Jun 7, 2022

India’s Ministry of Health and Family Welfare finalized an amendment to the Medical Device Rules, 2017 (MDR 2017). This guidance concerning the suspension and cancellation of licenses is known as the Medical Devices (Third Amendment) Rules, 2022 and went into effect when published in the Official Gazette of India.

How can I avoid having my medical device license in India suspended or canceled?

If you are a medical device manufacturer or supplier you will want to make sure to comply with the latest rules in order to avoid suspension or cancellation of your license to import, sell or distribute medical devices in India.

The Medical Devices (Third Amendment) Rules, 2022 adds Rule 43A to the MDR 2017, which allows the Central Licensing Authority to cancel a license, suspend the license for a period, or direct the licensee to stop the import, sale or distribution of a medical device covered under the license if the manufacturer or licensee fails to comply with any of the conditions of the Import License, or any provisions of The Drugs and Cosmetics Act, 1940 or the MDR 2017.

Maintain licenses to sell or supply medical devices in India in good standing

As we have previously reported, there are a series of requirements for application and maintenance of a registration certificate to sell or distribute medical devices and in vitro diagnostic (IVD) devices in India.

To apply for registration certification in India, you must:

  • Pay applicable fees
  • Sign a self-certificate of compliance to Good Distribution Practices (GDP)
  • Provide your identification and details
  • Provide details of competent and qualified technical staff who will sell or distribute the device

Once a registration certificate has been granted, you as the certificate holder are responsible for maintaining inspection records. India’s state licensing authorities will conduct inspections as well. Registration certificates do not expire. However, certificate holders must pay a retention fee within five years of issuance. Failure to pay the retention fee will result in license cancellation.

Emergo by UL will post updates to India’s medical device regulatory guidance as it becomes available.

Learn more about medical device regulations and compliance in India from Emergo by UL:

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  • Kathryn Burke's picture
    Kathryn Burke

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