Health Policy

Government of India to introduce medical devices regulation bill

The Department of Science & Technology has proposed to bring in a new legislation to enforce uniform and effective standards of Medical Devices throughout the country so as to ensure that substandard devices are not exported, especially to developing countries, which do not have medical devices regulation in place and also for use within the country. 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. Kapil Sibal, Union Minister for Science & Technology and Earth Sciences said, as of today, 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-TARRIF 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). He added that 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 explained that a very wide and diverse range of medical devices were in use today, ranging from very simple devices with low risks (e.g. steel implants) to very sophisticated devices (e.g. heart valves) with significant risks. They use a variety of technologies and are manufactured from Small and Medium Enterprises (SMEs) to multinationals. Their duration of use also vary from a few minutes to permanent nature. Most devices have to be sterile, some are for single use and some are reusable. Shri Sibal further stated that 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, the Minister said.

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