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.

What Does Class III Mean?

Class III medical devices are considered high-risk devices. They typically involve implantable devices, life-sustaining devices, or those that, if they fail, can cause serious harm to patients. These devices require the most rigorous regulatory oversight compared to lower-class devices.

Examples of Class III medical devices include:

• Implantable devices such as pacemakers and artificial joints.

• Life-supporting devices like ventilators and infusion pumps.

• Diagnostic devices that are used to monitor critical conditions.

Purpose of MDACS Registration:

MDACS registration ensures that these medical devices meet safety, quality, and performance standards before being allowed for sale and use in Hong Kong. The registration process involves a comprehensive review of various technical documents, clinical data, and compliance with international standards to protect public health and ensure patient safety.

MDACS Registration Process:

The MDACS registration process for Class III devices is thorough and requires the submission of extensive documentation to demonstrate the device’s safety, quality, and effectiveness. This includes technical data, clinical trial results, risk management reports, and compliance with ISO standards such as ISO 13485 (Quality Management System) and ISO 14971 (Risk Management).

Key Features of Class III MDACS Registration in Hong Kong:

• Rigorous Evaluation: Class III devices undergo a high-level review by the DoH, which involves assessing clinical data, risk assessments, and the manufacturer’s adherence to international standards.

• Post-Market Surveillance: After approval, manufacturers must monitor the performance of the device on the market and report any adverse events or device malfunctions.

• Renewal: Class III device registrations are typically valid for 5 years before requiring renewal.

The purpose of this registration process is to ensure that only safe, effective, and high-quality medical devices are allowed for use in Hong Kong, protecting public health and patient safety.

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