India’s plan to bring all medical devices under one regulatory framework will boost credibility, says GlobalData

India’s recent draft notification to bring all imported and locally-made medical devices under single regulatory framework and a compensation plan for patients affected by faulty devices will boost credibility, says GlobalData, a leading data and analytics company.

GlobalData’s research reveals that the the Indian medical devices market, which accounted for more than 13% of the Asia-Pacific medical devices market in 2018, is expected to grow at a compound annual growth rate (CAGR) of 7.4% through 2025.

Rohit Anand, Medical Devices Analyst at GlobalData, comments: “Currently, the Indian medical device regulatory approvals have been complex. Majority of the medical devices in India are imported and manufacturers use the US FDA and CE approval to leverage device registration.”

Against this back drop, the Ministry of Health and Family Welfare (MoHFW) in India has recently proposed to cover all medical devices that are manufactured in India or imported to get regulatory certification from the Central Drugs Standard Control Organization (CDSCO).

In addition, the Central Expert Committee of the Drugs Technical Advisory Board (DTAB) has submitted a compensation policy for regulated medical devices to MoHFW.

After the implementation of compensation policy, manufacturers and importers of medical devices will have to pay compensation to patients in case of an injury or death using a malfunctioning or unsafe device.

Anand concludes: “A streamlined approval process and a comprehensive compensation policy will improve compliance and reduce the road blocks for patient compensation in case of faulty medical devices.”

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