- Amongst the first medtech companies 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 which are absorbable or used in the vital organs such as heart and brain]
- With EU MDR now, the company establishes its commitment of highest safety and quality standards in the implantable medical devices sector
National, 29th September 2022: Healthium Medtech Limited a global medical devices company focused on surgical, post-surgical and chronic care, today announced that the company has received the new CE certification under the stringent EU MDR (European Union’s Medical Device Regulation). As a part of the regulation for CE certification, the EU MDR accreditation is mandatory for sales to European countries and several other regulated markets. The purpose of the regulation is to ensure that manufacturers produce safe products, meeting global safety standards.
Healthium Medtech is India’s largest independent medical devices company in the surgical consumables market, the largest non-captive surgical needles manufacturer globally by volume and the third largest company overall in the urology collection devices market in UK. Healthium currently operates eight integrated and scaled manufacturing facilities, several of which have global accreditations and approvals including US FDA, TGA, CDSCO, EN ISO 13485:2016, ISO 9001:2015, CE under MDD and now CE under EU MDR.
The EU MDR necessitates more stringent measures versus the earlier CE norms under the European Union Medical Device Directive (EU MDD), keeping patient safety in mind. This means stricter compliance, increased vigilance, robust complaint handling, regular product and customer feedback procedures, and trend reporting requirements with periodic safety update reports. In addition, the UDI ID which will now be required on all devices will enhance traceability across the supply chain.
Speaking about the EU MDR accreditation, Anish Bafna, Chief Executive Officer and Managing Director, Healthium Medtech said, “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 said,“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 global medtech company focused on products used in surgical, post-surgical and chronic care. One in five surgeries conducted globally uses a Healthium Medtech product. As of fiscal 2022, it is the largest independent Indian medical device company.
In the non-captive surgical needles segment, Healthium Medtech is the largest manufacturer globally. Healthium Medtech is the third-largest company overall in urology collection devices market in the U.K. With a vision to provide access to precision medtech for every patient, globally, the Company has created extensive market access in India covering over 40,000 surgeons across 18,000 hospitals, reaching 90% of all districts in India, which have secondary healthcare facilities. It also is present across 80 countries.
The company’s diverse portfolio includes 52,000 SKUs across Advanced surgery, Urology, Arthroscopy and wound care products. With a strong focus on R & D, the company has 8 high precision, integrated and scaled manufacturing facilities with global certifications and approvals like US FDA, C.E, CDSCO, TGA and ISO. Since fiscal 2018, the company has sold 30 new products including a patented portfolio of arthroscopy products. The Company has 64 patents in US, Europe and India including pending applications. It has acquired 3 businesses in FY21 to expand market reach and its product portfolio.
