Class I medical device MDACS registration in Hong Kong refers to the process by which medical devices classified as Class I (low-risk devices) are registered with the Department of Health (DH) under the Medical Device Administrative Control System (MDACS). This registration allows the manufacturer or distributor to legally market and sell the device in Hong Kong, ensuring that it complies with the relevant regulatory standards for safety, performance, and quality.

Here’s what it means in detail:

Class I Medical Devices

• Class I devices are considered low-risk medical devices. These typically include non-invasive or minimally invasive products that do not pose significant risks to patients or users.

• Examples of Class I medical devices include bandages, thermometers, stethoscopes, non-invasive diagnostic devices, and other simple instruments.

• Class I devices are generally self-declared by the manufacturer, meaning they don't require pre-market approval or clinical trials, but must still meet regulatory safety and performance standards.

MDACS Registration

• MDACS (Medical Device Administrative Control System) is the regulatory framework set up by the Hong Kong Department of Health to manage the approval and oversight of medical devices in Hong Kong.

• MDACS registration involves the process of submitting an application to the Department of Health to register the device, ensuring it meets safety, quality, and risk management standards.

• Although Class I devices do not require extensive pre-market testing or clinical data, they still need to comply with relevant regulations and must be registered before they can be legally marketed in Hong Kong.

Why is MDACS Registration Important?

• Legal Requirement: It is a legal requirement for medical devices to be registered under MDACS before being sold in Hong Kong. This ensures that all medical devices available on the market have been assessed for safety and performance.

• Safety and Quality: The MDACS registration process ensures that devices meet Hong Kong's safety, efficacy, and quality standards.

• Market Access: Obtaining MDACS registration allows manufacturers and distributors to legally market their devices in Hong Kong, ensuring access to the market.

What Does the MDACS Registration Process Involve?

• Documentation: Manufacturers must submit necessary documents including product descriptions, risk management files, quality standards (ISO certifications, etc.), and labeling details.

• Review by DH: The Department of Health (DH) will review the submitted documentation to verify the device's compliance with Hong Kong’s medical device regulations.

• Issuance of Registration: If the DH is satisfied with the application, the device will be registered, and the manufacturer can legally sell it in Hong Kong.

• Post-Market Surveillance: Once the device is registered, manufacturers must continue to monitor its safety and performance and report any adverse events or changes to the device to the DH.

In summary, Class I medical device MDACS registration in Hong Kong is the process through which low-risk medical devices are registered with the Department of Health to ensure they meet the necessary regulatory standards before being marketed in the territory.

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