Manufacturing Registration for Class A Non-Sterile & Non-Measurable Devices
Under the CDSCO Medical Device Rules, domestic manufacturers of low-risk Class A medical devices that are non-sterile and non-measurable must register their products and manufacturing sites through the SUGAM online portal. While this is a simplified self-declaration registration route compared to the MD-05 license, it requires precise classification, catalog entries, and legal undertakings. We help complete the process efficiently with zero errors.
Key Benefits
- Streamlined and rapid online registration process
- Instant generation of CDSCO file registration numbers
- Cost-effective compliance path for low-risk medical equipment
Recognized Standards
Our Methodology
Portal Setup
Create and verify your manufacturing company profile on the CDSCO SUGAM portal.
Technical Upload
Enter product descriptions, catalog numbers, raw material specs, and intended use.
Undertaking Submission
Upload signed declarations of compliance conforming to the medical device standards.
Registration Generation
Download the official CDSCO registration certificate instantly.
Required Documents
Common Questions
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