Who is an IAA?
An Indian Authorized Agent (IAA) is a person, firm, or organization who has been appointed by an overseas manufacturer through a power of attorney to undertake the import of medical devices in India. The IAA collaborates extensively with manufacturers to understand their products and Regulatory needs and assist them in navigating the complex Indian Regulatory landscape. The IAA can be either individuals or companies who are registered with the Central Drugs Standard Control Organization (CDSCO), and they must have the requisite qualifications and expertise to represent foreign medical device manufacturers.
The Challenges Faced by Foreign Medical Device Manufacturers
Here are some of the difficulties encountered by foreign medical device manufacturers while entering the Indian market:
- Language Barriers: They face communication challenges when engaging with local stakeholders, including regulators and customers.
- Navigating the Regulatory System: Navigating the Indian Regulatory system can be intricate and demanding, especially for foreign manufacturers who are unfamiliar with the local regulations and requirements.
- Supply Chain and Logistics: The complicated and fragmented supply chain in the Indian market may pose difficulties for foreign manufacturers seeking to distribute their products efficiently.
The Benefits of Appointing an IAA
- Expertise: The IAA is well versed in handling India’s medical device Regulatory landscape.
- Local Presence: The IAA assists foreign manufacturers in establishing a footprint in the Indian market and developing relationships with customers and stakeholders.
- Compliance: The IAA helps manufacturers adhere to the Indian Regulatory standards for medical devices and securing the required approvals and licenses.
- Cost-effective: Engaging an IAA is a cost-effective approach for foreign manufacturers entering the Indian market, as it eliminates the need for a local office or staff in India.
Roles and Responsibilities of an IAA
An IAA must fulfill the following responsibilities detailed under the Medical Device Rules (MDR), 2017:
- Submission of the import license application.
- Coordination with the CDSCO for any additional information request until approval.
- Import test licence submission for testing, evaluation, and clinical research.
- Post-approval changes and endorsement applications.
- Post-marketing activities.
- Notification of any adverse reaction, recalls, and Regulatory restrictions within fifteen (15) days.
- Obtaining prior approval before the implementation of any major changes.
- Notification of minor changes within a period of thirty (30) days.
- Informing of any change in the constitution of the manufacturer or the IAA within thirty (30) days.
The specific responsibilities of an IAA are determined by the business contract between the foreign manufacturer and the IAA. However, to operate as a medical device importer and distributor with the CDSCO in India, they must adhere to the Regulatory requirements set forth by the organization. By adhering to these standards, an IAA can ensure the safety, efficacy, and compliance of imported and distributed medical devices in accordance with Indian regulations. The following are some of the specific responsibilities of the IAA, in keeping with the CDSCO regulations:
- Registration: The IAA must register with the CDSCO before acting as an importer. The process entails the submission of an application using the drug wholesale license 20B/21B or MD-42 license, along with the necessary documentation such as CIN number and corporate address proof. Once these are in place, the IAA can register with the CDSCO and obtain SUGAM credentials.
- Labeling and Packaging: The IAA is responsible for ensuring that medical devices comply with Indian labeling and packaging standards. This encompasses providing essential details such as the importer’s name and address, device name, intended usage, batch number, and expiration date.
- Licenses and Permits: To import and distribute medical devices in India, the authorized agency must get an import license using Form MD-14 from the Central and state authorities under the MDR 2017. Class A non-sterile and non-measuring devices are exempt from import license requirements, while Class C and D devices would require licenses after October 01, 2023.
- Quality Control: The IAA bears the responsibility of ensuring that medical devices meet the quality standards established by the CDSCO. This entails conducting rigorous quality control testing and inspections while adhering to all the relevant guidelines and standards.
- Adverse Event Reporting: The IAA must report any adverse events associated with medical devices to the CDSCO. This encompasses diligently maintaining records of such events and submitting them to the CDSCO, as per the required protocols.
- Compliance with Other Regulations: The IAA must adhere to all other relevant regulations, including those concerning customs clearance, import/export documentation, and tax obligations. Compliance with these regulations is crucial for ensuring smooth operations and legal compliance throughout the import and distribution process.
To conclude, entering the Indian market can pose challenges for foreign medical device manufacturers. Appointing an IAA ensures that foreign manufacturers gain the flexibility to serve as distributors and importers, thereby achieving their business expansion and market entry goals. At Freyr, our experts can guide you through all the necessary Regulatory requirements. To learn more, contact us today. Stay informed! Stay compliant!