Indian medical device regulations are undergoing a major transformation, and all the medical devices and IVDs are now regulated by the CDSCO. All the devices should be registered with the CDSCO. The foreign manufacturers importing the devices into India must now appoint an Indian Authorized Agent (IAA). There are apprehensions about choosing and appointing an IAA, and the current article decodes the major questions posed by the medical device and IVD manufacturers.
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.
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.
Yes, the medical device and IVD labels must contain information about the name and registered address of the IAA.
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)
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.
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.
Yes, the manufacturer can appoint multiple IAA for the same devices. The second and subsequent IAAs shall submit all the documents submitted by the first IAA and registration fees along with a copy of the import license. The application shall also be accompanied by a declaration that there are no changes in the Plant Master File and Device Master File (DMF).
The responsibilities of an IAA depend on the business contract agreed between the manufacturer and the IAA. Importation of devices is not a Regulatory responsibility imposed on IAA by the CDSCO. In cases where your IAA is not acting as an importer, the IAA can enable the importer to carry out customs clearance activities with the support of necessary documents.
As a part of the device registration process, the agreement made between the foreign manufacturer and the IAA must be uploaded to the SUGAM portal along with the manufacturer details. The CDSCO reviews this as a part of the device approval process.
Yes. In the event of any change in the constitution of the overseas manufacturer or IAA, the IAA shall, within a period of thirty days (30) from the day the change is in effect, shall inform the CDSCO in writing.
An IAA must fulfill the following responsibilities detailed in the Medical Device Rules (MDR), 2017:
- Submit the import license application
- Liaise with the CDSCO in case of any additional information request until approval
- Submission of Test License for import, for the test, evaluation, and clinical investigations
- Post-approval changes and endorsement applications
- Post-marketing activities
- Notify any adverse reaction, recalls, and Regulatory restrictions within fifteen (15) days
- Obtain prior approval before implementation of any major changes
- Notify minor changes within a period of thirty (30) days
- Inform any change in the constitution of the manufacturer or the IAA within thirty (30) days
PMS is the responsibility of the manufacturer’s IAA. In case of any violation of the Drugs and Cosmetics Act, 1940 (23 of 1940) and the Medical Devices Rules, 2017, an IAA shall continue to be held responsible even after withdrawing the Power of Attorney for the devices imported into India.
The Indian Authorized Agent (IAA) plays a vital role not only in representing the manufacturer or the device in the Indian market but also in the registration of the manufacturing site and the device. The overseas manufacturers shall carry out a detailed evaluation of the prospects and clearly define the roles and responsibilities of individual stakeholders before finalizing an IAA.
Read more about India’s medical device regulations or reach out to an expert at Freyr. Stay informed. Stay compliant.