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Anurag More, Mumbai July 01 , 2022
Freudenberg Medical, a global contract manufacturer focused on solutions that address the complex challenges of medical device and pharmaceutical industry, is planning to introduce several new products in 2022 and beyond in the fluid handling space for biopharma. These include extensions of current PharmaFocus Premium product line and a new product line.

"In June itself, we have launched a new product ‘HelixTC’. This is a new range of over-molded Tri-Clamp ends with in-built gaskets for silicone tubing that serve as a safe and unique alternative to conventional barbed TC connections,” said Falgun Jani, head of sales, Freudenberg Medical India.

‘HelixTC’ can become an ideal choice for critical fluid transfer applications in pharmaceutical and bioprocess operations as it greatly reduces bioburden entrapment and leakage situations associated with conventional barb-type TC fittings. HelixTC ends are manufactured in a certified clean room with material certification and lot traceability and are available in standard and custom sizes, he further said.

"Freudenberg Medical is able to support customers worldwide from its two like-for-like manufacturing sites fitted with the same top-of-the-line manufacturing equipment, software and quality systems along with easy and faster availability of standard and braided silicone tubing from our off-the-shelf ready stocks." he said.

Talking about medical devices market Jani adds, "The Aatmanirbhar Bharat Abhiyaan packages include several short-term and long-term measures for the health system, including production-linked incentive (PLI) schemes for boosting domestic manufacturing of pharmaceuticals and medical devices. Medical devices market in India is one of the top 20 medical device markets in the world. It is currently valued at US$ 5.2 billion and is expected to reach US$ 50 billion by 2025. However, India does not manufacture many devices indigenously and still imports approximately 70 per cent of its medical devices. In India, there were no specific medical device regulations and devices were regulated under the Drugs and Cosmetics Act, 1940. To fulfill this gap, Central Drug Standard Control Organization had released Indian Medical Device Rules, 2017, which are the new regulations for medical devices in India. Keeping pace with the requirements, these were amended as Medical Devices (Amendment) Rules, 2020, which has come into force in April 2020".

He further said, "Currently, the medical device development process is very complex and is time-consuming. Its approval is one of the most structured processes, which is highly regulated and governed by Indian Medical Device Rules (IMDR) 2017 and Medical Devices (Amendment) Rules, 2020. These rules cover various aspects of device-related regulations, including classification, registration, manufacturing and import, labelling, sales, and post-market requirements, etc."

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