Licensing Authority
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:
- Manufacture for Class C and Class D devices
- Import of all classes of devices
- Clinical investigation and approval of investigational medical devices
- clinical performance evaluation and approval of new in vitro diagnostic medical devices and;
- co-ordination with the State Licensing Authorities
The State Licensing Authority will act as competent authority for enforcement of Indian Medical Device Rule 2017 and will be responsible for:
- Manufacture for sale or distribution of Class A or Class B medical devices;
- Sale, stock, exhibit or offer for sale or distribution of medical devices of all classes
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.
Minimum Requirements for Manufacturing License
For obtaining manufacturing license, the manufacturer of devices shall have proper documentation in place. The documentation shall consist of the following:
- 1.Quality Management System:
- The manufacturer of the devices shall comply to the requirements laid out in the fifth schedule i.e. Quality Management System for medical devices and in vitro diagnostic medical devices and shall have a documented QMS in place.
- 2.Plant Master File:
- A Plant Master File shall be prepared as per the requirements of Part III, Appendix I. The plant master file contains information on production and/or control of device manufacturing carried out at the premises.
- 3.Device Master File:
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:
- Device description,
- Design and Manufacturing Process,
- Design verification & validation reports,
- Essential Principles checklist,
- Risk analysis report,
- Clinical evaluation,
- Biocompatibility reports,
- Stability data,
- Sterilization validation reports and
- PMS data
Role of Maven Profcon Services LLP
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.
- Online registration on SUGAM Portal
- Documentation and Implementation of Quality Management System
- Preparation of Site Master File
- Compiling Technical Documentation
- Conducting Mock Audits
- Provide Audit Support
- Solve Queries and Non-Conformities
