Regulation of Medical Devices in India

Understanding the regulatory requirements for medical devices in India

India represents a compelling market opportunity for global medical device manufacturers, with the majority of medical devices sold in India imported from other countries. Substantial growth for the Indian medical device industry is expected to be driven by the current low per person spending rate for medical devices.

Regulatory landscape for medical devices in India

Historically, medical devices in India have been mostly unregulated. That has changed in recent year. Ministry of Health and Family Welfare Notification No. G.S.R, 78(E) dated 31st January 2017 notifies Medical Devices Rules 2017, has come into force with effect from 1st January 2018.

As of now the devices stated in the link are the regulated medical devices and in vitro diagnostic devices along with its classification. New devices shall be added to this list by Ministry of Health and Family Welfare from time to time. This can be identified in the link here.

India’s Central Drug Standard Control Organisation (CDSCO) has Central Licensing Authority (CLA) and State Licensing Authority (SLA) with responsibility for Licensing to Import, Manufacture for sale or for distribution and sale, stock, exhibit or offer for sale. CLA is responsible for all Import Devices Licensing and Class C & Class D Medical Devices Manufacturing, Loan and Wholesale Licenses. SLA is responsible for Class A & Class B Medical Devices Manufacturing, Loan and Wholesale Licenses.

SLA assigns a Notified Body to confirm the requirements of Quality Management System and Technical Review for Class A & Class B Medical Device Manufacturers. CLA may avail the services of a Notified Body for inspecting the manufacturing site of Class C and Class D medical devices and Technical Review. TÜV SÜD South Asia is a registered Notified Body with CDSCO under provisions Medical Device Rules 2017 to carry out audit of manufacturing site under the provision of said rules.

Regulated medical devices imported from outside of India that have obtained prior approval in the U.S., the European Union (EU), Canada, Japan or Australia may legally be sold in India by submitting the application and getting necessary license which lead to limited conformity assessment process. In such cases, device registration applicants must submit all documentation used in support of prior approvals with their application. Foreign manufacturers must also appoint an importer holding a valid wholesale license, and who is responsible for submitting a device registration application and dossier to the CLA

The following flow charts depict the steps involved in the licensing.

To Import Medical Devices

To Manufacture Medical Devices for Sale or for Distribution

Why choose TÜV SÜD

TÜV SÜD Product Service experts have first-hand knowledge about current and prospective regulations affecting medical device access to the Indian market, and maintain effective communications with national regulators and representatives of international manufacturers. In addition, TÜV SÜD Product Service’s expertise in global technical and regulatory issues applicable to medical devices can ease the product approval process and India and other countries. 

Our services at a glance

• Product safety testing and certification - TÜV SÜD Product Service is an EU Notified Body for medical devices, and is recognised by other regulatory agencies throughout the world for its extensive experience with a broad range of medical devices.
• Risk management expertise - TÜV SÜD experts have extensive experience in every aspect of risk management systems for medical device manufacturers in accordance with ISO 14971 and conducts thousands of in-depth risk management audits each year.
• GLP compliant biocompatibility evaluations - TÜV SÜD laboratories conducts biocompatibility tests in compliance with GLP Principles.
• Other testing and certification services - TÜV SÜD Product Service can also provide compliance testing for medical devices in accordance with other relevant regulations and standards, including IEC 60601-1 and electromagnetic compatibility (EMC).

Your benefits at a glance

• Recognised medical device expertise - TÜV SÜD Product Service is the largest EU Notified Body in the world. With a Regulatory Foreign Affairs and Clinical Centre of Excellence, TÜV SÜD Product Service is recognised by regulatory authorities around the world for its extensive experience with all types of medical devices.
• Quality system certification and auditing expertise - Medical device approvals often require the implementation of a quality management system. TÜV SÜD conducts quality management system certifications, audits and factory inspections consistent with most international regulations and standards, allowing clients to enjoy the benefits of coordinated inspections and audits, while reducing downtime and costs.
• Active involvement in standards development and implementation - TÜV SÜD Product Service technical professionals are actively involved in international standards development activities related to medical devices, and participate in a number of key standards committees. TÜV SÜD Product Service is also a member of Team NB, the European Association for Medical Devices of Notified Bodies, which facilitates the exchange of information on standards and regulations applicable to medical devices.
• Regional and local proficiency - Our regional medical health experts speak your local language and understand regional and local regulations and knowledge needs.
• Single source solution - TÜV SÜD offers testing services for major medical device markets according to international standards and regulations