To register and apply for Class III medical device MDACS registration in Hong Kong, you must follow a well-structured process governed by the Department of Health (DoH) under the Medical Device Administrative Control System (MDACS). Here’s a step-by-step guide to help you navigate the process:

First, verify that your medical device qualifies as a Class III medical device under Hong Kong regulations. Class III devices are considered high-risk and require extensive regulatory oversight.

Handling the Class III medical device MDACS registration in Hong Kong requires careful preparation, compliance with local regulations, and following a structured application process. Here’s a step-by-step guide on how to handle the MDACS registration for Class III medical devices:

The application timeline for Class III medical device MDACS registration in Hong Kong can vary depending on several factors, including the completeness of your application and the complexity of the device. Below is an overview of the typical timeline and the stages of the review process for Class III medical device registration under the Medical Device Administrative Control System (MDACS):

The process for Class III medical device MDACS registration in Hong Kong involves several key steps, including ensuring compliance with local regulations, preparing necessary documentation, submitting the application to the Department of Health (DoH), and undergoing review. Here’s a detailed breakdown of the process and steps for Class III medical device registration under the Medical Device Administrative Control System (MDACS) in Hong Kong:

In Hong Kong, maintaining Class III medical device MDACS registration involves periodic updates to ensure continued compliance with the Medical Device Administrative Control System (MDACS). The process includes updates to the device’s registration, changes to its technical documentation, and submission of necessary reports.

After obtaining Class III medical device MDACS registration in Hong Kong, there are several ongoing regulatory requirements and responsibilities that must be adhered to in order to maintain compliance and ensure the safety and performance of your medical device in the market. Below are the key regulations and requirements that must be followed:

Before applying for Class III medical device MDACS registration in Hong Kong, proper preparation is key to ensuring that your application meets all the regulatory requirements and facilitates a smooth registration process. Below are the essential steps and considerations for preparing for the application: