CDSCO's Crucial Reminder to Medical Device Companies

The Central Drugs Standard Control Organisation (CDSCO) has issued a critical reminder to all stakeholders in the medical devices sector: ensure timely payment of retention fees to maintain licenses and registration certificates under the Medical Devices Rules (MDR), 2017. Failure to comply could result in the suspension or cancellation of approvals.

Perpetual Licenses Require Timely Payments

Although licenses for manufacturing or importing medical devices and registration certificates for Quality Management System (QMS) audits and Medical Devices Testing Laboratories are issued indefinitely, they hinge on the punctual payment of requisite fees. Missing these deadlines can lead to the suspension or cancellation of these licenses.

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Endorsement Validity Linked to Base License

Endorsements on licenses and certificates are valid only as long as the base license is active. If stakeholders fail to pay the necessary fees within the stipulated timeline, the associated licenses or certificates will be deemed cancelled.

MDR, 2017 Guidelines on Fee Payments

Registration Certificates: Valid indefinitely with a retention fee every five years.
Late Fees: 2% of the retention fee per month for up to 90 days; non-payment results in automatic cancellation.
Notified Bodies: May charge fees as determined by the Central Government for their services.
Licenses: Valid indefinitely with a retention fee every five years; late fees apply similarly, leading to cancellation after 180 days of non-payment.

Detailed Fee Structure

Notified Body Registration: Rs 25,000.
Manufacturing Licenses:
- Class A and B: Rs 5,000 per site; Rs 500 per device.
- Class C and D: Rs 50,000 per site; Rs 1,000 per device.
Import Licenses:
- Class A (non-IVD): $1,000 per site; $50 per device.
- Class B (non-IVD): $2,000 per site; $1,000 per device.
- Class A/B (IVD): $1,000 per site; $10 per device.
- Class C/D (non-IVD): $3,000 per site; $1,500 per device.
- Class C/D (IVD): $3,000 per site; $500 per device.

Conclusion:

To avoid the risk of suspension or cancellation, medical device firms must adhere to the CDSCO’s guidelines and ensure timely payment of retention fees.

Ensure Compliance with Operon Strategist

Is your medical device company ready to meet CDSCO’s requirements? Operon Strategist can help you navigate the complexities of the Medical Devices Rules (MDR), 2017, ensuring timely payment of retention fees and maintaining valid licenses. Contact us for expert guidance and seamless regulatory compliance.