Medical devices in India are regulated by the Central Drugs Standard Control Organization (CDSCO), under the Ministry of Health and Family Welfare. The regulatory framework for medical devices in India has been evolving, and there have been significant changes in recent years, including the introduction of a separate regulatory framework for medical devices under the Medical Devices Rules, 2017.
If you are a foreign manufacturer of medical devices, you are typically required to appoint an Indian Authorized Representative under Medical Device Rules, 2017. This representative plays a crucial role in ensuring that your devices comply with Indian regulations. They act as a liaison between your company and the regulatory authorities in India.
Requirements for Indian Authorized Representative
To serve as an Indian Authorized Agent or Representative for Foreign Manufacturers and act on their behalf in India, a local entity must meet specific requirements. The entity should:
- Be a resident of India.
- Be a registered corporation or enterprise in India, holding an active Corporate Identification Number (CIN).
- Possess a valid wholesale license under 20B and 21B.
- Have the legal authority through a Power of Attorney to submit medical device registration documents to the CDSCO.
- Must have a registered SUGAM Account
CDSCO Registration of an Indian Authorized Representative
The Indian Authorized Agent are also required to validate and register their company or organization via the Online System for Medical Devices portal. Once this process is completed, they will be granted access to submit Import License applications, which essentially serve as device registration applications.
Here are the steps to follow:
- Visit the CDSCO Portal and initiate the account creation process. Click on the “Sign-up / register” option to get started.
- From the dropdown menu listing various registration purposes, select “import of medical devices.”
- To register as an Indian Authorized Representative (IAR) for a foreign manufacturer, you will need to provide the following documentation: ID proof, Undertaking document, Corporate Identification Number (CIN), contact details, corporate address proof, and a Manufacturing or Wholesale license issued under sections 20B and 21B.
Role of Indian Authorized Representative
For all foreign manufacturers of medical devices and in vitro diagnostics (IVDs) categorized into any of the risk classes seeking registration and market entry in India, the appointment of an Indian Authorized Representative (IAR) is mandatory. The IAR serves as the primary interface with the CDSCO throughout the application process and assumes responsibility for the device in India once it is imported into the country. All applications from foreign manufacturers must be channelled through the IAR via the official online portal for medical devices. It’s worth noting that CDSCO audits are not conducted for Indian Authorized Representatives.
Responsibilities of an Indian Authorized Representative
The regulatory obligations of Indian Authorized Representative include –
- Obligated to initiate submissions through their individual accounts on the SUGAM online portal for Medical Devices.
- Act as the point of contact with the CDSCO regarding the application status or any inquiries related to the product.
- Assist the foreign manufacturer by furnishing the Import License number, as well as the importer’s name and address for inclusion on the device label or shelf pack.
- Take charge of importation procedures at the customs port office.
- Assume responsibility for conducting Post Market Surveillance activities for the device in India.
- Report any complaints, adverse events, or serious adverse events that occur during the licensing period.
- Notify the CDSCO of any alterations made to the device or manufacturing facility after the license has been granted.
- Ensure compliance with all other prerequisites as stipulated by their respective state licensing authority.
Importer or distributor as an IAA
When an importer or distributor also serves as an Indian Authorized Agent (IAA), there can be certain implications:
- The process of compiling the Device Master File and submitting the registration application may involve revealing design information to the distributor or importer. Their primary emphasis is often on sales and marketing, rather than regulatory matters.
- After device approval, you may find yourself obligated to maintain the same distributor for a five-year period or to re-register the device with a new Indian Authorized Representative (IAR). This dual role can potentially lead to conflicts, particularly concerning incident reporting and recalls, where the roles as a distributor or importer may not align with those as an authorized agent.
Changing the Authorized Representative
Indian regulations do not offer provisions for transferring the responsibilities of an Authorized Agent linked to a registered medical device. Consequently, manufacturers are obliged to secure distinct registrations for the same device when dealing with different distributors. Consequently, the possibility of having multiple registrations for the same device exists. Import Licenses are unique to the Authorized Agent/Importer, and a change in the Authorized Agent necessitates the submission of a new Import License application to the CDSCO through the newly designated Authorized Agent.
Appointing Multiple Indian Authorized Agents for a device
When a manufacturer intends to collaborate with several importers in India, they have the option to designate multiple Authorized Agents. However, it’s important to note that each Authorized Agent must individually obtain their own registration and Import License for the specific device. It’s no longer feasible to appoint a standalone Authorized Agent separate from the device’s importer because only the Authorized Agent who holds the registration is authorized to import products under the registration issued in their name.
Choosing an Indian Authorized Representative
When faced with numerous options for appointing an Indian Authorized Representative (IAR), the task of finding a qualified one can sometimes be challenging. Foreign manufacturers have the choice to designate their distributor, establish a subsidiary, or appoint an independent agent as their Indian Authorized Agent. Here is a concise guide on how to make this choice for your device:
- Gain a comprehensive understanding of the roles and responsibilities attributed to an Indian Authorized Representative.
- Identify Qualified Representatives who boast a strong track record and possess experience within the medical device industry, coupled with a deep understanding of India’s regulatory landscape.
- Verify their registration status as an authorized representative with the CDSCO.
- Assess their expertise concerning your specific medical device category.
- Ensure they have experience with Quality Management System (QMS) compliance, as this is essential for assisting in obtaining the necessary certifications and ensuring your devices align with Indian standards.
- Select a representative who exhibits responsiveness to your inquiries and delivers clear, timely updates on regulatory matters.
- Seek a representative who possesses a keen understanding of the Indian medical device market, encompassing knowledge of distribution channels and potential challenges.
- Request references or explore recommendations from other medical device companies that have previously availed their services.
- Consider the advantage of having a local physical presence, as it can facilitate communication and bolster compliance efforts.
- Confirm that your chosen authorized representative is fully prepared for potential regulatory audits and inspections conducted by Indian authorities.
- Opt for a representative who expresses a long-term commitment to your business, recognizing that regulatory requirements and compliance are ongoing, evolving processes.
Appointing an Indian Authorized Representative
Selecting the right Indian Authorized Agent is just the beginning of the process. Once you have identified a potential Indian Authorized Representative:
- Gain a thorough understanding of the costs and fees associated with the Indian Authorized Representative services. While cost is a factor, your primary focus should be on their qualifications and their ability to meet your specific needs.
- Engage in comprehensive discussions, conduct a thorough assessment of their qualifications, and determine their suitability for your unique medical device requirements.
- Emphasize the importance of your representative’s understanding of the need to protect your proprietary information and maintain confidentiality regarding product details. Ensure you have a Non-Disclosure Agreement in place with the selected IAR.
- Formalize a clear and comprehensive legal agreement that defines the roles, responsibilities, and obligations of both parties. This document should comply with both Indian and international legal standards.
- Request regular reports to keep you informed about the regulatory status of your devices in India. Open and transparent reporting is essential for a successful partnership.
If you are a medical device manufacturer located outside of India and in search of Indian Authorized Representative Services, 8chealthcare is the ideal option for you. Feel free to contact us at contact@8chealthcare.com
