In Vitro Diagnostic Device Manufacturing License

In Vitro Diagnostic Device Manufacturing License
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In India, the manufacturing and sale of In Vitro Diagnostic (IVD) devices are regulated by the Central Drugs Standard Control Organization (CDSCO) under the Medical Device Rules, 2017. If you intend to manufacture In Vitro Diagnostic devices in India, you will need to obtain a manufacturing license from the CDSCO. Here are the general steps involved:

 1. Establish a Business Entity:
– Set up a legal entity for your business. This may involve registering a company in India.

 2. Determine Device Classification:
– Classify your In Vitro Diagnostic device based on the risk associated with its use. Devices are categorized into Classes A, B, C, and D, with increasing levels of regulatory scrutiny.

 3. Appoint an Authorized Agent (if applicable):
– If the manufacturer is not based in India, it may be necessary to appoint an authorized agent in India to represent the manufacturer.

 4. Quality Management System (QMS):
– Implement a Quality Management System (QMS) in compliance with the relevant standards, such as ISO 13485. A QMS is a crucial aspect of obtaining a manufacturing license.

 5. Prepare Technical Documentation:
– Develop comprehensive technical documentation for your In Vitro Diagnostic device. This documentation should cover design, manufacturing processes, safety, and performance aspects.

 6. Conduct Regulatory Testing:
– Perform any necessary regulatory testing or studies required by the CDSCO to demonstrate the safety and efficacy of your device.

 7. Prepare for Inspections:
– Be prepared for inspections by CDSCO officials. They may visit your manufacturing facility to assess compliance with Good Manufacturing Practices (GMP). 8. Submit License Application:

– Prepare and submit the application for the manufacturing license to the CDSCO. Include all required documents, such as the technical dossier, proof of QMS implementation, and details of the manufacturing facility.

 9. Payment of Fees:
– Pay the applicable fees associated with the license application.

 10. Review and Evaluation:
– The CDSCO will review your application, conduct inspections, and evaluate the documentation. This process is to ensure that your manufacturing processes and devices comply with regulatory standards.

 11. License Issuance:
– If the CDSCO is satisfied with the application, they will issue a manufacturing license for your In Vitro Diagnostic device.

 12. Post-License Compliance

– Comply with any post-license requirements, including reporting changes in manufacturing processes or product specifications.

Keep in mind that this is a general overview, and the specific requirements may vary based on the class of the device and any updates to regulations. It is recommended to refer to the latest guidelines from the CDSCO and, if needed, consult with regulatory experts familiar with the Indian medical device regulatory landscape.

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