India Certification made easy

With its many independent authorities and processes, the certification landscape in India is quite a challenge to navigate. Do you need AIS/TAC, BIS, TEC, WPC, CDSCO or PESO registration or want to find out whether you need it? With us as your professional partner you can safely and easily obtain your India certification.

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AIS – Automotive Industry Standard

India Certification is an excellent partner for the AIS/TAC certification in the automotive sector. We are providing leading automotive suppliers and car manufacturers with quick and smart solutions for their TAC certification. We offer you our support for every project related to the Automotive AIS.

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BIS – Bureau of Indian Standards

India Certification is an excellent partner for the BIS certification for electronic products. The list of products requiring accreditation is extended regularly. We are providing leading manufacturers with quick and smart solutions for their India certification. With us you will navigate the Indian certification landscape safely.

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TEC – Telecommunication Engineering Center

India Certification is an excellent partner for the TEC certification for telecom equipment. Certification requirements change constantly and the list of products that require TEC approval is extended regularly. We will identify certification requirements of your product and make sure that you will obtain your TEC registration swiftly and reliably.

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WPC – Wireless Planning & Coordination Commission

India Certification is an excellent partner for the WPC certification for wireless products. We will clarify if certification is necessary for your product and if yes, what test requirements exist. We will ensure that tests are conducted correctly and that you will obtain your WPC registration swiftly and reliably.

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CDSCO

Medical devices and pharmaceuticals need CDSCO approval before they can be sold in India. We offer the evaluation of CDSCO classifications (Classes A – D) for your medical device and guide you through the complete CDSCO approval processes.

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Other services

We offer many other certifications and services for the Indian and many other markets. Whether one of the certifications for the Automotive, Electronics or Telecommunications industries, the approval for a medical product, or even just a temporary shipment for other purposes: We support you throughout the entire process.

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Consulting

India Certification provides a range of specialized consulting services, especially for car manufacturers and large industrial companies. With the consulting packages the certifications as well as internal procedures related to international product certifications can be streamlined.

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Training

India Certification offers customized certification training to fit your company needs. Our trainer will come to your location and provide the training, up to date information and pass on valuable tips from our many years of experience. Call us today to learn more!

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About us

Since 2005, India Certification (MPR International GmbH) has been supporting companies around the world in obtaining the required product certifications for the Asian markets. With a strong team located worldwide, we can offer you the best solution for your enquiries.

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Certification Process

Before applying for a CDSCO certification of a medical product in India, it is recommended you carefully search the CDSCO announcements for specific information regarding your product first. The authority may additionally consult more detailed BIS standards and decide based on those, whether a product shall be approved or not.

The manufacturer is not allowed to file the CDSCO approval application for import or even import his products by himself. Manufacturers are required to name an Authorized Indian Representative (AIR) to represent them in all dealings with the authority CDSCO in India. This AIR must have a valid wholesale license to be eligible to apply for an import license.

 

Here is a brief video about the CDSCO certification, 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.
 

For each product risk class (A, B, C, or D) there are different CDSCO accreditation application requirements for both the manufacturer and the importer.

The application will likely require certain application forms, manufacturer information, technical data sheets, ISO certificates, IFU, test reports, clinical data as well as the accreditation in the country of origin. All documents will need to be available in English.

It is up to the CDSCO to decide whether it wants to conduct an inspection of your factory. Generally, such an audit is required if your product is not yet approved in your own market. When this factory inspection should be done is different for each risk level.

In some cases the certification authorities also request for a personal technical presentation at the CDSCO to better understand the product. At this meeting a technical representative of the company as well as the Authorized Indian Representative (AIR) are required to appear in person.

New product types will undergo a review by the Subject Expert Committee (SEC) or could be put to further tests if it is a special innovation (new technology, new material, new application). Clinical data in India could also be requested ahead of CDSCO approval.

Products within risk class A can be imported immediately and only have to be tested within 4 months after the initial CDSCO registration. Products of risk classes B, C and D are required to be tested prior to import. If required, factory inspections for risk levels A & B can be done after approval and import, for risk levels C & D they however need to be done before. For products of risk class D, only the National Institute of Biologicals (NIB) in India is accredited to conduct tests.

For some in-vitro devices a test report from an appropriately accredited test lab in another large regulated market can be accepted.

After the successful completion of all steps of the CDSCO certification of medical products in India, the authority will issue an import license to all officially awarded AIRs. This license has to be renewed every five years.

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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