For Class B medical device registration under Hong Kong MDACS, the applicable standards generally align with internationally recognized safety, performance, and quality standards. These standards help ensure that your device is safe and effective for use.

For Class B medical device registration under Hong Kong MDACS, the technical documentation you need to prepare is essential to demonstrate that your device is safe, effective, and complies with applicable standards. Here are the typical technical documentation requirements:

The processing time for Class B medical device registration under the Hong Kong Medical Device Administrative Control System (MDACS) typically ranges from 3 to 6 months. This timeframe depends on factors such as the completeness of your application, the complexity of the device, and the volume of applications being processed by the Medical Device Division (MDD) at the Department of Health.

he medical device must be correctly classified as Class B (low-to-medium risk) according to the MDACS classification rules.

The LRP must be a legal entity based in Hong Kong.

To register a Class B medical device under the Hong Kong MDACS (Medical Device Administrative Control System), you must prepare a detailed set of documents that demonstrate the safety, quality, and performance of the product. Below is a full list of required documents and guidance on how to prepare them.

Here is a comprehensive guide to the process, required documents, and key precautions for Class B medical device registration under the Hong Kong MDACS (Medical Device Administrative Control System):

To apply for Class B medical device registration under the Hong Kong MDACS (Medical Device Administrative Control System), you must submit the application to the Medical Device Division (MDD) of the Department of Health, Hong Kong SAR.