Navigating the Path to Obtaining a Medical Device Manufacturing License in India

Are you looking to venture into the medical device manufacturing industry in India? Understanding the regulatory landscape is crucial for success. Here's a concise guide on how to obtain a medical device manufacturing license in India.

Firstly, classify your medical device according to its risk level, as per the Medical Device Rules, 2017. Classify it into Class A, B, C, or D based on factors like intended use and invasiveness.

Step-by-Step Process:

1. Device Classification

Determine the risk classification of your medical device based on the Medical Device Rules, 2017.

2. Quality Management System

Implement a quality management system compliant with ISO 13485 standards.

3. Manufacturing License Application

Submit the manufacturing license application to the appropriate regulatory authority.

4. Facility Inspection

Undergo facility inspection by CDSCO officials to ensure compliance with manufacturing standards.

5. License Approval

Upon successful inspection and document verification, the manufacturing license is granted.

The process typically takes 3-6 months depending on the device classification and completeness of documentation.