Six months ahead of the crucial revision of European Union's (EU) Medical Device Regulations (MDR), German testing and certification major TUV SUD has announced a range of services for medical device manufacturing sector in India.
India accounts for 1.3 percent of the global medical devices market which is worth $335 billion and backed by the 'Make in India' initiatives, the sector is estimated to grow to $ 8.6 billion by 2020, as per industry reports.
‘India accounts for 1.3 percent of the global medical devices market which is worth $335 billion and backed by the 'Make in India' initiatives, the sector is estimated to grow to $ 8.6 billion by 2020.’
TUV SUD -- currently the world's largest EU notified body for all types of medical devices covered by EU directives and regulations -- announced a revised range of services that 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, the report said.
"We invite all the medical device manufacturers in India, to partner with us to improve their acceptability in global markets. 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," Suresh Kumar, Senior Vice President (Consumer Product Services) at TUV SUD South Asia, said in a statement.
As part of the newly announced set of services, TUV SUD will provide updated information in a timely manner through various communication modes such as webinars, whitepapers and information factsheets.
Through knowledge sharing, TUV SUD will also enable medical device manufacturers to stay fully informed about the anticipated changes, and prepare to aid in achieving compliance with the new requirements.
The change in regulations is poised to bring about a radical shift in the way medical devices are manufactured and exported to the EU. Some of the anticipated changes include mandatory unique device identification (UDI) mechanisms and increased post-market oversight by EU Notified Bodies, Kumar said.