Centre has notified new rules for medical devices to remove regulatory bottlenecks and ensure availability of medical devices for patients. <br/><br/>Under the new rules, manufactures will not be required to renew licenses periodically and submission of applications and grant of licenses will be done online.<br/>'<br/>To bring in the highest degree of professionalism in regulation of medical devices, a system of 'Third Party Conformity Assessment and Certification' through notified bodies accredited by the National Accreditation Board for Certification Bodies has been envisaged under the new rules.<br/>'<br/>Notified by Union Health Ministry, the rules also seek to evolve a culture of self-compliance by medical devices manufacturers and the manufacturing licences for Class A medical devices will be granted without prior audit of manufacturing site.<br/>'<br/>Under the new rules, manufacturing and import licences will remain valid till these are suspended, cancelled or surrendered. <br/><br/>The new rules have been framed in conformity with Global Harmonisation Task Force (GHTF) framework and conform to best international practices.<br/>'''''<br/>