India Authorized Representative

India AR – Authorized Agent An “Authorized agent” means a person including any firm or organisation who has been appointed by an overseas manufacturer through a power of attorney to undertake import of medical device in India. Obligations • Import and Distribution

1. Serve as the primary importer of record for the medical device, managing the import process and ensuring compliance with customs regulations.
2. Supervise the distribution of the device within India, collaborating with potential distributors or retailers.

1. Submit comprehensive registration documentation for the medical device to the Central Licensing Authority (CLA) on behalf of the foreign manufacturer, including technical documentation, free sale certificate, and labeling.
2. Act as the key contact point for the CLA and other regulatory bodies regarding the medical device in India, addressing inquiries or concerns promptly.
3. Maintain a valid wholesale license to facilitate the sale and distribution of medical devices.

1. Monitor and report any serious adverse events (SAEs) associated with the device to both the manufacturer and the CDSCO (Central Drugs Standard Control Organization).
2. Collaborate with the manufacturer and regulatory authorities in executing recalls or corrective actions related to the device.

1. Ensure strict adherence to specified storage conditions for the device throughout the distribution network in India.
2. Maintain detailed records of all imported devices, including comprehensive sale and distribution information.
3. Possess a legally binding Power of Attorney from the manufacturer, authorizing representation on their behalf.