Singapore, Sep 24, 2007: The Department of Science & Technology, Government of India has proposed to bring in a new legislation to enforce uniform and effective standards of Medical Devices throughout the country. This will ensure that substandard devices are not exported, especially to developing countries, which do not have medical devices regulation in place.
Mr Kapil Sibal, Union Minister for Science & Technology and Earth Sciences, Government of India said, “The government has also proposed to create a Regulatory Authority that will seek to establish and maintain a national system of certification relating to quality, safety, efficacy and availability of medical devices.”
He further said, “At present the medical device regulation is managed by the application of quality systems in Design, Development and Manufacture and Conformity with various standards. Medical Device Regulations have become non-tariff barriers in international trade. Hence promotion and growth of Medical Devices industry in the country requires effective and prudent regulation incorporating the current accepted principles of Global Harmonizing Task Force (GHTF).”
Even within the country, the Central Government is responsible for pre-market approval whereas post market surveillance is the responsibility of State Government. This was not applicable to Medical Devices, since Medical Devices would require uniform quality throughout the country, he added.
The Minister said, “Failure of medical devices could be fatal. Complex implantable devices can be handled only by a professionally qualified multidisciplinary team. Some medical devices may emit or be affected by electromagnetic interferences and need to be adequately safeguarded. Disposal of medical devices also poses special problems in view of environmental issues. Hence, some sort of regulatory mechanism was required to put in place.
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