Indian Authorized Agent Service for Medical Devices
Choosing an Indian authorized agent for launching medical devices in India
Foreign companies planning to enter the Indian medical devices market will need an authorized agent for registration of medical devices. Understanding the local requirements and regulations for medical devices registration can be difficult. Foreign companies without any office or operations in India will need Indian authorized agent service to enter the Indian medical device market. Thus, it is vital to wisely choose an “Indian Authorized Agent” for launching your medical device in India.
Pharmadocx Consultants: Your trusted Indian authorized agent service provider
The Indian authorized agent for medical devices oversees a foreign manufacturer’s regulatory compliance and import operations in India.
We at Pharmadocx Consultants have the expertise to provide Indian authorized agent service. As an authorized agent, we assist foreign companies aiming to enter the Indian medical devices market. The Pharmadocx Consultants team has valid IEC Code, ISO 13485, and CDSCO MD42 licenses. These licenses enable selling and distribution of medical products and services.
Additionally, we have the expertise to file applications with the Central Licensing Authority for Medical Device registration.
Our specialization is simplifying the complex process of registration and licensing of a medical devices business in India.
Who is an Indian authorized agent for medical devices?
As per CDSCO guidelines, all manufacturers/importers planning to sell medical devices in India mandatorily need the CDSCO registration and license. Any foreign manufacturer, not having local presence in India, planning to distribute and sell medical devices in India needs to appoint an Indian Authorized Agent (IAA). The agent will oversee compliance of your medical device with Indian regulations. Furthermore, the Indian authorized agent for medical devices acts as a liaison between foreign manufacturers and Indian regulatory authorities. Moreover, the appointed agent will work on behalf of the foreign company and act as a point of contact. As stated in Medical Devices Rules, 2017, Chapter 1, any entity given a power of attorney by an international manufacturer to import medical devices into India is an “Indian authorized agent.”
Why should you not appoint any importer or distributor as your Indian authorized agent?
- The primary focus of importers and distributors is marketing and sales. They may not have in-depth knowledge of the Indian regulatory requirements for medical devices.
- While preparing the necessary documents, such as the Device Master File, the design information will be inevitably revealed to the distributor or importer.
- Reporting of adverse events and product recalls may lead to conflict of interest.
- If you use an importer or distributor as your medical device authorized agent, you will be obligated to maintain the same distributor for the five-year period. With no option for registration certificate transfer, for changing your distributor, you will have to start your registration afresh.
Basic eligibility requirements for a medical device authorized agent
A local entity needs to meet certain criteria before becoming eligible to provide Indian authorized agent service.
- Must be an Indian resident
- Must possess a valid wholesale license under 20B and 21B
- Must possess an active Corporate Identification Number (CIN) and be a registered corporation or enterprise in India
- Must have a registered account in the official CDSCO online portal, SUGAM
- Must have been the legal authority to act on behalf of foreign companies and process the CDSCO registration
How will the authorized agent help you?
The agent is legally responsible for the medical devices being marketed in India. The Indian authorized agent service for medical devices covers the following responsibilities:
- The agent will be the point of contact with the CDSCO for the foreign manufacturer.
- The medical device authorized agent will submit the application for medical device registration using the agent’s account on SUGAM
- The agent will relay the application status and any query raised to the foreign manufacturer.
- The authorized agent will convey the importer’s name and address and import license number to the foreign manufacturer. This information will be included on the device label or shelf pack.
- The authorized agent for medical devices will carry out the import process at the customs port office.
- The agent will be responsible for reporting any complaints or adverse events that occur during the licensing period.
- The agent will carry out post market surveillance activities for the medical device in India
- It is the responsibility of the Indian authorized agent to ensure compliance with the regulatory requirements of the respective state licensing authority.
- The agent will be responsible for reporting any changes in the device or manufacturing facility post license issue. The agent will relay this information to the CDSCO.
- Five years post license issue, the authorized agent has to apply to the central licensing authority to renew the license. The agent will have to pay the license retention fee.
