AUTHORIZED REPRESENTATIVE (MEDICAL DEVICES - INDIA)

REGULATING MEDICAL DEVICES

To place medical devices on the market in India, non-local companies must comply with regulatory requirements set by the Central Drugs Standard Control Organization (CDSCO) and the Medical Devices Rules, 2017.

Effective April 1, 2020, the status of a medical device expanded beyond the 23 previously notified medical devices, requiring that all medical devices be registered under The Drugs and Cosmetics Act of 1940. Beginning October 1, 2022 all Class A and B medical devices must have Import Licenses prior to importation. All remaining Class C and D devices not already Notified will need to have Import Licenses by October 1, 2023. Medical devices that do not currently require Import Licenses must still register their product(s) through an ePortal in a couple of days.

COUNTRY AUTHORIZED REPRESENTATIVE RESPONSIBILITIES

Non-local companies may need to appoint an authorized representative in India, depending on the specific device and regulatory requirements.

The authorized representative can assist with regulatory submissions and communication with Indian authorities.

Referred to as the license holding agent, they are granted power of authority. Their name is also listed on local labelling, liason with customs and is responsible for vigilance issues through notifying CDSCO.

Here is a summarized overview of the key compliance requirements with an emphasis on the role of the authorized representative:

1. Product Registration:

• Non-local companies must register their medical devices with the CDSCO before they can be legally marketed and sold in India.
• Registration involves submitting detailed documentation about the device's safety, quality, and efficacy.

2. Authorized Representative:

3. Quality Management System (QMS):

• Medical device companies must establish and maintain a QMS compliant with ISO 13485 or other applicable standards.
• The CDSCO may audit the QMS to ensure compliance.

4. Labeling and Packaging:

• Medical device labeling and packaging must comply with Indian regulations, including language requirements and specific labeling content.
• The authorized representative may help ensure proper labeling and packaging.

5. Clinical Data and Testing:

• Depending on the risk classification of the device, clinical data and testing may be required to demonstrate safety and efficacy.
• Non-local companies must provide this data as part of the registration process.

6. Post-Market Surveillance:

• Companies must establish a system for monitoring and reporting adverse events or product defects to the CDSCO.
• The authorized representative may assist with reporting obligations.

7. Fees and Payments:

• Non-local companies are typically required to pay registration fees and other associated charges.
• The authorized representative can assist in handling these financial transactions.

8. Compliance with Indian Laws:

• Non-local companies must adhere to all Indian laws and regulations related to medical devices.
• The authorized representative plays a role in ensuring ongoing compliance.

9. Notification of Changes:

• Any changes to the medical device or its manufacturing process must be promptly reported to the CDSCO through the authorized representative.

10. Periodic Inspections:

• The CDSCO may conduct periodic inspections of the manufacturing facilities, storage facilities, and records of non-local companies through the authorized representative.

In summary, non-local companies looking to place medical devices on the market in India must adhere to a range of regulatory compliance requirements.

The role of the authorized representative, if required, is vital in facilitating compliance, regulatory submissions, and communication with Indian authorities.

Collaborating effectively with the authorized representative is essential for navigating the regulatory landscape in India successfully.