Determine Classification: Ensure that your device is correctly classified as Class III based on its intended use and risk profile.

Classification: Confirm your device's classification as Class III.

Determine Device Classification: Confirm that your IVD is classified as Class III based on its intended use and risk assessment.

Obtaining Class II in vitro diagnostic (IVD) medical device registration in Hong Kong under the Medical Device Administrative Control System (MDACS) typically takes about 3 to 6 months.

In Hong Kong, Class II in vitro diagnostic (IVD) medical devices registered under the Medical Device Administrative Control System (MDACS) are not subject to mandatory annual reviews. However, manufacturers are required to maintain ongoing compliance with regulatory standards and should be prepared for periodic audits or inspections by the authorities.

Registration allows manufacturers to legally market and distribute their devices in Hong Kong, ensuring compliance with local regulations.

The cycle for Class II in vitro diagnostic (IVD) medical device registration in Hong Kong under the Medical Device Administrative Control System (MDACS) typically takes about 3 to 6 months. The duration can vary based on several factors, including the complexity of the device, the completeness of the application, and the responsiveness of the applicant to any queries from the regulatory authorities.

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.