The cost and time required to register Class II in vitro diagnostic (IVD) medical devices in Hong Kong under the Medical Device Administrative Control System (MDACS) can vary based on several factors.

Registering Class II in vitro diagnostic (IVD) medical devices in Hong Kong under the Medical Device Administrative Control System (MDACS) involves meeting several specific requirements to ensure that the devices are safe, effective, and of high quality.

Registering Class II in vitro diagnostic (IVD) medical devices in Hong Kong under the Medical Device Administrative Control System (MDACS) involves several key processes and steps.

The registration of Class II in vitro diagnostic (IVD) medical devices in Hong Kong under the Medical Device Administrative Control System (MDACS) involves a structured process to ensure that these devices meet safety, effectiveness, and quality standards.

Familiarize yourself with the Medical Device Ordinance (Cap. 663) and the relevant guidelines for IVDs issued by the Department of Health (DH) in Hong Kong.

The time it takes to obtain Class D medical device registration under the Hong Kong Medical Device Administrative Control System (MDACS) can vary based on several factors, including the complexity of the device, the completeness of the application, and the regulatory workload.

Under the Hong Kong Medical Device Administrative Control System (MDACS), annual reviews are not specifically required for Class D medical device registration.

Obtaining Class D medical device registration under the Hong Kong Medical Device Administrative Control System (MDACS) offers several significant benefits for manufacturers and stakeholders in the medical device industry.