MILAN, May 30, 2024 /PRNewswire/ -- NTC, an International pharmaceutical company with headquarter in Italy, with a specific focus in ophthalmology and with a significant portfolio in gynecology and gastroenterology too, continues in its certification path and receives the fifth Medical Device Regulation (MDR) Certificate approval, this time for its hypertonic ophthalmic solution based on NaCl 5% multidose.
NTC started back in 2018 its activity plan to successfully carry its 32 Technical files of medical devices - representing north of 200 SKUs in Europe only - from the EU directive to Medical Device Regulation 2017/745 (MDR).
"To build a strong foundation and unleash sustainable growth in the future", states Riccardo Carbucicchio CEO of NTC, "we have proactively moved ahead already time ago and begun working towards meeting MDR requirements and obtaining CE marks renewals for our medical devices, according to the new EU regulation, before the deadlines. In this way, we have been trying and keep trying to secure our portfolio and give long term continuity to the agreements in place with our customers, for the benefits of many patients in the many countries where our products are marketed."
MDR intends to secure effective and safe medical devices, adequately documented, to the markets and set new standards for clinical trials too. Besides this, it provides a regulatory framework, supporting innovation and competitiveness of the medical device industry in the EU.
Silvia Regondi, Chief Operating Officer of NTC says: "The partnerships with our contract manufacturing organizations together with the expertise of our R&D, Quality, and Regulatory departments are enabling us to sustain our innovative therapeutic solutions meant to satisfy unmet medical needs for patients in Europe and beyond. We are following very respectfully the feedback we are receiving from regulatory bodies during the registration path. "
NTC adds another brick to its credibility delivering good quality files, in the context of this very important transformation in the medical device regulation in Europe.
About NTC
A pharmaceutical company headquartered in Milan - Italy, with distributors and partners in more than 100 countries, engaged in research, development, registration and commercialization of drugs, medical devices and food supplements in ophthalmology, and in other therapeutic areas including pediatrics, gynecology and gastroenterology. NTC offers to more than 200 partners innovative and high quality standard pharmaceutical products. For more information, please visit www.ntcpharma.com
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