The procedures and steps for Class IV medical device registration under Hong Kong’s Medical Device Administrative Control System (MDACS) are clearly structured but voluntary (as of now), managed by the Medical Device Division (MDD) of the Department of Health. Class IV devices are high-risk devices such as implantable or life-supporting medical devices.

Under the Medical Device Administrative Control System (MDACS) managed by Hong Kong's Medical Device Division (MDD), Class IV medical devices are classified as the highest-risk devices. These are typically life-sustaining, life-supporting, or implanted devices, such as:

Hong Kong operates a voluntary listing scheme under MDACS (not mandatory yet, unless for public hospital procurement). However, registration is recommended for market acceptance and public tenders.

The typical timeline for obtaining Class III medical device MDACS registration in Hong Kong is approximately 12 weeks from the date of submission, assuming that the application is complete and there are no significant issues during the review process. Here's a breakdown of the steps involved and the corresponding timelines:

No, Class III medical device MDACS registration in Hong Kong does not require an annual review. However, the registration is subject to certain renewal and ongoing compliance obligations:

The purpose of obtaining Class III medical device MDACS registration in Hong Kong is to ensure that high-risk medical devices meet the required safety, effectiveness, and quality standards before they are marketed and used in the region. This process serves several important objectives, including:

Preparation Time: Applicants should allocate sufficient time to gather and prepare all necessary documentation, including technical files, clinical data, and quality management system certifications.

Class III medical device MDACS registration in Hong Kong refers to the process through which high-risk medical devices are registered with the Department of Health (DoH) under the Medical Device Administrative Control System (MDACS). It is part of Hong Kong's regulatory framework to ensure that medical devices sold in the region meet appropriate safety, efficacy, and quality standards.