FAQ’s on India Regulations

CDSCO Medical Device Registration India

The Central Drugs Standard Control Organization (CDSCO) is a national regulatory body that reports to the Directorate General of Health Services in the Ministry of Health and Family Welfare and regulates cosmetics, pharmaceuticals, and medical devices. The CDSCO headquarters are located at FDA Bhawan, Kotla Road, New Delhi 110002, and it has six zonal offices, four sub-zonal offices, thirteen port offices, and seven laboratories located throughout the country.

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There are various rules and compliances that must be followed in order to register a medical device under CDSCO in India. The plethora of procedures and demanding compliances may result in challenging inquiries that could perplex the user and hinder the registration process. Our experienced regulatory consultants provide comprehensive consulting services and help you navigate the Registration Application Submissions to CDSCO in a timely and effective manner.

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FAQ's

The Drugs & Cosmetics Act,1940 and rules 1945 have entrusted various responsibilities to central & state regulators for regulation of drugs, cosmetics & medical devices. The manufacturing, import, sale, and distribution of medical devices are regulated under this act.  Additionally, Medical devices are governed by the Medical Devices Rules 2017 (effective 1st Jan 2018),  Medical Devices (amendment) Rules 2020 (effective 1st Apr 2020) and amendments thereof.

With effect from 1st of Apr 2020 all medical devices have been notified vide a new & enlarged definition. This has been a major change since prior to this only 37 categories of medical devices were notified. The Medical Devices (amendment) Rules 2020 (effective 1st Apr 2020) details the roadmap for this transition.

Yes, SUGAM is the CDSCO official portal for online submission of applications.

Basis parameters specified in the Medical Devices Rules 2017, medical devices in India are classified as follows:

  • Class A – Low Risk
  • Class B – Low-moderate Risk
  • Class C – Moderate-high Risk
  • Class D – High Risk

Medical devices which were not notified prior to 1st Apr 2020 have been given a grace period of 18 months for registration/listing subsequently to be followed by an import/manufacturing licence.

Voluntary Registration Number is generated automatically on online submission of the prescribed documents for the same.

This would depend entirely on the device class, previous registration experience of the organization and readiness of their documentation. From our experience it may take anything from 2-4 months for document preparedness of an organisation as per CDSCO requirements.

Yes, we do. There are primarily two main dossiers to the prepared, the plant master file and the device master file. We have helped several organizations in the past to build such dossiers.

Depending on the backlog at CDSCO office it may take 4-6 months for the review of an application.

Sure, we would be glad to answer, do submit your request here in the contact us form.

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