Registering medical devices: a step-by-step guide

Introduction

Registering medical equipment and devices in Uzbekistan follows a different procedure than medicines.

Key requirements

Products are divided into categories based on risk level, with separate requirements set for each.

Required documents

• Technical file
• Quality certificate (ISO 13485)
• User manual
• Clinical evaluation report (if required)

Process steps

1. Step 1: Determine the category
2. Step 2: Submit technical documentation
3. Step 3: Review and registration

Conclusion

Correct classification significantly speeds up the process.