Medical Device Re-Registration/Renewal Process, CDSCO, India

Manufacturers should follow the guidelines issued by the Central Drugs Standard Control Organization (CDSCO) regarding the medical device Re-registration/Renewal process in India, issued under the Medical Device Rules of 2017 which are approaching their expiration. Given their five-year validity term, adherence to these guidelines is essential for maintaining market access in India.

Steps Required for Renewing Import Licenses

1. Preparing the documents as per the Retention Checklist
2. Retention Fees to be paid to the CDSCO

Manufacturers are required to pay retention fees every five years to retain market access in India. These fees, which apply to each Import License for manufacturing sites and each product, range from $50 for Class A devices to $3,000 for Class D devices, as specified in the Second Schedule of MDR 2017. This table provides specific fees applicable to each Import License for manufacturing sites and each product endorsement. Any late fees payment incurs a late fee.

Medical Devices Fee Structure

Classification Type	Manufacturing Site Fee (USD)	Device File Fee (USD)
Class A Medical Device	1,000	50
Class B Medical Device	2,000	1,000
Class C Medical Device	3,000	1,500
Class D Medical Device	3,000	1,500

In-Vitro Diagnostics (IVD) Fee Structure

Classification Type	Manufacturing Site Fee (USD)	Device File Fee (USD)
Class A In-Vitro Diagnostic	1,000	50
Class B In-Vitro Diagnostic	1,000	50
Class C In-Vitro Diagnostic	3,000	500
Class D In-Vitro Diagnostic	3,000	500

Documentation Requirements for License Renewal

The necessary documents for renewal include application forms, current licenses, detailed sales data, post-market surveillance reports, and a valid ISO 13485 certificate. It’s important for manufacturers to ensure all documentation reflects the current status and complies with CDSCO requirements. Late submissions can lead to additional fees and potentially affect their imports into the country. Please find below a checklist of documents needed for retention:

S.NO	Checklist Name	Is Mandatory
1.0	Covering letter with purpose of application	Yes
2.0	Undertaking duly signed and stamped with designation from manufacturer that there is no change in the Constitution of the Firm	Yes
3.0	Duly signed Undertaking and stamped with designation from manufacturer stating that there is no change in Plant Master File & Device Master File	Yes
4.0	Qualifications, experience, and duties of the existing skilled technical personnel	Yes
5.0	Post Marketing Surveillance data (Details of Sales, complaints, Recall, CAPA if any)	Yes
6.0	Any other additional documents	Yes
7.0	Copy of existing manufacturing license (MD-5/MD-6/MD-9/MD-10) for which retention is applied	Yes
8.0	Post Approval Change Applications (If Any)	No
9.0	Retention Fee Challan along with late fees (if any)	Yes
10.0	Duly Signed Retention Form	Yes

The renewal process does not allow any changes made to the product to be added. During the renewal process, the manufacturer is required to submit a declaration that no changes have been made to the product and manufacturing process. In order to get the renewal process with ease, any changes made to the product in the 5 years should be informed to the CDSCO making the renewal easier.

Ensuring Compliance with MD-14 Standards

MD-14 standards are essential for maintaining the quality and safety of medical devices in India. Compliance with these standards is necessary for the registration and market approval of medical devices. Morulaa assists companies in understanding and adhering to MD-14 standards, ensuring that all necessary documentation is prepared and submitted correctly. This includes detailed guidance on labeling requirements and regulatory compliance.

Navigating the SUGAM Portal for Registration

The SUGAM portal is an integral tool for the registration of medical devices in India. It streamlines the application process, making it easier for manufacturers to submit and track their applications. Morulaa provides comprehensive support for navigating the SUGAM portal, ensuring that all submissions are accurate and complete.

Conclusion

In the dynamic landscape of medical device regulations in India, staying updated on the latest CDSCO guidelines is crucial for maintaining market access. As you navigate the Medical Device Re-Registration/Renewal Process, strict compliance is essential to ensure your sales remain uninterrupted. With our extensive expertise in managing the intricate documentation required for renewing Import Licenses, Morulaa ensures that your submissions are not only comprehensive and timely but also meticulously aligned with the most current regulatory standards. By partnering with Morulaa, manufacturers can concentrate on their primary business objectives, confident in their compliance with all regulatory requirements. Contact Morulaa for expert guidance on all types of medical device registration, including handling post-approval changes, compliance with MD-14 standards, and utilizing the SUGAM portal for regulatory submissions.