Class C medical device registration under the Hong Kong Medical Device Administrative Control System (MDACS) refers to the regulatory framework for moderately to highly risky medical devices. Here's a detailed explanation of what it entails:

Definition of Class C Medical Devices

Class C Medical Devices are categorized as those that present moderate to high risks to patients and users. These devices typically require more stringent regulatory controls and evidence of safety and efficacy due to their potential impact on health. Examples may include:

• Implantable devices (e.g., pacemakers)
• Advanced diagnostic devices
• Devices used in surgical procedures that carry a higher risk

Regulatory Framework of MDACS

The Medical Device Control Office (MDCO) in Hong Kong oversees the registration of medical devices, including Class C devices, under the MDACS. The system aims to ensure that medical devices available in the market meet safety, quality, and performance standards, thereby protecting public health.

Key Aspects of Class C Registration

1. Risk Assessment:

   • Class C devices undergo rigorous risk assessments to evaluate potential hazards associated with their use. This assessment is usually documented through a Risk Management Report in accordance with ISO 14971.

2. Technical Documentation:

   • Manufacturers must submit comprehensive technical documentation, demonstrating compliance with safety and performance standards. This includes clinical evidence, quality management system compliance, labeling, and instructions for use.

3. Local Authorized Representative (LAR):

   • For manufacturers based outside Hong Kong, appointing a Local Authorized Representative is necessary. The LAR acts as a liaison between the manufacturer and the MDCO.

4. Clinical Evidence:

   • Devices classified as Class C typically require robust clinical data to support claims of safety and efficacy. This data can be derived from clinical trials, literature reviews, or post-market surveillance.

5. Post-Market Surveillance (PMS):

   • After registration, ongoing monitoring of the device’s safety and performance in the market is mandated. Manufacturers must implement a PMS plan to identify any potential risks associated with the device once it is in use.

6. Periodic Reporting:

   • Manufacturers must submit periodic safety update reports (PSURs) and report any adverse events related to the device to the MDCO.

Importance of Class C Registration

The registration of Class C medical devices under the MDACS is crucial for:

• Public Safety: Ensuring that devices meet necessary safety and performance standards to protect patients and healthcare providers.
• Market Confidence: Providing assurance to healthcare professionals and patients that the devices are safe and effective.
• Regulatory Compliance: Helping manufacturers comply with local laws and regulations, thereby facilitating smoother entry into the Hong Kong market.

In summary, Class C medical device registration under Hong Kong MDACS is a vital regulatory process designed to ensure the safety and efficacy of medical devices that present moderate to high risks. It involves rigorous assessment, documentation, and post-market monitoring to protect public health.

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