The Medical Devices Development Centre at National University of Science & Technology has secured the cardiac stents manufacturing license from Drug Regulatory Authority of Pakistan
In a phenomenal breakthrough that would have far-reaching positive dividends for the country, the Medical Devices Development Centre (MDDC) at National University of Sciences & Technology (NUST) has secured the manufacturing licence from Drug Regulatory Authority of Pakistan (DRAP) for the mass production of Cardiac Stents and PTCA (Angioplasty) Balloon Catheters.
This licence is a mandatory requirement to manufacture any medical device in Pakistan, which is obtained after critical inspection of facility by the team of inspectors appointed by DRAP.
In his remarks on this meritorious accomplishment, Lt Gen Naweed Zaman, HI (M), (Retd), Rector NUST, said that this is a significant regulatory milestone achieved by NUST, that will save millions of dollars of foreign exchange to the national exchequer.
He termed it an encouraging news for the nation to celebrate amidst a pandemic COVID-19 that has been taking a huge toll on the people across the world.
Rector NUST acknowledged the financial support and patronage provided by the Government of Pakistan through its Ministry of Planning Development & Special Initiatives as well as Ministry of Science & Technology (MoST).
This is indeed a great achievement by the scientists and MDDC team at NUST, after having previously obtained Quality Management System (QMS) ISO 13485:2016 Certification from European accredited/notified body for the manufacturing of medical devices at NUST.
Consequent upon the award of this mandatory licence on March 20, 2020, NUST is now authorised to initiate production of cardiac stents – these would be available at a fraction of the price of imported ones, bringing cardiac stents within the reach of a common man, as opposed to formidably expensive imported ones.
MDDC has already successfully carried out non-clinical, pre-clinical (animal) and clinical (human) trials on the indigenously produced stents at some of the best certified European testing facilities.
MDDC is a state-of-the-art facility for the manufacturing of high-risk medical devices, including cardiac stents and angioplasty balloon catheters.