Medical Device manufacturing approval in India
As mentioned in our previous pages, the medical devices covered under Notified Medical Devices falls under Schedule M 111, needs Approval / License to start manufacturing in India.
We provide complete solutions to set up new facility and or upgrading the existing manufacturing facilities in compliance with Schedule M 111
We “one stop regulatory consulting shop” for medical device industries!!! Our experienced professionals guide you the following steps.
- We approve your Land and Building, if it is suitable for medical device manufacturing as per regulatory norms
- We design the facility after understanding your process and future expansion possibilities.
- We prepare the room book which clearly explains what/ how to arrange each process areas
- Support for validations and calibrations
- Proper guidance about and when to take plan approval from authorities
- Validation and Calibrations. (In-house and Supplied Goods)
- We prepare Site Master File with complete annexure
- GMP Training
- Support for preparing Department Manuals, SOPs, Work Instructions, Formats, reports
- Coordination with Inspectors
Step by step process
More details about clean rooms
If you are planning to set up new plant or renovating the existing facility, you are visiting the most eligible company’s web site.
Kindly contact us for more information about our services and regulatory requirements.