Mandatory Documents for MD 5 Medical Device Manufacturing License for Class B Devices
The MD 5 License is issued by the State Licensing Authority (SAL). The SLA plays a pivotal role in upholding the safety and quality standards of medical devices available in the market. Prospective manufacturers are required to submit an application on Form MD 3 to the SLA to obtain approval of MD 5 Medical Device Manufacturing License.
The application, submitted using Form MD-3, must be accompanied by crucial documents to secure the Manufacturing License MD 5.
What are the mandatory documents to be submitted for MD 5 Manufacturing License along with the application MD 3?
Below is the list of mandatory documents to be submitted to the Licensing Authority to get MD 5 License to Manufacture Medical Devices in India.
- Covering Letter
- Constitution of the Firm
- Sale Deed / Rent Deed
- Plant Master File / Site Master File
- Device Master File
- Test License, if any
- Compliance with the provision of Fifth Schedule
Area You Searching for the Template of Device Master File and all Mandatory Documents for MD 5?
We have Customized Device Master File & All Essential Documents for MD 5 Medical Device Manufacturing License.
Device Master File consists of comprehensive information on the Medical Device from its initial stage up to its shelf life. The content of the Device Master File should be in accordance with Appendix II of Medical Device Rule, 2017. Below is a list of the mandatory requirements of the Device Master File.
- Executive Summary
- Device Description
- Product Specification, Including Variants and Accessories
- Reference to Predicate Device
- Labelling & Instructions for Use
- Device Design & Drawing
- Manufacturing Processes
- Essential Principles Checklist
- Risk Analysis and Control Summary
- Verification and Validation of the Medical Device
- Biocompatibility
- Medicinal Substances
- Biological Safety
- Sterilization Validation
- Software Verification and Validation
- Animal Studies
- Stability Data
- Clinical Evidence
- Post-Marketing Surveillance Data
- Batch Release Certificate
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