06 Jan 2015

DIGITALEUROPE response on Indian CRO

DIGITALEUROPE response on Indian CRO

DIGITALEUROPE would like to contribute views and suggestions on the recent Gazette notification of 7th November 2014 on the extension of the CRO to a further 15 categories by the Department of Electronics & information Technology, Government of India.

While the industry appreciates the efforts made by the DeitY, we see scope for improving the process of registration and aligning to global norms in this sector. There are opportunities for DeitY to ensure that regulations like CRO provide a platform for all stakeholders to achieve the intended benefits.

We recommend CB test reports be allowed to be accepted as an mutual recognition option to the Incountry BIS test lab reports as part of the CRO registration process towards issue of the BIS approval. Also only Safety testing be asked for against India standard or equivalent global standard, given its relevance to safety of the end consumer Moreover we encourage DeitY to revisit the timeline of the CRO expansion for all of the products listed in the Notification, DIGITALEUROPE believes that the proposed transition period of six months is too short. Our concern is that requiring component level approvals for products such as power adapters, batteries, UPS, etc. before system level approvals are granted will effectively result in a bottleneck and prevent products from entering the Indian market. If DeitY intends to enforce using BIS certified components in host products, we expect that a transition period much longer than six months is needed to allow local labs to deal with the surge in test and registration activity. Without such an extension we expect that many of these products would not be available for the India market due to delays in BIS registrations of these components (battery, adaptors)

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