• The Central Drugs Standard Control Organization(CDSCO) in India has called for medical device manufacturers to establish a system for promptly identifying and disclosing adverse events related to their products.

• This is to ensure compliance with the Quality Management System and to notify the Materiovigilance Programme of India (MvPI) of any adverse incidents.

• The government also mandates post-market surveillance (PMS) to identify and address potential risks related to medical devices.

• Prompt reporting of adverse events helps manufacturers and regulatory authorities mitigate risks and protect public health.

• The goal of the MVPI, which was previously introduced by the health ministry, was to increase patient safety through the observation, documentation, and analysis of the underlying causes of unfavorable events or risks related to the use of medical devices, including in-vitro diagnostics, by patients, healthcare professionals, and users.

• Subsequently, the regulatory bodies would be recommended for suitable action.

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