Stability of the welded part of the bare tube and cutting surface of the material, which will not rupture even when thinly drawn: The ratio between the fractured and sheared surfaces is agreed to facilitate welding by medical device manufacturers. The same end-face properties are supplied for the entire coil length (0.2 mm: approx. 4,000 M). (Graphic: Business Wire)
KUALA LUMPUR, Nov 1 (Bernama) -- Tokyo-based Nippon Kinzoku Co Ltd announced it is moving closer to expanding sales of its “NK-304LCO” stainless steel for injection needles into overseas markets.
The stainless steel commercialised in November 2020, which is compliant with the cobalt composition regulation of the European Medical Devices Regulation (MDR), which came into effect in May 2021 and will be fully transitioned on Dec 31, 2028.
In a statement, Nippon Kinzoku said currently, the company has started selling the amount equivalent to approximately three per cent of the cobalt-regulated materials for customers using its stainless steel material for injection needles.
The complete transition to MDR has been postponed from May 2024 to December 2028, volumes are currently increasing slightly due to the regulatory approach of individual medical manufacturers, but enquiries from the European and Chinese markets are increasing and sample shipments have already begun.
Conventional NK-304NKM stainless steel for injection needles was difficult to adapt to this regulated quantity, but in response to requests from domestic and overseas medical device manufacturers, the company has succeeded in alloy design (composition adjustment) as a result of discussions with raw material manufacturers and it is able to successfully supply the material.
The NK-304NKM has been selected as the material of choice for "thin diameter" types of needles for insulin such as "painless needles" and cosmetic applications, currently being used worldwide.
The sales share of its materials for injection needle applications is approximately 49 per cent in Japan and 59 per cent overseas, with an average share of approximately 55 per cent, and its quality superiority is widely recognised in the injection needle market.
In addition to maintaining a high market share, sales to the Chinese and Indian markets are expected to expand in the future due to the increasing number of diabetes patients worldwide.
The MDR is a regulation for marketing medical devices in Europe and is a stricter approval system than the existing Medical Device Directive (MDD), and stipulates the Regulation on Classification, Labelling and Packaging of substances and mixtures (CLP), which targets the cobalt component contained in stainless steel as a carcinogen, which is less than 0.1 percent.
-- BERNAMA
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