The Indian Regulatory Body, Central Drugs Standard Control Organization, commonly known as CDSCO is responsible for the control of drugs and medical devices placed on Indian Market. The government of India has published the medical device rules, 2017, which came into effect from 1st January, 2018.
Under these rules, the manufacturers and importers of devices are required to obtain license which is valid until suspended or cancelled.
CDSCO has Central Licensing Authority (CLA) and State Licensing Authority (SLA).
The CLA is responsible for enforcement of Indian Medical Device Rule 2017, relating to:
The State Licensing Authority will act as competent authority for enforcement of Indian Medical Device Rule 2017 and will be responsible for:
The SLA shall assign a Notified body for the assessment of the quality management system and technical documentation for Class A and B Medical Devices. The CLA however may avail the services of Notified body for the assessment of technical documentation for Class C and D medical devices.
For obtaining manufacturing license, the manufacturer of devices shall have proper documentation in place. The documentation shall consist of the following:
A Device Master File shall be prepared as per the requirements of Part III, Appendix I. The Device Master File shall be prepared for each device or device category and includes the following:
Maven Profcon Services LLP, has a team of competent and expert personnel who can help you with the following activities and expediting the process for obtaining the license.