Indian Authorization Agent for Medical Device Registration in India

With Indian medical device regulations undergoing significant changes, manufacturers must stay ahead of the curve. As per the Medical Device Rules (MDR) of 2017, foreign manufacturers without a local subsidiary in India are mandated to appoint an Indian Authorized Agent (IAA), a legally registered entity or person responsible for submitting registration applications on behalf of the manufacturer.

Indian Authorization Agent for Medical Device Registration in India Overview

With Indian medical device regulations undergoing significant changes, manufacturers must stay ahead of the curve. As per the Medical Device Rules (MDR) of 2017, foreign manufacturers without a local subsidiary in India are mandated to appoint an Indian Authorized Agent (IAA), a legally registered entity or person responsible for submitting registration applications on behalf of the manufacturer. Freyr addresses the common concerns surrounding the selection and appointment of an IAA, unraveling the key inquiries posed by manufacturers of medical devices and IVDs.

Freyr IAA Competencies

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    Local Agent Representation in India.
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    Liaison with the CDSCO.
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    Post-market Surveillance (PMS) Activities.
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    License Renewal.
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    Regulatory Advisor.
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    End-to-end Registration Support.
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    Submit the Import License Application.
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    Submission of Test License for Import for the Test, Evaluation, and Clinical Investigations.
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    Post-approval Changes and Endorsement Applications.
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    Obtain Prior Approval Before Implementation of any Major Changes.

Frequently Asked Questions (FAQs)

The Medical Device Rules (MDR), 2017 requires the foreign manufacturers who do not have any local subsidiary in India to appoint an IAA. The IAA is a local entity registered with the CDSCO that can submit the registration application on behalf of the foreign manufacturer and act as a bridge between the CDSCO and the foreign manufacturer.

To act as a foreign manufacturer’s IAA, the following prerequisites established by the CDSCO must be fulfilled. An IAA must:

  • Be any corporation or enterprise established in India with an active Corporate Identification Number (CIN).
  • Be a Resident of India
  • Obtain Power of Attorney (POA) from the foreign manufacturer for medical device registration with the CDSCO.
  • Have a Manufacturing or Wholesale or Distributor License under the Drugs and Cosmetics Act, 1940, and Rules 1945.

IAA is required for all risk classes of medical devices and In-Vitro Diagnostic (IVD) devices.

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Indian Authorization Agent for Medical Device Registration in India

  • Regulatory Support: Possessing an in-depth knowledge of Indian medical device regulations and developing customized regulatory strategies to ensure compliance and smooth market entry.
  •  Continuous Liaison with Agencies: Expertly managing regulatory queries and delivering precise, prompt responses to facilitate seamless approval processes.
  • Single Point of Contact: Coordinating all regulatory activities, submissions, and feedback to ensure consistent and clear communication between the manufacturer and the regulatory agency.
  • Leverage deep expertise in Indian medical device regulations.
  • customized strategies for efficient approval processes.
  • Ensure smooth and compliant market entry with comprehensive regulatory support.
  • Rely on prompt and accurate responses to regulatory queries.
  • Ensures compliance with all relevant Indian standards and regulations.
  • Minimize regulatory risks with a proactive approach.