🇭🇰 What is Class B Medical Device MDACS Registration in Hong Kong?The Medical Device Administrative Control System (MDACS) is a voluntary registration system implemented by the Medical Device Division (MDD) of Hong Kong’s Department of Health to regulate the safety and quality of medical devices in Hong Kong.

To register a Class B medical device under the Medical Device Administrative Control System (MDACS) in Hong Kong, follow the steps outlined by the Medical Device Division (MDD) of the Department of Health. While MDACS is voluntary, it is strongly recommended—especially for procurement by public healthcare institutions in Hong Kong.

The typical processing time to obtain Class B medical device registration under the Hong Kong MDACS is about 60 to 90 working days (approximately 3 to 4 months) after submitting a complete application.

No, Class B medical device registration under the Hong Kong MDACS does not require annual renewal.

The purpose of obtaining Class B medical device registration under the Hong Kong MDACS is to ensure that low-to-moderate risk medical devices meet the safety, quality, and performance standards required for marketing and use in Hong Kong. Specifically, it serves to:

After the 5-year validity, the registration must be renewed to remain valid for marketing and distribution in Hong Kong.

Classification Context:The Hong Kong Medical Device Administrative Control System (MDACS) classifies medical devices based on risk levels into Class A, B, C, and D — with Class A being the lowest risk and Class D the highest.

Ensure your medical device is classified as Class B based on MDACS guidelines.