Thus, the medical device authorized agent will assume the responsibility for the medical device in India. Moreover, all applications from the foreign manufacturer must be channelled via the Indian authorized agent. Furthermore, it will act as the primary interface between the overseas manufacturer and CDSCO.
Pro tips for choosing your Indian authorized agent
It is difficult for a foreign medical device manufacturer to oversee operations at the local level in India. Operating a medical device business in India has extensive requirements from understanding regulatory guidelines, taxation policy to logistics. This is where Indian authorized agent service comes into picture. The agent will provide all the support you need to launch and successfully establish a medical device business in India.
Choosing a qualified authorized agent for medical devices is essential to enter the Indian medical device market. The agent will navigate the regulatory affairs and be your gateway to the Indian market.
Pro tips
- Assess the expertise of the agent in the category to which your medical device belongs to. Gauge the suitability of the agent for your unique medical device requirements.
- Verify whether they have experience with Quality Management System (QMS) compliance. This will be essential for obtaining the necessary certifications.
- Find an agent with an understanding of the Indian medical device market. The agent can provide insights into the distribution channels and potential challenges faced in India. This local physical presence will facilitate communication and compliance.
- Check the registration status of the agent with the CDSCO as an Indian authorized agent for medical devices.
- Find an agent with a proven track record and presence in the Indian medical device industry. Understand the roles and responsibilities of an agent so that you can identify one with a deep understanding of India’s regulatory landscape.
- An agent who provides timely and clear response to queries and effectively relays updates on regulatory matters is extremely valuable.
- Choose an agent who wishes to maintain a long-term relationship with your company, as regulatory requirements and compliance are ongoing.
- Gather references and recommendations from other medical device manufacturers.
Pharmadocx Consultants as your Indian authorized agent
India being a global potential hub for medical devices is attracting various foreign medical device companies. However, foreign manufacturers planning to enter the Indian market need Indian authorized agent service.
With the CDSCO MD42 license, IEC Code, and ISO 13485 certification, we are uniquely positioned to serve as Indian authorized agents. Our expertise in CDSCO regulations for medical devices will help you launch your medical devices in India without regulatory hassle. Pharmadocx Consultants cater to overseas manufacturers by handling their import requirements while ensuring compliance with the stringent CDSCO regulations.
With our authorized agent service and support, foreign companies can easily enter the Indian medical devices market. We will help you establish a local presence in India. Let us be your trusted partner for establishing your medical devices business in this potential hub.
Looking for an Authorised Agent in India for Medical Devices? Contact us now!
Pharmadocx Consultants Indian authorized agent service includes
- Securing CDSCO import license to import medical devices into India for sale and distribution
- Import assistance and hassle-free custom clearance
- We will help you effectively implement quality management and control for maintaining product quality and regulatory compliance
- Assistance and support for smooth logistics and warehousing
- Post-market surveillance, product performance evaluation, and if required, product recall
Why choose Pharmadocx Consultants?
Medical Device Licences
Years Experience
Plants Set-up
Our prestigious clients
FAQs
Who needs to avail Indian authorized agent service?
Foreign medical device companies without any operational establishment in India need Indian authorized agent service. The agent will act on behalf of the foreign company for importing the device and regulatory compliance.
Why should I choose Pharmadocx Consultants as my Indian authorized agent?
With the CDSCO MD42 license, IEC Code, and ISO 13485 certification, we are uniquely positioned to serve as Indian authorized agents. Moreover, we have extensive experience in CDSCO regulatory guidelines and regulations. Furthermore, our team will take care of all the legal as well as regulatory obligations. With our assistance and support you can easily establish your medical device business in India.
In addition to authorized agent service, what additional support will Pharmadocx Consultants provide?
Pharmadocx Consultants provide all-encompassing CDSCO regulatory support. We can help you obtain various certifications, such as ISO 13485, and create documents, such as plant and device master files. Additionally, we provide quality and risk management and post market surveillance services.
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