Once a Class III medical device has been successfully registered under the MDACS (Medical Device Administrative Control System) in Hong Kong, several important considerations and obligations remain. These are crucial for ensuring ongoing compliance with local regulations and maintaining the device’s legal status in the market.

For Class III medical device MDACS registration in Hong Kong, there are several key international standards and regulatory requirements that the medical device must comply with. These standards ensure the safety, performance, and quality of the device throughout its lifecycle—from development to post-market surveillance.Here’s a summary of the main standards that apply:

For Class III medical device MDACS registration in Hong Kong, a comprehensive set of technical documentation is required. This documentation is essential to demonstrate that the device meets the regulatory and safety standards outlined by the Medical Device Division (MDD) of the Hong Kong Department of Health.

Completeness of Application: If all documents are correctly completed and provided, the review process is faster. Incomplete or incorrect submissions can delay the process.

To apply for Class III medical device MDACS registration in Hong Kong, certain conditions must be met. These conditions ensure the device complies with the requirements for high-risk medical devices and that all regulatory processes are in place. Below are the key conditions that must be fulfilled:

Ensure your device qualifies as Class III (high-risk medical device) as per MDACS guidelines.

To register a Class III medical device under MDACS (Medical Device Administrative Control System) in Hong Kong, a structured set of documents is required. Below is a complete breakdown of the required documents and how to prepare the application files.

Here is a complete guide outlining the process, required documents, and key considerations for registering a Class III medical device under the Medical Device Administrative Control System (MDACS) in Hong Kong: