The new first of its kind “On-line National Registry for Cardiac Stent” has been launched successfully? by DRAP. This On-line National registry is unique in a way that for the first time a medical device national registry provides registration for Importer/manufacturer and cath lab/ medical institution. Thus on one hand “Supply side” , where importer and manufacturer of cardiac stent will provide their cardiac stent import data including reference of importation, source (manufacturer), spec, lot no., expiry, quantity, rate and amount, thus will? bring a complete transparency. In addition the importer at the time of sale and supply will provide its sale Invoice information with its product details and institution to which these are sold. Whereas on the “Usage or utilization side” the cath labs/ medical institution will provide its purchase data and its patient usage details along with utilized stent data so as to provide a complete track and trace system. This registry provides a restricted access which is pass word protected therefore only users registered with DRAP can access their data on the national registry for cardiac stent. According to new regulatory frame work for medical devices, under the directive of federal government, about 38 importers have been registered and got their Establishment certificates mostly within 3 days after completing the simplified requirements and more than forty new stent products have been registered by now, through a simplified? process while ensuring the life saving devices only from high quality assured manufacturers licensed from the stringent authorities of reference countries and certified Conformity Assessment Bodies (CAB), accredited with European Union authority. This initiative has been developed and successfully launched by the new dedicated MIS team of DRAP, timely fulfilling? their commitment, in the larger interest of patients.
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