CDSCO: Timely pay retention fee to Avoid Disruption in Medical Device licenses

By staying informed and adhering to the MDR regulations, medical device companies can maintain their licenses.

May 18, 2024

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Last Updated on September 30, 2024 by The Health Master

Medical Device

The Indian medical device industry is a booming sector, and ensuring regulatory compliance is crucial for all stakeholders.

Recently, the Central Drugs Standard Control Organisation (CDSCO) issued a reminder to medical device manufacturers, importers, and notified bodies regarding the Medical Devices Rules (MDR), 2017.

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This article highlights the importance of timely payment of license retention fees to avoid license cancellation and potential disruption in product availability.

What are Medical Device Licenses and Retention Fees?

Under the MDR, 2017, various licenses and registrations are required for the manufacturing, import, and quality management of medical devices in India.

While these licenses are issued in perpetuity, they are subject to the payment of retention fees every five years.

Registration Certificates:

This includes certificates for notified bodies (who audit quality management systems) and medical device testing laboratories. The retention fee for registration is Rs 25,000.

Manufacturing and Import Licenses:

These licenses are categorized based on the class of medical device (A, B, C, or D) with varying fees.

The retention fee depends on the class of device and the number of manufacturing sites.

It ranges from Rs 5,000 to Rs 50,000 for manufacturing licenses and $1000 to $3000 for import licenses.

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Consequences of Non-Payment of Retention Fees

Failure to pay the retention fees by the due date will result in late fees and potentially license cancellation.

Late Fees:

A penalty of 2% per month is levied on the retention fee for a maximum of 180 days (for manufacturing licenses) or 90 days (for registration certificates).

License Cancellation:

Non-payment of retention fees and late fees after the stipulated grace period will lead to cancellation of the license or registration certificate.

This can significantly disrupt business operations and delay product availability in the market.

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How to Ensure Timely Renewal

Review License Validity:

Check the expiry date of your license or registration certificate and the corresponding retention fee due date.

Plan Fee Payment:

Schedule the retention fee payment well in advance to avoid missing the deadline.

Consult the CDSCO Website:

Refer to the CDSCO website for detailed information on license categories, fees, and payment procedures.

By staying informed and adhering to the MDR regulations, medical device companies can maintain their licenses and ensure smooth product distribution in the Indian market.

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