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Introduction:
The CDSCO recently extended the deadline by six months for manufacturers and importers dealing with non-notified Class C and Class D medical devices. Originally scheduled for mandatory licensing from October 1, 2023, this extension aims to facilitate a smoother transition. Let’s explore the CDSCO circular and the approval procedures for these devices.
Addressing Industry Concerns:
The CDSCO’s Circular Objective
In response to concerns within the medical industry regarding the shift to a fully licensed regime, the CDSCO granted a six-month grace period to manufacturers and importers. Acknowledging worries about potential device shortages, the CDSCO extended the mandatory licensing timeline for those who applied for licenses on or before September 30, 2023, allowing them to continue operations for an additional six months.
Understanding the Licensing Process:
Registration and Licensing for Class C and D Medical Devices
The CDSCO, as the central authority, handles import and manufacturing licenses for medical devices. The process involves registering on the Sugam portal, paying fees, and submitting online applications along with necessary documentation.
Import Licensing Procedure:
1. Register on the Sugam portal.
2. Pay fees.
3. Submit Form-14 with required documents.
4. CDSCO issues Form-15 upon approval.
Manufacturing Licensing Procedure:
1. Register on the Sugam portal.
2. Pay fees.
3. Submit Form MD-7 (or MD-8 for loan licenses) with documentation.
4. Undergo a facility audit.
5. Receive Form 9 (or MD-10 for loan licenses) upon compliance.
Conclusion:
The CDSCO’s extension aims to prevent disruptions in medical device manufacturing and import. It facilitates a smoother transition to the new approval regime.
RSI’s Assistance in Navigating Regulatory Landscape:
Regulatory Solutions India (RSI) offers support to those yet to apply for Class C & D devices. With expertise in medical device regulatory affairs, RSI has aided over 450+ device registrations across various categories and countries. Services include CDSCO Medical Device Registration, Import Licensing, Wholesale/Distributor Licensing, Post Approval Changes, and Medical Device Label Compliance Review.
FAQs:
1. Eligibility for the 6-Month Extension:
Applies to manufacturers and importers who applied for licenses before September 30, 2023, allowing operations until April 1, 2024.
2. Role of Form-14:
Essential for obtaining an import license, requiring necessary documents alongside the application on the Sugam portal.
3. Understanding Form-15 in Import Licensing:
Issued upon CDSCO’s approval of Form-14, allowing importation into India.
4. Significance of Form-7 in Manufacturing Licensing:
Essential for acquiring a manufacturing license for medical devices in India.
5. Role of Form-9 in Manufacturing Process:
Signifies permission for manufacturing Class C & D medical devices upon compliance and satisfactory inspection.
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