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. In a recent circular, 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.

CDSCO license retention fee payment reminder

Recently, CDSCO has issued a reminder to manufacturers, importers, and testing labs regarding CDSCO license retention fee payment. In a recent circular, 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, timely CDSCO license retention fee payment is important.

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 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 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 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 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 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 the 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 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.

We at Pharmadocx Consultants will help you pay your license retention fee within the stipulated deadline. For timely CDSCO license retention fee payment, drop an email at [email protected] or call/Whatsapp on 9996859227.