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
- Preparing the documents according to the medical device 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. It is highly recommended to have an authorized agent assist with the re-registration renewal process.
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, which are all required for obtaining a medical device import license in India. It’s important for manufacturers to ensure all documentation reflects the current status and complies with CDSCO requirements to facilitate medical device approval in India. Late submissions can lead to additional fees and potentially affect their imports into the country. Please find below a checklist of documents required for medical device 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.
The medical device re-registration process requires manufacturers to submit all required documentation to CDSCO. Re-registration process also includes submitting updates on any changes that occurred during the product’s lifecycle. Manufacturers should pay particular attention to the deadlines outlined in the medical device re-registration guidelines to avoid delays in the renewal process. Working with an authorized agent can help ensure that all paperwork is filed promptly.
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 medical device registration and market approval. 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. Manufacturers may also need to consider MD-15 when submitting their documentation for medical device registration in India.
Navigating the SUGAM Portal for Registration
The SUGAM portal is an integral tool for medical device registration 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 and securing a medical device import license in India. As you navigate the Medical Device Re-Registration/Renewal Process, strict compliance is essential to ensure your sales remain uninterrupted and achieve medical device approval in India. 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. Medical device re-registration is an ongoing process that must be followed to maintain market approval in India. MD-14 standards may be relevant for specific medical devices during the registration process.
Contact Morulaa for expert guidance on all types of medical device registration in India, including handling post-approval changes, compliance with MD-14 standards, and utilizing the SUGAM portal for regulatory submissions.