– Meets highest security and high quality requirements as a medical gadgets producer
- Amongst the first medtech firms in Asia to receive CE clearance under the EU MDR norms after an onsite facility audit, fulfilling the pre-requisites drawn in the MDR
- 1st Indian Medtech Company to receive CE clearance under the stringent EU MDR norms for Class III implants (Implants that are absorbable or used in the very important organs akin to coronary heart and mind)
- With EU MDR now, the firm establishes its dedication of highest security and high quality requirements in the implantable medical gadgets sector
BENGALURU, India, Oct. 3, 2022 /PRNewswire/ — Healthium Medtech, a world medical gadgets firm centered on surgical, post-surgical and continual care, at the moment introduced that the firm has acquired the new CE certification under the stringent EU MDR (European Union’s Medical Device Regulation). As part of the regulation for CE certification, the EU MDR accreditation is obligatory for gross sales to European nations and a number of different regulated markets. The objective of the regulation is to be sure that producers produce protected merchandise, assembly international security requirements.
Healthium Medtech is India’s largest unbiased medical gadgets firm in the surgical consumables market, the largest non-captive surgical needles producer globally by quantity and the third largest firm total in the urology assortment gadgets market in UK. Healthium presently operates eight built-in and scaled manufacturing amenities, a number of of which have international accreditations and approvals together with US FDA, TGA, CDSCO, EN ISO 13485:2016, ISO 9001:2015, CE under MDD and now CE under EU MDR.
The EU MDR necessitates extra stringent measures versus the earlier CE norms under the European Union Medical Device Directive (EU MDD), holding affected person security in thoughts. This means stricter compliance, elevated vigilance, strong grievance dealing with, common product and buyer suggestions procedures, and development reporting necessities with periodic security replace studies. In addition, the UDI ID which can now be required on all gadgets will improve traceability throughout the provide chain.
Speaking about the EU MDR accreditation, Anish Bafna, Chief Executive Officer and Managing Director, Healthium Medtech stated, “We are delighted to receive the CE certification under EU MDR. At Healthium, we strive towards achieving the highest safety and quality standards for better clinical outcomes. The certification is a testimony to our continuous commitment to operational excellence and our focus in delivering the same high quality, safe, value driven products not only to the EU but also in India and other countries. This is aligned with our vision of facilitating access to precision medtech for every patient, globally.”
Dr. Ashok Moharana, Chief Medical Officer, Healthium Medtech additional provides, “The CE certification under EU MDR reinforces our growing capabilities at Healthium towards innovation, safety, quality and clinical research for providing holistic solutions for clinicians and the patient community. EU MDR signifies a milestone for the medtech fraternity and clearly supports our calibrated efforts to bring the highest safety and quality standards for improving patient outcomes across our key therapeutic areas. We will continue to rise up the value chain by adhering to the highest standards in patient safety.”
About Healthium Medtech Limited:
Healthium Medtech Limited is a world medtech firm centered on merchandise used in surgical, post-surgical and continual care. One in 5 surgical procedures carried out globally makes use of a Healthium Medtech product. As of fiscal 2022, it’s the largest unbiased Indian medical system firm. In the non-captive surgical needles section, Healthium Medtech is the largest producer globally. Healthium Medtech is the third-largest firm total in urology assortment gadgets market in the U.Okay. With a imaginative and prescient to present entry to precision medtech for each affected person, globally, the Company has created intensive market entry in India protecting over 40,000 surgeons throughout 18,000 hospitals, reaching 90% of all districts in India, which have secondary healthcare amenities. It is also current throughout 80 nations.
The firm’s numerous portfolio consists of 52,000 SKUs throughout Advanced surgical procedure, Urology, Arthroscopy and wound care merchandise. With a robust concentrate on R&D, the firm has 8 excessive precision, built-in and scaled manufacturing amenities with international certifications and approvals like US FDA, C.E, CDSCO, TGA and ISO. Since fiscal 2018, the firm has bought 30 new merchandise together with a patented portfolio of arthroscopy merchandise. The Company had 64 patents in US, Europe and India together with pending functions. It has acquired 3 companies in FY21 to broaden market attain and its product portfolio.
