To apply for Class C medical device registration under Hong Kong’s Medical Device Administrative Control System (MDACS), you need to follow a structured process and submit your application to the Medical Device Control Office (MDCO). Here’s a detailed guide on how and where to apply.

To register a Class C medical device under Hong Kong’s Medical Device Administrative Control System (MDACS), the application must include a range of documents that demonstrate the device’s safety, quality, and performance. These documents must provide evidence of compliance with internationally recognized standards, risk management protocols, and regulatory requirements.

The process of registering a Class C medical device under Hong Kong’s Medical Device Administrative Control System (MDACS) is aimed at ensuring that medium-high risk devices meet essential safety and performance standards before being used in healthcare settings. Here’s a breakdown of the process, required documents, and important considerations for successfully completing this registration.

To register and apply for Class C medical device registration under Hong Kong’s Medical Device Administrative Control System (MDACS), you must submit your application to the Medical Device Control Office (MDCO), which operates under the Department of Health in Hong Kong.

The cost and time required to apply for Class C medical device registration under Hong Kong’s Medical Device Administrative Control System (MDACS) can vary depending on several factors such as the completeness of the application, the complexity of the device, and the applicant's readiness.

To handle Class C medical device registration under Hong Kong's Medical Device Administrative Control System (MDACS), you need to meet several specific requirements to demonstrate that your device is safe, effective, and of good quality. Class C devices are considered medium-high risk, so the documentation and compliance needed are more rigorous than for lower-risk devices.

The process of registering a Class C medical device under the Medical Device Administrative Control System (MDACS) in Hong Kong involves several key steps. Class C devices are considered medium-high risk, and the registration process ensures that these devices meet the necessary safety and performance requirements before being marketed in Hong Kong.

Class C medical devices are categorized as medium-high risk devices under the Medical Device Administrative Control System (MDACS) in Hong Kong. These devices are subject to more stringent regulatory control compared to lower-class devices, given their potential impact on patient health. Examples of Class C devices include surgical lasers, long-term implantable devices, and infusion pumps.