Authorized agent for medical devices oversees a foreign manufacturer’s regulatory compliance and import operations in India. This blog will guide you on how to choose an “Indian Authorized Agent” for launching your medical device in India.

Who is an Indian authorized agent for medical devices?

As per CDSCO guidelines, all manufacturers/importers planning to sell medical devices in India mandatorily need the CDSCO registration and license. Any foreign manufacturer, not having local presence in India, planning to distribute and sell medical devices in India need to appoint an Indian Authorized Agent (IAA). The agent will oversee compliance of your medical device with Indian regulations. The Indian authorized agent for medical devices acts as a liaison between foreign manufacturers and Indian regulatory authorities. The appointed agent will work on behalf of the foreign company and act as a point of contact. As stated in Medical Devices Rules, 2017, Chapter 1, any entity given a power of attorney by an international manufacturer to import medical devices into India is an “Indian authorized agent.”

Basic requirements to be a medical device authorized agent

A local entity needs to meet certain criteria before being appointed as the Indian authorized agent for medical devices.

• Must be an Indian resident
• Must possess a valid wholesale license under 20B and 21B
• Must possess an active Corporate Identification Number (CIN) and be a registered corporation or enterprise in India
• Must have a registered account in the official CDSCO online portal, SUGAM
• Must have been the legal authority to act on behalf of foreign companies and process the CDSCO registration

Responsibilities of an authorized agent for medical devices

The agent is legally responsible for the medical devices being marketed in India. The Indian authorized agent for medical devices has the following responsibilities:

• The agent will be the point of contact with the CDSCO for the foreign manufacturer.
• The medical device authorized agent will submit the application for medical device registration using the agent’s account on SUGAM portal.
• The agent will relay the application status and any query raised to the foreign manufacturer.
• The authorized agent will convey the importer’s name and address and import license number to the foreign manufacturer. This information will be included on the device label or shelf pack.
• The authorized agent for medical devices will carry out the import process at the customs port office.
• The agent will be responsible for reporting any complaints or adverse events that occur during the licensing period.
• The agent will carry out post market surveillance activities for the medical device in India
• It is the responsibility of the Indian authorized agent to ensure compliance with the regulatory requirements of the respective state licensing authority.
• The agent will be responsible for reporting any changes in the device or manufacturing facility post license issue. The agent will relay this information to the CDSCO.
• Five years post license issue, the authorized agent has to apply to the central licensing authority to renew the license. The agent will have to pay the license retention fee.  

Thus, the medical device authorized agent will assume the responsibility for the medical device in India. All applications from the foreign manufacturer must be channelled via the Indian authorized agent. It will act as the primary interface between the overseas manufacturer and CDSCO.

Why should you not appoint any importer or distributor as your Indian authorized agent?

• The primary focus of importers and distributors is marketing and sales. They may not have in-depth knowledge of the Indian regulatory requirements for medical devices.
• While preparing the necessary documents, such as the Device Master File, the design information will be inevitably revealed to the distributor or importer.
• Reporting of adverse events and product recalls may lead to conflict of interest.
• If you use an importer or distributor as your medical device authorized agent, you will be obligated to maintain the same distributor for the five-year period. With no option for registration certificate transfer, for changing your distributor, you will have to start your registration afresh.

Factors to consider while choosing your Indian authorized agent

Choosing a qualified authorized agent for medical devices is essential to enter the Indian medical device market. The agent will navigate the regulatory affairs and be your gateway to the Indian market.

• Assess the expertise of the agent in the category to which your medical device belongs to. Gauge the suitable of the agent for your unique medical device requirements.
• Verify whether they have experience with Quality Management System (QMS) compliance. This will be essential for obtaining the necessary certifications.
• Find an agent with an understanding of the Indian medical device market. The agent can provide insights into the distribution channels and potential challenges faced in India. This local physical presence will facilitate communication and compliance.
• Check the registration status of the agent with the CDSCO as an Indian authorized agent for medical devices.
• Find an agent with a proven track record and presence in the Indian medical device industry. Understand the roles and responsibilities of an agent so that you can identify one with a deep understanding of India’s regulatory landscape.
• An agent who provides timely and clear response to queries and effectively relays updates on regulatory matters is extremely valuable.
• Choose an agent who wishes to maintain a long-term relationship with your company, as regulatory requirements and compliance are ongoing.
• Gather references and recommendations from other medical device manufacturers.

Appointing an Indian authorized agent

Foreign manufacturers cannot submit an application for CDSCO registration of their medical devices in India. It is mandatory to appoint an Indian authorized agent for medical devices. The agent will work on behalf of the overseas manufacturer and submit the application to CDSCO. Points to remember while appointing a medical device authorized agent:

1. Make a comprehensive legal agreement that will clearly state the responsibilities, roles, and obligations of both the parties.
2. Have a Non-Disclosure Agreement in place with the agent. It is important that your agent respects your proprietary information and maintains confidentiality regarding your medical device.
3. Get quotations on the required costs and fees before making a deal.
4. Ensure that your agent has a clear understanding of the category and regulatory requirements of your specific medical device.
5. Ensure the agent is willing to send you regular updates on the regulatory affairs.

Pharmadocx Consultants as your Indian authorized agent

India is emerging as a global potential hub for medical devices. Foreign manufacturers planning to enter the Indian market need an Indian authorized agent for medical devices. With the CDSCO MD42 license, IEC Code, and ISO 13485 certification, we are uniquely positioned to serve as Indian authorized agents. Our expertise in CDSCO regulations for medical devices will help you launch your medical devices in India without regulatory hassle. Pharmadocx Consultants cater to overseas manufactures by handling their import requirements while ensuring compliance with the stringent CDSCO regulations. Our authorized agent service can help foreign companies easily enter the Indian medical devices market. We will help you establish a local presence in India. Let us be your trusted partner who can help you establish your business in this potential hub for medical devices. Email us at [email protected] or call/Whatsapp on 9996859227, to set in motion your Indian medical device registration journey.