Indian Authorised Agent

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The Indian Authorisation Agent for the Registration of Medical Devices in India.

Indian medical device rules are changing rapidly, so manufacturers need to keep up with the latest developments. According to the Medical Device Regulations (MDR) of 2017, foreign manufacturers that do not have a local subsidiary in India are required to designate an Indian Authorised Agent (IAA), which is a legally registered body or individual who would apply for registration on the manufacturer’s behalf. If a foreign manufacturer without an establishment in India wishes to join the Indian market, it can designate an authorised agent to register and promote its devices there. A foreign company’s authorised agent in India is a person or organisation in India. The authorised agent will be in charge of the foreign company’s import of medical devices in India, including full compliance with the Drugs and Cosmetics Act regulations. An authorised agent can apply for medical device registration in India with the Central Licensing Authority and must hold a current Manufacturing license or Registration Certification MD-42 intended for the sale and distribution of goods and services in India.
Regulatory Framework for Medical Devices in India

India regulates medical devices under the Medical Device Rules, 2017 (effective from January 1, 2018), under the broader Drugs and Cosmetics Act, 1940. The CDSCO is responsible for overseeing the safety, efficacy, and quality of medical devices entering the Indian market. Before a medical device can be imported, marketed, or sold in India, it must be registered with the CDSCO.

Definition of an Indian Authorized Agent

An Indian Authorized Agent is a person or legal entity based in India, legally empowered by a foreign manufacturer to act on their behalf with respect to medical device registration and regulatory compliance in India. The Authorized Agent represents the manufacturer in dealings with the CDSCO and other Indian authorities concerning product registration, post-market surveillance, adverse event reporting, and product recalls, among other responsibilities.

The duties, responsibilities, and qualifications of an India Authorised Agent

The duties, responsibilities, and qualifications of an India Authorised Agent
 An India Authorised Agent is a local individual or business that handles a range of duties, such as but not restricted to the following. Here are the basic requirements for an Indian Authorized Agent:

  •   An India Authorised Agent is a local individual or business that handles a range of duties, such
  •   as but not restricted to the following:
  •   Submit all the documents to CDSCO for registration on your behalf.
  •   Take on the role of the device’s official importer and oversee its import and distribution within India.
  •   Act as a regulatory liaison for the CDSCO and you.
  •   If required, monitor the reporting of Serious Adverse Events (SAEs) on your device.
  •   Assistance in order to keep your device registered.
  •   Your Authorised Agent will possess your medical device registration in MD-15, sometimes referred to as an import licence in India, once the CDSCO has authorised your goods.
Requirements for an Indian Authorized Agent

There are certain prerequisites for an entity to become an Indian Authorized Agent for the registration of medical devices:

Registered Entity in India

   – The Authorized Agent must be a legal entity that is registered in India. This can be a private limited company, partnership firm, or any other recognized entity under Indian law.

   – The foreign manufacturer cannot act as its own Authorized Agent unless it establishes a branch or subsidiary in India.

Power of Attroney – Power of Attorney and undertaking from the designated representative in accordance with MDR, 2017’s Fourth Schedule, Part I (duly recognised in India by a magistrate or either by the Indian Embassy in the nation of origin or by a comparable power by the apostille.

Relevant Licenses

   – Depending on the type of medical device, the Indian Authorized Agent must obtain relevant licenses, such as the Wholesale Drug License for medical devices, or the Import License for importing the devices or Manufacturing license.

  • Wholesale license: Medical Device Registration certificate MD-42/ wholesale license
  • Online System for Medical Devices portal: You’ll need to authenticate and register your organization through this portal. 

The Authorized Agent must also ensure that they comply with any other local licensing or registration requirements for medical devices.

Why the Indian Authorized Agent is Important for Foreign Manufacturers

For foreign manufacturers, partnering with a capable Indian Authorized Agent is critical to successfully navigating the complex regulatory landscape of India. Here’s why:

– Local Expertise: The Indian regulatory environment is complex and continually evolving. An experienced Authorized Agent understands the local laws and can effectively manage regulatory submissions, reducing delays and ensuring compliance.

– Streamlined Processes: The Authorized Agent facilitates smooth interactions with regulatory authorities, helping foreign manufacturers avoid common pitfalls during the registration process.

– Accountability: By appointing an Authorized Agent, foreign manufacturers have a reliable partner who can manage post-market surveillance, adverse event reporting, and other regulatory obligations, ensuring product safety and compliance.

– Faster Market Access: A competent Authorized Agent can accelerate the process of getting medical devices approved, allowing manufacturers to bring their products to market more quickly.

Conclusion

The role of the Indian Authorized Agent is essential for foreign medical device manufacturers looking to enter the Indian market. This intermediary ensures compliance with India’s regulatory requirements, facilitates product registration, and manages post-market surveillance, thus ensuring that medical devices sold in India are safe, effective, and meet the necessary quality standards.

Appointing a competent Authorized Agent with a thorough understanding of the regulatory landscape is not just a legal requirement but also a strategic decision that can significantly impact the success of a medical device in India.

Medfins helps Indian authorized agents by:

– Providing regulatory compliance support: Ensures that medical devices meet Indian standards and regulations for approval.

– Assisting with market access: Helps in navigating the Indian healthcare market for smooth product entry.

– Facilitating product registrations: Guides in the submission and management of product registration processes.

– Supporting documentation and clinical trials: Offers assistance with the preparation of required documents and conducting clinical trials.

– Liaising with CDSCO: Acts as an intermediary between foreign manufacturers and the Central Drugs Standard Control Organization (CDSCO).

– Streamlining license and approval processes: Ensures efficient handling of necessary licenses and approvals for medical products.

FAQs

An IAA should have a strong understanding of Indian regulatory requirements, experience in the medical device industry, and knowledge of import/export procedures.

If an IAA fails to comply with regulations, it can lead to penalties for both the IAA and the foreign manufacturer, including fines and potential loss of license or registration.

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Yes, an IAA can handle marketing and distribution, but the specific responsibilities should be clearly defined in the agreement with the foreign manufacturer.

The appointment of an IAA is typically valid for a specified duration as outlined in the agreement, after which it may be renewed or terminated.

Yes, a foreign manufacturer can replace or change their IAA, but this process should be carefully managed to ensure compliance with regulations and a smooth transition.