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What is India medical device rules
India represents a compelling market opportunity for global medical device manufacturers, with most 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. TÜV SÜD is a registered Notified Body authorised to test and certify medical devices according to medical device regulations in India.
TÜV SÜD South Asia Pvt. Ltd. is a registered Notified Body authorised to audit the manufacturer and submit the recommendation to authority according to medical device regulations in India.
Historically, medical devices in India have been mostly unregulated. That has changed in recent years. 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 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 their classification. New devices shall be added to this list by the 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 issuing of import license for all classes of medical devices, issue of manufacturing, loan license for Class C & Class D Medical Devices. SLA is responsible for issuing manufacturing and loan licenses for Class A & Class B Medical Devices, wholesale licenses for sale of medical devices.
SLA assigns a Notified Body to audit and 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 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 leads 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:
TÜV SÜD South Asia Pvt. Ltd. is a registered Notified Body authorised to audit the manufacturer and submit the recommendation to authority according to medical device regulations in India.
Historically, medical devices in India have been mostly unregulated. That has changed in recent years. 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 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 their classification. New devices shall be added to this list by the 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 issuing of import license for all classes of medical devices, issue of manufacturing, loan license for Class C & Class D Medical Devices. SLA is responsible for issuing manufacturing and loan licenses for Class A & Class B Medical Devices, wholesale licenses for sale of medical devices.
SLA assigns a Notified Body to audit and 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 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 leads 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:
How TÜV SÜD can help you with India medical device rules
TÜV SÜD South Asia Pvt. Ltd. experts have first-hand knowledge of current and prospective medical device regulations in India. We maintain effective communications with national regulators and representatives of international manufacturers.
In addition, our expertise in global technical and regulatory issues applicable to medical devices may ease the product approval process in India and other countries.
With a Regulatory Foreign Affairs and Clinical Centre of Excellence, we are recognised by regulatory authorities around the world for our extensive experience with all types of medical devices. We conduct quality management system certifications, audits and factory inspections according to international regulations and standards.
Our technical professionals are actively involved in international standards development activities related to medical devices and participate in several key standards committees.
Our regional medical health experts speak your local language and understand regional and India medical device regulation and knowledge needs.
What our India medical device rules service includes
- QMS Auditing & Technical review – 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 conduct 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 services – TÜV SÜD can also provide testing service related to biocompatibility, sterility, packaging, IEC 60601-1 & EMC which are independent of certification services.
