CDSCO Reminds Medical Device Cos to Complete Retention Fee to Keep Licenses Valid

This reminder aims to prevent the cancellation of approvals for manufacturing, importation, and quality management of medical devices.

The Central Drugs Standard Control Organisation (CDSCO) has reminded all medical device sector stakeholders to ensure timely payment of license retention fees and registration certificates under the Medical Devices Rules (MDR), 2017. 

This reminder aims to prevent the cancellation of approvals for manufacturing, importation, and quality management of medical devices.

In a recent circular, CDSCO emphasized that licenses for manufacturing or importing medical devices and registration certificates for quality management system (QMS) audits by notified bodies and for medical device testing laboratories are issued perpetually. 

However, they remain valid only if the requisite fee is paid within the stipulated timeline of the MDR, 2017. Failure to pay these fees on time will result in the suspension or cancellation of the licenses or certificates, according to CDSCO.

"The endorsement to the licenses and certificates will also be valid only up to the validity of the base license or certificate. If the fee is not deposited on time, the license or certificate shall be deemed canceled," the CDSCO stated in its communication.

Fee Structure & Penalties

According to the MDR 2017, registration certificates must be renewed every five years with a retention fee specified in the Second Schedule. 

If a certificate holder fails to pay the required fee by the due date, they must pay a late fee of 2% of the retention fee per month, up to ninety days. Beyond this period, non-payment results in the automatic cancellation of the certificate.

Licenses issued under Form MD-5, Form MD-6, Form MD-9, or Form MD-10 will also remain valid perpetually, provided the license retention fee is paid every five years. 

If this fee is not paid by the due date, a late fee of 2% per month applies for up to 180 days. Non-payment beyond this period leads to automatic cancellation.

Specific Fees for Different Categories

The fee for registering a notified body and its retention is INR 25,000. The fee for manufacturing or loan licenses to manufacture Class A and Class B medical devices is INR 5,000 for one site and INR 500 for each distinct medical device. 

Furthermore, the fee for Class C and Class D devices is INR 50,000 for one site and INR 1,000 per distinct device. The retention fee varies accordingly, with INR 5,000 per site for Class A or B devices and INR 50,000 for Class C or D devices.

Moreover, the fee for import licenses varies based on the class and type of device. 

For instance, importing Class A medical devices costs $1,000 for one site and $50 per distinct device, while Class B devices cost $2,000 for one site and $1,000 per device. 

Class C or D devices have higher fees, with import licenses costing $3,000 for one site and $1,500 per device. Retention fees for import licenses also vary from $1,000 to $3,000, depending on the class of devices.

The CDSCO has urged all stakeholders, including industry associations and notified bodies, to ensure compliance with these regulations. 

"Given the above, all stakeholders are requested to ensure that the requisite fee is deposited in the appropriate government account well before the stipulated timeline under MDR, 2017, and submit the application to the Licensing Authority to maintain the continuity of the product in the market," the CDSCO noted in its circular.

The directive aims to streamline the process of maintaining valid licenses and certificates for medical device manufacturers and importers, ensuring the uninterrupted availability of medical devices in the market.