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India Certification Made Easy

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BIS – BUREAU OF INDIAN STANDARDS

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CDSCO Approval

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What is CDSCO?

The Central Drug Standard Control Organisation (CDSCO) is responsible for the so called CDSCO registration, or CDSCO approval, of all drugs and medical devices in India.

 

Here is a brief video about the CDSCO registration, presented by Julian Busch, director of
MPR International GmbH / China Certification Corporation:

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You can also watch this video on our Video Channel.

 

India is an extremely lucrative target market for our clients, with a Medical Market size of several billion USD. As in other areas of the Indian certification landscape, standards and CDSCO certification regulations are still being developed. Every year new products are added to the lists and existing standards are being updated.

As of January 1, 2020 the following medical products need to be registered with and approved by the CDSCO in India:

CDSCO accreditation obligations can generally be found in published CDSCO notifications. For every application the CDSCO also refers to the elaborately worded BIS standards (the “Indian Standards” – IS), so that even if your product is not listed in CDSCO notifications, the authority might decide that your product should be registered and tested. The application for CDSCO approval is required to include completed application documents as well as the product accreditation in the country of origin and needs to be submitted by an Authorized Indian Representative (AIR).

In India, all medical products are categorized into “risk classes” A through D, each with different application requirements: with A being the lowest risk category to D as the highest risk category. The Central Licensing Authority (CLA) within the CDSCO is responsible for the classification of products into one of these 4 risk classes. CDSCO Approvals for risk classes A and B are issued by the State Licensing Authority (SLA), whereas approvals for risk classes C and D need to be applied for with the CLA directly. Only products of risk class A can be approved prior to testing in India. In any case, it is up to the CDSCO to decide whether a factory inspection should be done or not. This decision is crucially influenced by whether your product already has approval in your own market.

Please also be aware that after CDSCO certification, the CDSCO is entitled to conduct Post-Market Surveillance. That means that the authority may at any time request recent test reports or samples to be tested in India.

You can find more information on our CDSCO Service Package (CDSCO Registration Service Package) here.

For more information regarding the CDSCO certification, please read our free information booklet “CDSCO Registration – The Booklet“.

 

 

 

 

 

 

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