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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 upcoming regulatory guidelines issued by CDSCO for medical devices.

 

NOTIFIED BODY FOR MEDICAL DEVICES IN INDIA

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.

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. Zenith Quality Assessors Pvt. Ltd. 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:

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+91 9607006692 / 6823 / 6973 / 6945 / 4749

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Zenith Quality Assessors Pvt. Ltd. operates quality management system certification schemes, product certification schemes and testing activities under internally designated business divisions

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