FAQ’s on India Regulations

Q: What all medical devices are currently notified?

With effect from 1 st 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 1 st Apr 2020) details the roadmap for this transition.

Q: Which all medical devices require voluntary registration?

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

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.

Ensure hassle-free medical device registration with .

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.

With RSI, you can count on smooth stress-free registration of your medical devices in India!

FAQ's

Which is the nodal body in India for Medical Devices Registration?

The Central Drugs Standard Control Organization (CDSCO) under Directorate General of Health Services, Ministry of Health & Family Welfare, Government of India is the National Regulatory Authority (NRA) of India. It is headquartered in New Delhi and has six zonal offices spread across the country. The Drug Controller General of India (DCGI) is the nodal officer within the CDSCO.

What are the governing laws/acts for India regulations?

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 1^st Jan 2018), Medical Devices (amendment) Rules 2020 (effective 1^st Apr 2020) and amendments thereof.

What all medical devices are currently notified?

With effect from 1^st 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 1^st Apr 2020) details the roadmap for this transition.

What is the classification followed for Medical Devices in India?

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

What is the usual timeline for processing of an import/manufacturing application post submission?

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

Is there a portal for online submission of applications?

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

Do you also provide dossier making services?

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.

Which all medical devices require voluntary registration?

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

What services and approvals are currently available on the NSWS portal for the medical device industry?

The NSWS portal currently offers various central and state related approvals. For the most up-to-date information and new services, businesses are recommended to regularly visit the official NSWS portal.

How much time does it take for an organization to prepare the documents for import/manufacturing license application submission?

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.

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