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New services for Indian medical device manufacturers announced

IANS  |  Benguluru 

German testing and certification major TUV SUD has announced a range of services for medical device manufacturing sector in India, six months ahead of the crucial revision of European Union's (EU) Medical Device Regulations (MDR).

accounts for 1.3 per cent 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.

TUV SUD -- currently the world's largest notified body for all types of medical devices covered by 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 be a formidable stakeholder in the global manufactural stage and contribute significantly towards the Make in 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 Notified Bodies, Kumar said.

--IANS

rt/sm/dg

(This story has not been edited by Business Standard staff and is auto-generated from a syndicated feed.)

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New services for Indian medical device manufacturers announced

German testing and certification major TUV SUD has announced a range of services for medical device manufacturing sector in India, 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, six months ahead of the crucial revision of European Union's (EU) Medical Device Regulations (MDR).

accounts for 1.3 per cent 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.

TUV SUD -- currently the world's largest notified body for all types of medical devices covered by 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 be a formidable stakeholder in the global manufactural stage and contribute significantly towards the Make in 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 Notified Bodies, Kumar said.

--IANS

rt/sm/dg

(This story has not been edited by Business Standard staff and is auto-generated from a syndicated feed.)

image
Business Standard
177 22

New services for Indian medical device manufacturers announced

German testing and certification major TUV SUD has announced a range of services for medical device manufacturing sector in India, six months ahead of the crucial revision of European Union's (EU) Medical Device Regulations (MDR).

accounts for 1.3 per cent 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.

TUV SUD -- currently the world's largest notified body for all types of medical devices covered by 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 be a formidable stakeholder in the global manufactural stage and contribute significantly towards the Make in 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 Notified Bodies, Kumar said.

--IANS

rt/sm/dg

(This story has not been edited by Business Standard staff and is auto-generated from a syndicated feed.)

image
Business Standard
177 22

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