Full Licensing Requirement for Class C and D Medical Devices in India
Introduction:
On April 12, 2023, the Central Drugs Standard Control Organization (CDSCO) of India issued a circular reminding Indian manufacturers and importers that all Class C and Class D non-notified medical devices, which currently require mandatory registration, will now need a full license starting from October 1, 2023. This blog aims to provide an overview of the new licensing regime and assist you in transitioning to the new license requirements for Class C and Class D medical devices.
Full License Requirement for Class C and Class D Non-Notified Medical Devices
To begin with, let’s understand what is meant by non-notified medical devices. These are medical devices that have come under the purview of the licensing regime following the adoption of the expanded definition for Medical Devices by the Ministry of Health & Family Welfare in February 2020. (Uncertain whether your device is non-notified or not? We can assist you in determining that.)
The deadline for the full license requirement marks the final step in transitioning Class C and Class D non-notified medical devices to the licensing regime. Currently, all Class C and Class D non-notified medical devices are exempt from requiring a manufacturing/import license and can be manufactured/imported into India based on their mandatory registration with CDSCO. However, starting from October 1, 2023, it will be mandatory to obtain a license for introducing such devices in India.
For Medical Device Importers:
Obtaining a CDSCO medical device import license in India can take up to six months after the submission of the application. The preparation for the application submission is also a time-consuming process, typically taking 1–3 months depending on the level of preparedness of an organization. Therefore, it is crucial for all importers of Class C and Class D non-medical devices to apply for the import license at the earliest to avoid any disruption in business after October 1, 2023.
For Medical Device Manufacturers:
Similarly, obtaining a medical device manufacturing license in India is a time-consuming process that involves extensive documentation and an inspection by a Medical Device Officer from the Central Licensing Authority (CLA) within 60 days of application submission. Therefore, if you haven’t initiated the application process yet, it is urgent to do so now in order to maintain business continuity.
Conclusion:
The transition from mandatory registration to manufacturing/import license for Class C and Class D non-notified medical devices represents the final step towards implementing the full licensing regime for such devices. Manufacturers and importers need to be aware of the new regulations and take proactive steps to obtain the necessary licenses. Since CDSCO may take up to six months to issue a license, there is an urgent need for impacted importers and manufacturers to commence their application process immediately if they haven’t done so already. Timely compliance will not only prevent disruptions in the supply chain but also ensure continued access to these medical devices for patients.
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FAQ
- What are Class C and Class D Medical Devices in India?
According to the Medical Device Rule of 2017, medical devices in India are classified into four categories: Class A, Class B, Class C, and Class D, based on their intended use, level of risk, and other factors. Class C and Class D medical devices are considered to have a moderate to high risk and are subject to stricter regulatory requirements compared to Class A and Class B medical devices.
