In the intricate landscape of medical device regulations in India, the role of the Indian Authorized Agent (IAA) stands as a pivotal link between foreignmanufacturers and the Central Drugs Standard Control Organization (CDSCO). Selecting an Indian Authorized Agent marks the initial stage in entering the Indian medical device market for the foreign manufacturers.
The regulations outlined in the Medical Device Rules (MDR), 2017 mandate that international manufacturers lackinga local subsidiary in India must appointan Indian Authorized Agent (IAA). This IAA is a domestically registered entity or person responsible for submitting registration applications on behalf of the foreign manufacturer and facilitating communication between the CDSCO and the foreign entity. Indian Authorized Agent are necessary for all risk classes of medical devices and In-Vitro Diagnostic (IVD) devices. Medical device and IVD labels must include information about the IAA's registered name and address.
Foreign manufacturers have the option to designate their importers or distributors as IAAs. Nonetheless, opting for an independent IAA service provider is advisable as it offers the manufacturer the flexibility to engage multiple distributors and importers, thussupporting their business expansion and market penetration objectives.
The specific responsibilities of an IAA are contingent upon the contractual agreement between the manufacturer and the IAA. Importing devices is not an obligatory regulatory role imposed on IAAs by the CDSCO. If the IAA isn't acting as an importer, he can enable the importer to perform customs clearance tasks with the appropriate documentation.
The medical device manufacturer can appoint multiple IAAs for the same device. Subsequent IAAs must submit all documents provided by the initial IAA, along with registration fees and a copy of the import license. The application should also include a declaration asserting that there have been no changes in the Plant Master File and Device Master File (DMF).
To serve as an IAA for a foreignmanufacturer, the followingprerequisites stipulated by the CDSCOmust be met -
An IAA must be a corporation orenterprise with an activeCorporate Identification Number(CIN) established in India.
The IAA must be a resident ofIndia.
One should obtain a Power ofAttorney (POA) from the foreignmanufacturer for
medical device registration withthe CDSCO.
Possess a Manufacturing,Wholesale, or Distributor Licenseunder the Drugs and CosmeticsAct of 1940 and its 1945 Rules.
The CDSCO's online Medical Devices platform, SUGAM, serves as the submission portal for IAA registration and various application forms for device registration. The Indian Authorized Agent must first create an account on the platform before submitting any device registration application. The IAA must submit the IDproof, undertaking document, Corporate
Identification Number (CIN), contactdetails, Corporate Address proofdetails, and Manufacturing orWholesale License to register as anIAA for foreign manufacturers.
During the device registration process, the agreement between the foreign manufacturer and the IAA must be uploaded to the SUGAM portal along with manufacturer details. The CDSCO reviews this as part of the device approval process. If there are changes in the overseas manufacturer's or IAA'sconstitution, the IAA must inform the CDSCO in writing within thirty days of the change taking effect.
The foreign manufacturer may choose to change the IAA, and the new IAA should inform the CDSCO of the termination of services. This process involves the old IAA's deregistration, followed by the new IAA's registration and payment of fees. The manufacturermust ensure the new IAA's information is updated on the label.
The IAA must fulfil the responsibilitiesoutlined in the Medical Device Rules(MDR) of 2017, including:
Submitting import licenseapplications.
Liaising with the CDSCO foradditional information requestsuntil approval.
Submitting Test License forimport, test, evaluation, andclinical investigations.
Handling post-approval changesand endorsement applications.
Reporting adverse reactions,recalls, and regulatoryrestrictions within fifteen days.
Obtaining prior approval beforeimplementing major changes.
Notifying minor changes withinthirty days.
Informing about changes inmanufacturer or IAA constitutionwithin thirty days.
Post-Market Surveillance (PMS)
The role of the Indian Authorized Agent(IAA) is crucial, encompassing representation of the manufacturer or device in the Indian market, as well as the registration of the manufacturing site and the device itself. Overseas manufacturers should thoroughly evaluate prospects and delineate roles and responsibilities of stakeholders before finalizing an IAA.
Are you seeking expert guidance on medical device registration in India? Our team at Artixio is here to help you navigate the regulatory landscape, ensuring a seamless process for your medical devices. Contact us today to explore the possibilities and ensure your compliance journey is a successful one. Stay informed, stay compliant with Artixio.