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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.
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.
Can my distributor in India act as an IAA?
- Foreign manufacturers may appoint importers or distributors as their IAA. However, it would be ideal to go for an independent IAA service provider as their authorized representative in the Indian market. Appointing an independent agency gives the manufacturer the flexibility to appoint multiple distributors and importers to realize their business expansion and market penetration goals.
Do we need to include the details of an IAA on the label?
- Yes, the medical device and IVD labels must contain information about the name and registered address of the IAA.
Can my distributor in India act as an IAA?
- Foreign manufacturers may appoint importers or distributors as their IAA. However, it would be ideal to go for an independent IAA service provider as their authorized representative in the Indian market. Appointing an independent agency gives the manufacturer the flexibility to appoint multiple distributors and importers to realize their business expansion and market penetration goals.
What are the critical steps for becoming an IAA for a manufacturer?
- Some of the critical steps to be followed by a manufacturer to become an IAA-
- Having an entity registered in India
- SUGAM account registration
- Obtaining the label of Power of Attorney (POA)
What happens if I change an IAA?
- You can change your IAA at any given point in time, and the IAA should notify the CDSCO about the termination of services. Changing an IAA requires de-registration by the old IAA followed by re-registration by the new IAA and payment of registration fees. The manufacturer must make sure to add the information of the new IAA on the label.
Can my distributor in India act as an IAA?
- Foreign manufacturers may appoint importers or distributors as their IAA. However, it would be ideal to go for an independent IAA service provider as their authorized representative in the Indian market. Appointing an independent agency gives the manufacturer the flexibility to appoint multiple distributors and importers to realize their business expansion and market penetration goals.
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.
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.
Do we need to include the details of an IAA on the label?
- Yes, the medical device and IVD labels must contain information about the name and registered address of the IAA.
What are the critical steps for becoming an IAA for a manufacturer?
- Some of the critical steps to be followed by a manufacturer to become an IAA-
- Having an entity registered in India
- SUGAM account registration
- Obtaining the label of Power of Attorney (POA)
What happens if I change an IAA?
- You can change your IAA at any given point in time, and the IAA should notify the CDSCO about the termination of services. Changing an IAA requires de-registration by the old IAA followed by re-registration by the new IAA and payment of registration fees. The manufacturer must make sure to add the information of the new IAA on the label.
Can my distributor in India act as an IAA?
- Foreign manufacturers may appoint importers or distributors as their IAA. However, it would be ideal to go for an independent IAA service provider as their authorized representative in the Indian market. Appointing an independent agency gives the manufacturer the flexibility to appoint multiple distributors and importers to realize their business expansion and market penetration goals.
What happens if I change an IAA?
- You can change your IAA at any given point in time, and the IAA should notify the CDSCO about the termination of services. Changing an IAA requires de-registration by the old IAA followed by re-registration by the new IAA and payment of registration fees. The manufacturer must make sure to add the information of the new IAA on the label.
What are the critical steps for becoming an IAA for a manufacturer?
- Some of the critical steps to be followed by a manufacturer to become an IAA-
- Having an entity registered in India
- SUGAM account registration
- Obtaining the label of Power of Attorney (POA)
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