CDSCO License services

If you are a manufacturer or importer of medical devices in India, obtaining the CDSCO license is a crucial step to sell your devices in India by complying with the regulatory requirements. At 60601Consult, we provide you with services to gain CDSCO license with ease.

Here’s the list of CDSCO certification services which you can pick and choose from:

  • Classification according to CDSCO guidelines for medical devices.

  • Preparation of technical documentation, including risk assessments, clinical data, and labeling requirements.

  • Assistance with submission of the CDSCO application and tracking progress through the review process

  • Establishing/reviewing ISO 13485 Quality management system which is the cornerstone of CDSCO certification for your manufacturing facility.

  • Evaluation of technical documentation and addressing any deficiencies or requests for additional information

  • Issuance of the CDSCO certificate of compliance from SLA,CLA or NABCB notified body once all requirements are met

  • Assistance with post-market surveillance and reporting requirements to maintain compliance over time

Our services are designed to help you achieve compliance with the Indian regulatory requirements efficiently and effectively. We work closely with you to ensure that your medical device meets all the necessary standards and requirements, allowing you to focus on your core business activities.

In summary, 60601Consult provides CDSCO certification services for medical devices in India, helping you achieve compliance with the regulatory requirements efficiently and effectively. Contact us today to learn more about our services and how we can assist you in obtaining the CDSCO certification for your medical devices.

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