Import Registration for Class A Non-Sterile & Non-Measurable Devices

Imported Class A non-sterile and non-measurable medical devices fall under the simplified registration route on the SUGAM portal. Importers can register these items by submitting the foreign manufacturer's declarations and standard device specifications. We ensure your documentation matches CDSCO standards to enable instant portal downloads and avoid port-of-entry delays.

Key Benefits

  • Fast customs clearance alignment and port validation
  • No physical site inspection required for low-risk items
  • Highly affordable import entry route for global distributors

Recognized Standards

CDSCO
BIS
ISI

Our Methodology

1

Agent Portal Login

Access the importer's verified profile on the SUGAM portal.

2

Specification Upload

Input manufacturer names, product codes, and device catalogs.

3

Undertaking File

Upload compliance certificates and foreign manufacturer undertakings.

4

Download Registration

Retrieve and download the registration certificate instantly.

Required Documents

Certificate of ISO 13485
Free Sale Certificate from country of origin
Undertaking of Quality from foreign manufacturer

Common Questions

Need Assistance with Import Registration for Class A Non-Sterile & Non-Measurable Devices?

Our experts are ready to guide you through every step of the regulatory process. Let's discuss your project today.

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