What are the new portals for medical device registration in India?

In India, the Central Drugs Standard Control Organization (CDSCO), under the Ministry of Health and Family Welfare, is responsible for regulating medical devices, including their registration. Over recent years, the Indian government has launched and updated several portals and online systems to streamline the registration process for medical devices. These platforms aim to enhance transparency, efficiency, and compliance with regulatory standards. Some of the key portals for medical device registration in India include:

1. SUGAM Portal:

• Overview: The SUGAM portal is the primary online platform used for medical device registration in India. Launched by CDSCO, this system enables manufacturers, importers, and distributors to submit applications for registration and licenses for medical devices.
• Key Features:
  • Registration of medical devices and in-vitro diagnostic (IVD) devices.
  • Online submission of documents and applications.
  • Tracking the status of the registration application.
  • Integration with other regulatory processes, such as licensing and permissions.
  • It simplifies the process for importers, manufacturers, and distributors to get approval for selling medical devices in India.

2. eFiling Portal:

• Overview: The eFiling portal is another important platform provided by CDSCO for online registration and licensing of medical devices, particularly for manufacturers and importers.
• Key Features:
  • Allows users to submit applications for import licenses and manufacturing licenses.
  • Enables the submission of new drug applications, clinical trials, and bioequivalence studies related to medical devices.
  • Provides a central hub for regulatory filings and approvals.
  • Integration with SUGAM for device registration applications.

3. MDP (Medical Device Portal):

• Overview: As part of India’s evolving regulatory landscape for medical devices, the Medical Device Portal (MDP) is a recent initiative aimed at simplifying the registration process and improving compliance for medical device manufacturers and importers.
• Key Features:
  • Aimed at providing a centralized platform for registration and compliance monitoring of medical devices.
  • Specifically designed for the new medical device rules that came into effect in 2017.
  • Helps ensure compliance with GxP (Good x Practices), manufacturing standards, and post-market surveillance.

4. National Medical Devices Promotion Council (NMDPC) Portal:

• Overview: The NMDPC Portal is another government initiative to promote the medical devices sector in India. It primarily focuses on supporting the “Make in India” initiative for medical devices and helping domestic manufacturers.
• Key Features:
  • It provides information on the registration process for medical devices.
  • It offers guidance on government schemes, policies, and support mechanisms for medical device manufacturers.
  • It helps foster collaboration between domestic and international stakeholders in the medical device sector.

5. Online Licensing System for Manufacturing and Importing:

• Overview: This system provides an online platform specifically for the registration of medical device manufacturers and importers. It is part of the MDL (Medical Device Licensing) System under CDSCO.
• Key Features:
  • Provides facilities for the issuance of import licenses and manufacturing licenses for medical devices.
  • Facilitates the online submission of documents required for product approvals.
  • This system is intended to simplify the process and reduce manual intervention in licensing and registration.

6. Online System for Clinical Trial Approval for Medical Devices:

• Overview: This is an online platform specifically designed for clinical trials of medical devices in India.
• Key Features:
  • It enables the submission of applications for clinical trial approval for medical devices.
  • It provides a platform for regulatory bodies to review and grant approvals for trials.

Key Considerations for Medical Device Registration in India:

• Classification of Devices: India classifies medical devices into four categories based on risk (Class A, B, C, D), and the registration process may vary according to the classification.
• Approval Process: The Central Drugs Standard Control Organization (CDSCO) is the key regulatory body for medical device approval, and it has established clear processes for both domestic manufacturers and importers.
• Compliance with Indian Medical Device Rules (2017): Medical devices must comply with the Medical Device Rules, 2017, which regulate the manufacturing, import, and distribution of devices in India. These rules align India with international standards for device safety and performance.

The SUGAM Portal and other government platforms, such as eFiling and the NMDPC Portal, are central to the modernization and streamlining of medical device registration in India. These systems facilitate the easy submission of applications, tracking of approvals, and greater transparency in the regulatory process. For manufacturers and importers, these portals are essential tools to navigate the evolving medical device landscape in India.