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.

read more

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.

read more

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.

read more

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.

read more

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.

read more

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.

read more

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.

read more

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.

read more

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!

read more

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.

read more

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:

Dieses Video kann leider nur geladen werden, wenn Sie der Verwendung von Drittanbieter Cookies & Skripten zustimmen.

Sie haben zu einem früheren Zeitpunkt eine Auswahl zur Verwendung von Cookies & Skripten von Drittanbietern getroffen.

Klicken Sie hier um Ihre Auswahl zu ändern oder Ihre Zustimmung aufzuheben.

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:

  • Blood Pressure Monitoring Device
  • Digital Thermometers
  • Glucometers
  • Nebulizers
  • All Implantable Medical Devices
  • CT Scan Equipment
  • X-Ray Machines
  • MRI Equipment
  • Dialysis Machines
  • Bone Marrow Cell Separators
  • Defibrillators
  • PET Equipment

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“.

 

 

 

 

 

 

Third party cookies & scripts

This website uses cookies & scripts. For optimal performance and advertisement purposes it is recommended that you agree to the use of cookies by third parties & scripts. We do not share information about your use of our website with social media.
For more information, please see our Privacy Policy and the Imprint.
Which cookies & scripts and the associated processing of your personal data do you agree to?

You can change your selection anytime under Privacy Policy .