For the first time: Online National Registry for Cardiac Stent introduced
Registration facility aims to bring transparency in sale and usage of the device.
Court takes up fraud case of fixing substandard stents in cardiac patients. PHOTO: REUTERS
ISLAMABAD:
The Drug Regulatory Authority of Pakistan (DRAP) has for the first time launched an ‘Online National Registry for Cardiac Stent’ to bring transparency in both the sale and usage of the tube-shaped medical device that is installed to keep arteries open in the treatment of coronary heart disease.
On the supply side, importers and manufacturer of cardiac stents will provide their import data to DRAP’s online registration facility. The data will include details like reference of importation, manufacturers’ name, specifications, lot number, expiry, quantity, rate and amount.
Faulty stents: CJP expands scope of cardiac fraud case
At the time of sale and supply, importers will also provide their sale Invoice information, product details and name of institution to which these stents are sold.
On the usage or utilisation side, catheterisation labs and medical institutions will provide to the registry their purchase data and their patient usage details and utilised stent data to provide a complete track and trace system for the device.
The registry provides a restricted access which is password-protected to ensure that only users registered with DRAP can access their data on the national registry.
Non-maintainable: Court dismisses plea against cardiac stents
According to new regulatory framework for medical devices, DRAP has registered about 38 importers and got their establishment certificates after completing the requirements. More than 40 new stent products have been registered by now, through a simplified process.
According to a statement, DRAP ensures that the life-saving devices are registered only from high quality 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,” it said.
The Drug Regulatory Authority of Pakistan (DRAP) has for the first time launched an ‘Online National Registry for Cardiac Stent’ to bring transparency in both the sale and usage of the tube-shaped medical device that is installed to keep arteries open in the treatment of coronary heart disease.
On the supply side, importers and manufacturer of cardiac stents will provide their import data to DRAP’s online registration facility. The data will include details like reference of importation, manufacturers’ name, specifications, lot number, expiry, quantity, rate and amount.
Faulty stents: CJP expands scope of cardiac fraud case
At the time of sale and supply, importers will also provide their sale Invoice information, product details and name of institution to which these stents are sold.
On the usage or utilisation side, catheterisation labs and medical institutions will provide to the registry their purchase data and their patient usage details and utilised stent data to provide a complete track and trace system for the device.
The registry provides a restricted access which is password-protected to ensure that only users registered with DRAP can access their data on the national registry.
Non-maintainable: Court dismisses plea against cardiac stents
According to new regulatory framework for medical devices, DRAP has registered about 38 importers and got their establishment certificates after completing the requirements. More than 40 new stent products have been registered by now, through a simplified process.
According to a statement, DRAP ensures that the life-saving devices are registered only from high quality 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,” it said.