Erba Transasia Group, India’s leading InVitro Diagnostic company, is proud to announce a groundbreaking achievement: it has become the first company in India to receive the Bureau of Indian Standards (BIS) certificate for its fully automated range of clinical chemistry analyzers, including the XL 200/EM 200 and XL 640 models.

印度领先的InVitro诊断公司Erba Transasia Group自豪地宣布了一项开创性的成就：它已成为印度第一家因其全自动临床化学分析仪（包括XL 200/EM 200和XL 640型号）而获得印度标准局（BIS）证书的公司。

This significant milestone, achieved under the IS standards 17717:2023, marks a major step forward in India’s commitment to affordable, accessible, and high-quality clinical diagnostic solutions..

根据IS标准17717:2023实现的这一重要里程碑标志着印度在致力于提供负担得起的，可获得的和高质量的临床诊断解决方案方面迈出了重要的一步。。

Government of India has launched BIS quality certification as an Indian alternative to CE quality certificate and US FDA Quality certificate. Most Erba Transasia instruments already had a CE mark. Now this BIS certification, awarded to Transasia clinical chemistry products, further underscores Erba Transasia’s commitment to upholding the highest standards of quality, safety, and reliability in its products.

印度政府推出了BIS质量认证，作为CE质量证书和美国FDA质量证书的替代品。大多数Erba Transasia仪器已经有CE标志。现在，授予Transasia临床化学产品的BIS认证进一步强调了Erba Transasia对其产品质量、安全性和可靠性的最高标准的承诺。

By obtaining this certification, Erba Transasia highlights the national significance of the BIS as a benchmark for excellence in manufacturing and regulatory compliance. This achievement also contributes to India’s growing reputation as a hub for advanced, high-quality medical technology, supporting the Make in India initiative.

通过获得该认证，Erba Transasia突显了BIS作为卓越制造和法规遵从性基准的国家意义。这一成就也有助于提高印度作为先进、高质量医疗技术中心的声誉，支持印度制造倡议。

Transasia actively advocates for the enforcement of the Quality Control Order (QCO) in the IVD sector and recommends that only BIS-certified instruments be sold in India, thereby bolstering customer trust and safeguarding public health..

Transasia积极倡导在IVD部门执行质量控制令（QCO），并建议在印度仅销售BIS认证的仪器，从而增强客户的信任并保障公众健康。。

“This achievement is a significant milestone for Erba Transasia and an important moment for India’s healthcare ecosystem. By meeting the stringent BIS standards, we are proud to deliver world-class products that are not only made in India but are accessible and affordable for the entire country,” said Suresh Vazirani, Founder Chairman of Erba Transasia Group.

Erba Transasia Group创始人兼董事长Suresh Vazirani表示：“这一成就是Erba Transasia的一个重要里程碑，也是印度医疗生态系统的一个重要时刻。通过满足严格的BIS标准，我们很自豪能够提供世界级的产品，这些产品不仅在印度制造，而且在整个国家都可以买到和负担得起。”。

“Our commitment to providing quality healthcare solutions while advancing India’s manufacturing capabilities aligns with the vision of Make in India—bringing accessible, high-quality healthcare solutions to the global market.”.

“我们致力于提供高质量的医疗保健解决方案，同时提升印度的制造能力，这与“印度制造”为全球市场带来可访问的高质量医疗保健解决方案的愿景是一致的。”。

The achievement also marks a critical step in the company’s regulatory compliance journey, with further expansion planned, including the addition of several more Erba analyzer under the BIS certification process and one of the largest IVD factories in Vizag.

这一成就也标志着该公司在监管合规过程中迈出了关键的一步，并计划进一步扩张，包括在BIS认证过程中增加几台Erba分析仪，以及在维扎格最大的IVD工厂之一。