure to pay the required fees will lead to suspension or cancellation of the license and registration. Moreover, the endorsement to the licenses or certificates will also be valid till the validity of the base license or certificate.

Notably, this reminder from CDSCO further highlights the importance of paying the fees prior to completion of the 5-year period. Not paying the retention fee on time will attract fines/penalties as well as serious negative consequences. In other words, this circular has further emphasized that the validity of your license depends on the timely payment of the retention fees. To continue manufacturing/importing medical devices for sale, it is important to pay the CDSCO license retention fee.

CDSCO fee structure

Manufacturing and loan licenses:

• Class A and B: A fee of Rs 500 is required per medical device. Additionally, for the manufacturing facility a fee of Rs 5,000 per site is required.
• Class C and D: A fee of Rs 1000 is required per medical device. Additionally, for the manufacturing facility a fee of Rs 50,000 per site is required.

Notified body registration

• A fee of Rs 25,000 is required.

Import licenses

• Class A:  A fee of $50 is required per medical device. Additionally, for the manufacturing facility a fee of $1,000 per site is required.
• Class B: A fee of $1,000 is required per medical device. Additionally, for the manufacturing facility a fee of $2,000 per site is required.
• Class C and D: A fee of $1,500 is required per medical device. Additionally, for the manufacturing facility a fee of $3,000 per site is required.
• Class A and B (invitro diagnostic device): A fee of $10 is required per medical device. Additionally, for the manufacturing facility a fee of $1,000 per site is required.
• Class C and D (invitro diagnostic device): A fee of $500 is required per medical device. Additionally, for the manufacturing facility a fee of $3,000 per site is required.

Fine imposed for CDSCO license retention fee payment delay

• CDSCO registration certificates: For delay in retention fee payment, a late fee of 2% of the retention fee per month for up to 90 days is charged. The non-payment of CDSCO license retention fee will result in automatic cancellation of the registration certificate.
• CDSCO medical device license: For delay in payment, a late fee of 2% of the retention fee per month for up to 180 days is charged. The CDSCO license retention fee non-payment after the 180-days period will automatically cancel the license.

How can Pharmadocx Consultants help you obtain and retain the CDSCO medical device license and registration?

We at Pharmadocx Consultants provide various services for CDSCO medical devices registration. Our services broadly include CDSCO medical devices manufacturing license, CDSCO medical devices test license, and CDSCO medical devices import license. Our team will not only help with license application but also provide CDSCO registration document preparation assistance. Our documentation services include assistance with preparation of device and plant master files, SOPs, essential principle checklists, and risk management. We will also ensure CDSCO license retention fee payment within the stipulated deadline so that your license/registration remains valid. Send your requirements at [email protected] or call/Whatsapp on 9996859227 and we will revert.