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Industry & Economy - Medical & Surgical Equipments
FICCI seeks single authority to regulate medical devices sector

Our Bureau

New Delhi, Dec. 31 In response to the proposed Drugs and Cosmetic Amendment Bill on concerns of the medical devices industry, FICCI has written to the Government recommending numerous measures including separately defining the term ‘Clinical Investigation’ (trial) for medical devices and changing the title of the Act to ‘Drugs, Cosmetics & Medical Devices (Amendment) Act 2007.

In the proposed Drug Consultative Committee, FICCI has suggested providing adequate representation to the industry in the various expert working groups that would be responsible for framing specific guidelines.

The industry chamber has also sought for a single authority to regulate affairs and implementation of the regulations in stages as per WHO guidelines so as to give the industry adequate preparation time to comply with the norms.

Further, FICCI has asked the regulations to be in line with the practices developed by Global Harmonisation Task Force as well as international standards like ISO and IEC which would prepare the domestic medical device industry to meet the regulatory requirement of major export markets.

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