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Indian Authorization Agent for Medical Device Registration in India

Overview

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:

  •  
    Local Agent Representation in India.
  •  
      Liaison with the CDSCO.
  •  
     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

  • Who is an Indian Authorized Representative (IAA)?

       
  • 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.

  • What are the prerequisites for appointing an IAA?

       
  • 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.
  • Which class of products would require an IAA?

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

  • How do you register an IAA with the CDSCO?

       
  • The CDSCO’s online system for Medical Devices is the submission portal used to register an IAA and submit various application forms for device registration. The user must first create an account on the platform prior to submitting any application form for device registration.

    Steps for Registration:

    • Go to the CDSCO portal and click "Sign up/Register" to create an account.
    • Select “For import of medical device” from the drop-down menu under the registration purpose.
    • The entity shall submit the ID proof, undertaking document, Corporate Identification Number (CIN), contact details, Corporate Address proof details, and Manufacturing License or Wholesale License to register as a foreign manufacturer’s IAA.

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Resources

  • White Papers

    Regulation of Medical Devices and IVDs in India-Understanding CDSCO Requirements

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  • Blog

    The Role of an IAA in Importing and Distributing Medical Devices

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    Indian Medical Device Regulatory Landscape - Current Dynamics

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