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DCGI asks MedTech manufacturers to report adverse effects of devices

The Drugs Controller General of India (DCGI) Rajeev Raghuvanshi has directed all medical device license holders and manufacturers to report any adverse events related to life-saving medical equipment on the government’s Materiovigilance Programme of India (MvPI) platform.

The top drug regulator asked for early identification of risks associated with medical equipment, so that appropriate measures can be taken to mitigate those risks and safeguard public health.

Medical devices consist of electronic equipmen, implant, consumables and disposables, surgical instruments and in-vitro diagnostic reagents, among others.

Currently, all medical devices are regulated by the Drugs and Cosmetics Act, 1940 and Medical Device Rule, 2017. At present, India is 80% dependent on imports for medical devices.

A licence is required for importing, manufacturing or marketing such devices.

“All medical devices licence holders (should) establish robust systems and processes for the timely identification, documentation and reporting of adverse events associated with medical devices,” said Raghuvanshi in a communication to all manufacturers seen by Mint.

“As the MvPI is an important programme for reporting of adverse events, coordinated analysis etc., related to the medical devices including in-vitro diagnostic devices, therefore, all licence holders should also use the MvPI platform for reporting of any adverse or serious events associated with the devices to enhance the procedure for identifying risk associated with such equipment,” he said.

Surveillance to ensure safety
The DCGI said that post market surveillance (PMS) of medical devices is important to ensure safety and performance of medical devices and allows regulatory authorities to take appropriate measures to mitigate risks and safeguard public health.

The drug regulator also instructed licence holders and manufactures to seek training for understanding and proficiency in reporting and understanding adverse events.

“Adverse events in medical devices depend upon the classification of the product. High risk medical devices are more prone to show adverse events. Every manufacturer follows a Standard operating Procedure (SoP) laid down as per QMS. If the medical device is not complying with the defined product standards or while using the same shows reactions to the patient, then it needs to be investigated. After thorough analysis necessary corrective and preventive actions are takenas per guidelines by the manufacturer and the same needs to be informed the competent authority for further action,” said Jatin Mahajan, Secretary, Association of Diagnostic Manufacturers of India. LiveMint

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