MUMBAI, November 28, 2016 /PRNewswire/ --
- Revised Norms Likely to be Implemented by Mid 2017
- TÜV SÜD is the World's Largest EU Notified Body for all Types of Medical Devices
- TÜV SÜD Offers a Complete Range of Services to Manufacturers of Medical Devices, Helping Them to Manage Risks, Protect and Promote the Health and Safety of Patients
Ahead of the crucial overhaul of the decade old EU
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India accounts for 1.3 percent of the global medical devices market which is worth USD 335 billion. Industry reports suggest that, backed by the 'Make in India' initiatives, the sector is estimated to grow to USD 8.6 bn by 2020 in India. TÜV SÜD is currently the world's largest EU notified body for all types of medical devices covered by EU directives and regulations. TÜV SÜD's preparedness over six months ahead of the final revisions is set to give Indian exporters considerable lead time to realign their backend and be compliance-ready as and when the new regulations come into play.
Talking about this development, Mr. Suresh Kumar, Sr. Vice President, Consumer Product Services - TÜV SÜD South Asia said, "Companies partner with TÜV SÜD globally, because we help them comply with the most updated regulations across the globe. This time around, the change in regulations will bring about a radical shift in the way medical devices are manufactured and exported to the EU. Acceptance at a large scale will help India be a formidable stakeholder in the global manufactural stage and contribute significantly towards the 'Make in India' story. In addition to our existing partners, we invite all the media device manufacturers in India, to partner with us to improve their acceptability in global markets. We look forward to exciting times in the industry."
As a part of the newly announced set of services, TÜV SÜD will provide updated information in a timely manner through various communication modes such as webinars, whitepapers and information factsheets. Through knowledge sharing, TÜV SÜD will enable medical device manufacturers to stay fully informed about the anticipated changes, and prepare to aid in achieving compliance with the new requirements.
The proposed MDR differs in several important ways from the EU's current directives for medical devices and active implantable medical devices. However, the actual terms of proposed regulations will be finalised only at the time until final publication of the MDR in the Official Journal of the European Union. As a result, the complexities involved in the anticipated changes are likely to make the transition a time-consuming process for medical device manufacturers. Some of the anticipated changes include mandatory unique device identification (UDI) mechanisms and increased post-market oversight by EU Notified Bodies.
Represented in over 850 locations worldwide, TÜV SÜD holds accreditations in Europe, the Americas, the Middle East, Asia and Africa. By delivering the services to our customers, it adds tangible value to businesses, consumers and the environment.
About TÜV SÜD
TÜV SÜD is a leading international service organisation catering to the strategic business segments - Industry, Mobility and Certification. Headquartered in Munich, Germany and founded in 1866, it has over 20,000 employees representing more than 800 locations throughout the world. Optimising technology, systems and know-how, the interdisciplinary specialist teams act as process partners to strengthen their customers' competitiveness.
About TÜV SÜD South Asia
TÜV SÜD South Asia is the leading consulting, testing, inspection and certification (TIC) company with presence across India, Bangladesh and Sri Lanka. With more than 1300 employees, TÜV SÜD South Asia has serviced over 10,000 clients to date through the past two decades. It is present at 30 locations including 16 labs across the three countries. Today, TÜV SÜD South Asia is internationally competent to provide TIC solutions cutting across a wide range of sectors that include management systems, conventional and renewable energy, water, sanitation, environmental technology, infrastructure, transit systems, real estate, food, supply chain, agriculture, toys, consumer electronics, textiles, leather and related products, automobile and components, and technical as well as soft-skills training.
For further details visit http://www.tuv-sud.in/
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