Manufacturers should follow the guidelines issued by the Central Drugs Standard Control Organization (CDSCO) regarding the renewal of medical device Import Licenses 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. Understanding the Medical Device Re-Registration/Renewal Process is crucial for continued compliance and market presence.
Steps Required for Renewing Import Licenses
- Preparing the documents as per the Retention Checklist
- 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.
Conclusion
In the dynamic landscape of medical device regulations in India, being 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 that the complexities of the Medical Device Re-Registration/Renewal Process are expertly handled.
