In-Vitro Diagnostic (IVD) Medical Devices Division, Frequently Asked Questions – released by CDSCO – Addendum No.:02, dated 13.03.2026

Update: CDSCO Releases New Addendum on IVD Medical Device Regulations

The Central Drugs Standard Control Organization (CDSCO) has issued a new addendum to its Frequently Asked Questions (FAQs) regarding the Medical Devices Rules (MDR), 2017. This document serves as a critical update for manufacturers, importers, and authorized agents navigating the regulatory landscape for In-Vitro Diagnostic (IVD) medical devices in India.

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Overview of the Addendum

• Issuing Authority: Directorate General of Health Services, Ministry of Health & Family Welfare, Government of India (CDSCO).
• Document Reference: Doc No.: CDSCO/IVD/FAQ/04/2022.
• Release Date: March 13, 2026.
• Purpose: To provide clarity on licensing, fee structures, and post-approval changes to ensure public awareness and regulatory compliance.

Key Highlights & Regulatory Updates

1. License Retention & Endorsements

• Simultaneous Submission: Applications for the retention of subsequently issued endorsements must be submitted together with the base license retention application.
• Validity: Endorsements remain valid as long as the base license has not exceeded five years from its issuance date.
• Late Fees: * Import Licenses: Retention fees can be paid up to 90 days late with a 2% per month late fee.
  • Manufacturing Licenses: Retention fees can be paid up to 180 days late with a 2% per month late fee.

2. Fee Structures & Calculations

• Site and Product Fees: For Class A and B IVD imports, firms must pay a site registration fee (approx. $1,000) plus a per-product fee ($10 per product).
• Upgrading Risk Classes: If a firm already holds a license for Class A/B and wishes to add Class C/D products, a higher site fee (approx. $3,000) and product fee ($500 per product) apply.

3. Operational Changes & Portal Management

• Change in Constitution: If a firm’s legal constitution changes, they must create new login credentials on the CDSCO portal and deactivate the old ones.
• Change in Site Name: A change in the name of the manufacturing site (without a change in constitution) does not require a fresh license but must be updated via a Post-Approval Change (PAC) application.
• Site Relocation: A change in the physical location of a domestic manufacturing site requires a mandatory QMS re-inspection and a fresh manufacturing license.

4. Application Procedures

• Product Limits: It is advised to apply for no more than 15 products in a single application to expedite approval.
• Subsequent Importers: An authorized agent can apply to import an IVD already licensed to another agent, provided the manufacturing site remains the same.
• Automated Alerts: The portal now sends up to four automated email reminders for query responses. If no response is received after the 4th reminder, the application is deemed withdrawn.

5. Specialized Classifications

• Multi-parameter Devices: Devices that combine IVD testing (like glucose monitoring) with In-vivo/Ex-vivo parameters (like ECG or Blood Pressure) are classified as Medical Devices, not IVD devices.
• Veterinary IVDs: * NOC: Required from the Department of Animal Husbandry and Dairying (DAHD) only if there is no predicate device.
  • CPE: Clinical Performance Evaluation is not required for new veterinary IVDs

To download the full document , click the link :
https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MTM5ODM=