Arni Medica receives CDSCO test licences for more than 160 IVD products
Arni Medica has received test licences (Form MD-13) from the Central Drugs Standard Control Organisation (CDSCO) for more than 160 in-vitro diagnostic (IVD) products. It is a defining step in our growth from medical devices into diagnostics.
What this milestone means
A test licence authorises us to manufacture these products for testing, performance evaluation, demonstration and training. Over the coming months, our team at the Medical Devices Park, Hyderabad, will use this stage to complete the product evaluation and technical documentation that commercial manufacturing licences require.
Built on an established quality system
Our facility is certified to ISO 13485:2016 and ISO 9001:2015 and already manufactures medical devices under a manufacturing licence issued under the Medical Devices Rules, 2017. The IVD portfolio is being built on the same quality management system, cleanroom infrastructure and regulatory discipline.
The portfolio
The licensed products span our diagnostics portfolio.
For laboratories, hospitals and distribution partners
We welcome conversations with laboratories, hospital groups and distributors who would like to take part in product evaluation or discuss future supply and distribution partnerships. Please write to sales@arnimedica.com.
