Class II in vitro diagnostic (IVD) medical device registration in Hong Kong under the Medical Device Administrative Control System (MDACS) refers to the regulatory process for devices that pose a moderate level of risk to patients and users. This classification includes tests or devices that are used to diagnose diseases or conditions but require a more stringent evaluation compared to Class I devices.

Key Aspects:

1. Moderate Risk: Class II IVDs are considered to have a moderate potential risk, requiring thorough assessment to ensure safety and effectiveness.

2. Regulatory Requirements: Manufacturers must submit detailed technical documentation, including evidence of safety and performance, labeling information, and quality management system compliance (ISO 13485).

3. Review Process: The application undergoes a structured review by the Department of Health, including initial and technical evaluations, to assess compliance with relevant standards.

4. Market Access: Successful registration allows manufacturers to legally market their Class II IVDs in Hong Kong, contributing to public health and safety.

5. Post-Market Obligations: Registered devices must be monitored for performance and any adverse events after reaching the market, ensuring ongoing compliance with regulatory standards.

Summary

Class II IVD registration in Hong Kong signifies a regulatory framework for moderately risky diagnostic devices, requiring comprehensive documentation and evaluation to ensure safety and effectiveness before market access.

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