Navigating the Regulatory Landscape for Medical Technology in the Delhi NCR: Key Approvals and Timelines

Effective April 1, 2020, all medical devices in India are regulated under the Drugs and Cosmetics Act, 1940, and the Medical Devices Rules, 2017. This comprehensive approach mandates specific approvals and adherence to strict timelines.

Understanding Medical Device Classification:

The first crucial step for any medical technology firm is to accurately classify their device. Medical devices are categorized into four classes (A, B, C, D) based on their risk level, with Class A being the lowest risk and Class D the highest. This classification dictates the regulatory pathway, required documentation, and the licensing authority.

• Class A (Low Risk): Examples include tongue depressors and bandages.

• Class B (Low to Moderate Risk): Such as adhesives and certain diagnostic instruments.

• Class C (Moderate to High Risk): Including pacemakers and implantable defibrillators.

• Class D (High Risk): Like heart valves.

For Class A and B devices, the State Licensing Authority (SLA) holds primary jurisdiction for manufacturing licenses, while the Central Licensing Authority (CLA), i.e., CDSCO, oversees Class C and D devices.

Key Approvals and Processes:

1. Manufacturing License (for Indian Manufacturers):

For companies looking to manufacture medical devices within the Delhi NCR, obtaining a manufacturing license is paramount. The process typically involves:

• Application Submission: Indian manufacturers of Class A and B devices apply to the SLA using Form MD-3, with the license issued as Form MD-5. For Class C and D devices, applications are made to the CLA (CDSCO) using Form MD-7, leading to a license in Form MD-9.

• Documentation: A comprehensive set of documents is required, including a cover letter, proof of location ownership, firm constitution details, quality control data, and an undertaking that the manufacturing site complies with the Fifth Schedule of the Medical Devices Rules, 2017.

• Quality Management System (QMS): Adherence to ISO 13485:2016 standards for QMS is mandatory. Manufacturing facilities may undergo audits by the licensing authority.

• Timelines: While specific timelines can vary, the process for obtaining a manufacturing license can range from several weeks to a few months, depending on the device class and the completeness of the application.

2. Import License (for Foreign Manufacturers/Importers):

For foreign manufacturers intending to import medical devices into the Delhi NCR, the process involves appointing an Indian Authorized Agent (IAA) and securing an import license.

• Indian Authorized Agent (IAA): A foreign manufacturer must appoint a local entity with a valid wholesale or manufacturing license (MD-42) to act as their representative and liaison with CDSCO.

• Application Submission: The IAA submits Form MD-14 to the CDSCO via the SUGAM portal, seeking approval to import specific medical devices. The import license is subsequently issued as Form MD-15.

• Required Documents: Critical documents include a Device Master File (DMF), Plant Master File (PMF), ISO 13485 certificate, CE Certificate or Declaration of Conformity, Free Sale Certificate (FSC) from the country of origin, and a Power of Attorney.

• Clinical Investigation (for novel devices): For investigational medical devices without a predicate or new in-vitro diagnostic medical devices, clinical investigation in India may be mandatory. However, for import licenses, it's generally not required if the device has been marketed for at least two years in major regulated markets (e.g., US, Europe, Japan, Canada, Australia) and sufficient clinical evidence is available.

• Timelines: The import license process typically takes 3 to 6 months, contingent on the device classification and the thoroughness of the submitted dossier. Notably, as of October 1, 2023, all Class A (measuring and sterile), B, C, and D medical devices require an MD-14/15 Import License. Class A non-measuring/non-sterile devices require online registration but are exempt from the import license.

Post-Market Compliance and Renewal:

Once approvals are granted, ongoing compliance is crucial. This includes maintaining proper import records, reporting adverse events, and adhering to labeling requirements. Import and manufacturing licenses typically have a validity of five years and require timely renewal.

Navigating India's medical device regulatory landscape, particularly in a dynamic region like the Delhi NCR, demands meticulous preparation and a deep understanding of the CDSCO's requirements. Partnering with experienced regulatory consultants can significantly streamline the process, ensuring compliance and accelerating market entry for innovative medical technologies that can contribute to better patient care in the region