Healthcare & Pharma
Medical Device Manufacturing Licence
Indian manufacturers of medical devices are required to obtain manufacturing licences from CDSCO under the Medical Devices Rules, 2017. We assist with regulatory eligibility assessment, documentation, application preparation, CDSCO submissions and coordination throughout the licensing process for all device classes.
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- Regulatory eligibility and classification assessment
- MD-3/5 (Class A & B) or MD-7/9 (Class C & D) application support
- Technical and supporting documentation preparation
- CDSCO application filing and coordination
- Regulatory query management
- Licence renewal and post-licence compliance
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