MDACS registration stands for the Medical Device Administrative Control System, which regulates medical devices, including Class III in vitro diagnostic (IVD) devices, in Hong Kong. This registration ensures that devices meet safety, quality, and effectiveness standards.

To apply for MDACS registration for Class III IVDs, follow these steps:

1. Classification: Confirm your device's classification as Class III.
2. Documentation: Prepare necessary documents, including product descriptions, clinical data, quality management certifications, and labeling information.
3. Application Form: Complete the MDACS application form accurately.
4. Submission: Submit the application along with the required documents to the Medical Device Control Office (MDCO), either online or by mail.
5. Payment: Pay the applicable registration fees.
6. Review Process: The MDCO will review your application. Be ready to provide additional information if requested.
7. Approval: Upon approval, you’ll receive a registration certificate, allowing you to market your device.

Always check the MDCO website for the latest requirements and guidelines.

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