An Indian Authorized Agent is an intermediate between the foreign manufacturer and the regulatory authority. Any foreign manufacturer who intends to sale its therapeutic product in India is required to appoint a local agent who handles all the regulatory requirements in India on behalf of the foreign manufacturers.
It is thus the sole responsibility of the medical device import agent in India to ensure the product meets all the requirements in terms of its safety, efficacy and quality. The medical device representative should ensure the compliance with the CDSCO regulations and should prevent the product from being recalled and strive for a successful product achievement in the Indian market.
Responsibilities of an Indian Authorized Agent for Medical Devices Import
A CDSCO authorized agent for medical device must fulfill the following responsibilities detailed in the Medical Device Rules (MDR), 2017 to be able to import medical devices:
1. Submit the import license application
2. Liaise with the CDSCO in case of any additional information request until approval
3. Submission of Test License for import, for the test, evaluation, and clinical investigations
4. Post-approval changes and endorsement applications
5. Post-marketing surveillance activities
6. Notify any adverse reaction, recalls, and Regulatory restrictions within fifteen (15) days
7. Obtain prior approval before implementation of any major changes
8. Notify minor changes within a period of thirty (30) days
9. Inform any change in the constitution of the manufacturer or the IAA within thirty (30) days
Criteria for becoming an Indian Authorized Agent / Representative
1. Foreign manufacturers may appoint importers or distributors as their IAA.
2. To act as a foreign manufacturer’s IAA, the following are the prerequisites,
3. Be any corporation or enterprise established in India with an active Corporate Identification Number (CIN).
4. Be a Resident of India.
5. Obtain Power of Attorney (POA) from the foreign manufacturer for medical device registration with the CDSCO.
6. Have a Manufacturing or Wholesale or Distributor License (MD40,41,42).
7. Should have SUGAM account registration
Must have the legal authority to take decisions on behalf of the foreign manufacturers.
The regulatory reforms by CDSCO for governing medical device manufacturing, import and sale in India has added more responsibilities on Indian Authorized Agent to ensure quality and safety of medical device in India.
Key Points To Look In While Selecting Your Indian Authorized Agent:
The selection of the Indian Authorized Agent (IAA) plays a vital role as it is mandatory to enter the Indian market. Below are some of the key points to consider while selecting the medical device import authorized agent:
Verify and authenticate the agent’s experience with the CDSCO regulations and previous experience in the same domain.
Select an agent who responds to your queries and doubts quickly, in time and effectively.
Select an agent who is known for his long-term relationship.
Choose an agent with QMS compliance experience.
The Indian agent should have registration for medical devices.
Choose Artixio As Your Trusted Indian Authorized Agent:
At Artixio, we aim at providing the best regulatory service for your medical device compliance with the CDSCO with our experienced local team members who provide intelligence driven regulatory solution tailored for your medical device. Artixio guides the manufacturers for:
Timely compliance with CDSCO.
Supports for market access as well as post marketing surveillance.
Tips for minimum chances of product recall.
Ensuring the correct and authentic documents submission to the CDSCO.
So, partner with Artixio today for your successful medical device journey in India. For more details contact info@artixio.com
FAQs:
1. What are the requirements that the Authorized Agent should meet with?
CDSCO authorized agent for medical device should have Wholesale License for sale (20B/21B or renewal in 21C) or distribution of medical devices, or a Registration Certificate (MD-42) and they should also register with the Online System for Medical Devices portal.
2. Can multiple Authorized Agents be appointed?
Yes, the manufacturer can appoint multiple Authorized Agents if he wants to, but then each one of them should have their own registration and import license for the medical device.
3. Can the Indian Authorized Agent be changed for the same medical device by the foreign manufacturer?
Yes, the foreign manufacturer can change the Indian medical device authorized representative by notifying the CDSCO and transferring the registration in compliance with the regulations.
4. Can Authorized Agents also handle distribution and marketing of medical devices?
The authorized agent is mainly responsible for the regulatory compliance of the medical devices while he can also handle distribution and marketing if the manufacturer wants him to handle, but it should be included in the contract between the manufacturer and the CDSCO compliances representative.
5. How is the Indian Authorized Agent authorized?
The medical device import authorized agent in India can be authorized by documenting power of attorny by the manufacturer.
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