Government of India Issues New Circular on Licensing of In Vitro Diagnostic Medical Devices
On May 15, 2024, the Directorate General of Health Services under the Ministry of Health and Family Welfare in India issued a new circular for medical devices through the Central Drugs Standard Control Organization.
The circular states that all medical devices, including in vitro diagnostic medical devices, will now be regulated under the Drugs and Cosmetics Act of 1940 and the Medical Devices Rules of 2017. A license/approval is required for the import/manufacture and marketing of devices in India.
Ensuring Quality and Safety
Licenses are issued under the aforementioned rules, subject to certain restrictions, to ensure the quality, safety and performance of medical devices on the market, as well as compliance with the Quality Management System. It is also essential that all medical device license holders have strong systems and processes in place for the timely identification, documentation, and reporting of adverse events related to medical devices.
Importance of Post-Market Surveillance
Post-market surveillance (PMS) of medical devices is a critical part of ensuring their safety and performance. PMS helps to identify and resolve any potential risks or adverse events associated with the medical device.
Timely reporting of adverse events enables the identification of unrecognized dangers, analysis of the frequency of previously identified risks, and the implementation of necessary actions by manufacturers and regulatory agencies to mitigate these risks and protect public health.
Materiovigilance Programme of India
The Materiovigilance Programme of India (MvPI), initiated by the Ministry of Health and Family Welfare, aims to improve patient safety in India by monitoring, recording and analyzing the root causes of adverse events or risks associated with the use of medical devices. This includes in vitro diagnosis by healthcare professionals or patients/users and providing appropriate resources to regulatory authorities with the sole purpose of improving patient safety.
The Indian Pharmacopoeia Commission (IPC) has been appointed as the National Coordinating Center (MvPI) for the Material Monitoring Programme of India. In addition to healthcare professionals/public/users/patients, one of the most important stakeholders in MvPI is the medical device industry, and their participation needs to be encouraged to have a significant impact on the outcome.
As MVPI is an important program for adverse event reporting and coordinated analysis of medical devices, including in vitro diagnostic devices, it is proposed that all licensees use the MVPI platform to also report potential adverse events/serious events. Device-related adverse events to improve processes for identifying risks associated with medical devices.
Reporting of Adverse Events
In view of the above, stakeholders are urged to promptly report any adverse events related to medical devices to the MvPI. Guidance documents to facilitate the effective use of MvPI resources are available on the website of the Indian Pharmacopoeia Commission (IPC) (https://www.ipc.gov.in), to help streamline reporting processes and ensure the continued safety and efficacy of medical devices in India.
We acknowledge that the above information has been compiled from Ministry of Health and Family Welfare.
