Class IV medical device registration under Hong Kong's Medical Device Administrative Control System (MDACS) refers to the regulatory process for high-risk medical devices that require rigorous assessment and approval before they can be marketed in Hong Kong.

Class IV Medical Devices:

Class IV devices are the highest-risk category of medical devices under the MDACS. These devices generally have the potential to cause significant harm to patients or users if they fail or malfunction. They include:

• Implantable devices (e.g., pacemakers, artificial joints)

• Life-supporting or life-sustaining devices (e.g., ventilators, dialysis machines)

• Devices with a high level of risk to health, such as diagnostic devices used for critical health conditions.

Given the high risks associated with these devices, Class IV medical devices are subjected to the most stringent regulatory requirements under MDACS.

Purpose of Registration:

The registration process ensures that these devices meet the safety, quality, and effectiveness standards required for public health protection. It involves a thorough review of technical documentation, clinical data, and manufacturing practices to confirm the device is safe and effective for its intended use.

Why It’s Important:

• Patient Safety: Class IV devices directly impact patient health, so their safety, efficacy, and reliability are critical.

• Regulatory Compliance: Manufacturers must comply with the MDACS requirements to legally market and distribute their devices in Hong Kong.

• Market Access: Only registered Class IV devices can be sold in Hong Kong, ensuring that products meet the necessary standards.

Key Steps in the Registration Process:

• Documentation Submission: Manufacturers must submit comprehensive documentation including clinical trial results, safety data, risk assessments, and evidence of compliance with relevant international standards (e.g., ISO 13485, ISO 14971).

• Evaluation: The Hong Kong Department of Health reviews the documentation to ensure compliance with regulatory standards.

• Approval: If the device meets all safety and effectiveness requirements, it is granted approval and registered under MDACS, allowing it to be marketed in Hong Kong.

Class IV medical device registration is a critical step to ensure that high-risk medical devices are safe, effective, and ready for use in the healthcare setting in Hong Kong.

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