​You can apply for the Class I medical device listing under Hong Kong's Medical Device Administrative Control System (MDACS) through the Medical Device Information System (MDIS), the official online platform provided by the Hong Kong Department of Health.

​Applying for Class I medical device registration under Hong Kong's Medical Device Administrative Control System (MDACS) involves the following:

The device must be classified as Class I, which is the lowest risk category for medical devices under MDACS. These are typically non-invasive and simple devices with minimal risk to patients or users.

The Medical Device Administrative Control System (MDACS) in Hong Kong is a voluntary regulatory system designed to ensure the safety and performance of medical devices in the market. If you are looking to register a Class I medical device under MDACS, the following are the key steps and processes to follow:

​In Hong Kong, the Medical Device Administrative Control System (MDACS) provides a voluntary framework for the listing of medical devices, including Class I general medical devices. Class I devices are considered low-risk and are subject to less stringent regulatory controls. The MDACS aims to ensure the safety and performance of medical devices available in the market.​

The typical processing time to obtain registration for Class B medical devices with the Vietnam Ministry of Health (MOH) is:

No, Class B medical device registration with the Vietnam MOH does not require annual renewal.

The purpose of registering Class B medical devices with the Vietnam Ministry of Health (MOH) is to ensure that all medical devices entering the Vietnamese market are safe, effective, and of high quality, and to provide legal authorization for their import, distribution, and use in Vietnam.