New portal for medical device registration in India

The Central Drugs Standard Control Organization (CDSCO), the regulatory authority for medical devices in India, has launched a new online portal for the registration and regulation of medical devices in the country. The portal is part of the government’s ongoing efforts to streamline the medical device regulatory process and improve transparency and efficiency in the industry.

Here are the key details regarding the new portal and its features:

1. Medical Device Registration Portal:

The new portal, launched by the CDSCO, is aimed at simplifying the registration process for medical devices and in-vitro diagnostic devices (IVDs) in India. The portal is part of India’s move to regulate medical devices more effectively under the Medical Device Rules, 2017 (MDR).

2. Key Features of the Portal:

• Online Registration: The portal allows manufacturers and importers to register their medical devices and IVDs online, eliminating the need for manual submission of documents.
• Tracking: The portal enables tracking of the application status in real-time, allowing applicants to monitor the progress of their registration.
• Easier Access: It simplifies the process of obtaining licenses for manufacturing, import, or sale of medical devices in India, which is especially useful for domestic manufacturers and importers.
• Single Window for Multiple Activities: The portal supports a range of activities such as device registration, licensing, renewal, and modifications. It integrates different services to reduce paperwork and processing time.
• E-Tracking and Transparency: The portal includes provisions for e-tracking, which provides real-time status updates to users, ensuring better transparency throughout the process.
• User-Friendly Interface: The portal has a simple, intuitive interface to guide users through the entire registration process.
• Support for Multiple Device Categories: It accommodates all types of medical devices, including Class A, Class B, Class C, and Class D devices, as per their risk classification.
• Document Upload: It facilitates the uploading of required documents for regulatory approval, including clinical trial data, quality certificates, and risk assessments.

3. Registration Process on the Portal:

• Step 1: User Registration – The applicant must first register on the portal by providing their contact details and business information.
• Step 2: Device Categorization – The applicant must categorize the medical device according to its risk classification as per the Medical Device Rules.
• Step 3: Document Submission – Required documents such as the Certificate of Good Manufacturing Practices (GMP), clinical trials, and product details are uploaded.
• Step 4: Fee Payment – A payment is made for the registration fee, which varies based on the type of device and its classification.
• Step 5: Approval/License Issuance – Once the documents are reviewed and approved, the license is granted, and the applicant is notified through the portal.
• Step 6: Renewal – The portal also facilitates the renewal of licenses and registrations, making it easier to maintain compliance.

4. Key Benefits of the New Portal:

• Streamlined Regulatory Process: The portal automates much of the regulatory process, reducing delays and errors in the approval process.
• Faster Approvals: By digitizing the application and review process, the new portal significantly reduces the time taken for device approval, which is especially critical for high-demand devices such as diagnostic tools, ventilators, and critical care equipment.
• Improved Transparency: The portal offers a transparent approach by allowing applicants to track the status of their applications in real time.
• Global Competitiveness: With an easier and more predictable regulatory environment, Indian manufacturers can more efficiently bring their products to market, both domestically and internationally.
• Cost-Effective: The digitization of the registration process reduces paperwork, and minimizes the need for physical visits to the CDSCO office, leading to lower operational costs for both manufacturers and regulatory bodies.

5. Legal and Regulatory Framework:

• Medical Device Rules, 2017: The portal is designed in line with the Medical Device Rules, 2017 that regulate the manufacture, import, and sale of medical devices and IVDs in India.
• Classifications: Medical devices are classified into four categories (Class A, B, C, and D) based on their risk level. The registration process and requirements differ depending on the classification.
• Compliance with International Standards: Devices that are approved through the portal must comply with Indian standards (IS), International standards (ISO), and Good Manufacturing Practices (GMP) guidelines.
• Certificate of Registration: Once the process is complete, manufacturers and importers are granted a Certificate of Registration or a License to Manufacture for their products, depending on their category.

6. Implementation Timeline:

The new portal for medical device registration was launched in phases, and the full implementation of the registration system is expected to cover all medical device categories over time. The system has been actively used by manufacturers and importers since its launch.

7. Future Enhancements:

• Integration with Other Government Services: Future updates to the portal are expected to integrate it with other government initiatives such as the National Digital Health Mission (NDHM), and enhance its capabilities to facilitate medical device traceability and post-market surveillance.

Simplification of Processes: The portal will continue to evolve, with the goal of further simplifying the application process and ensuring that regulatory standards remain in line with international best practices.