Class I IVD medical device registration under Hong Kong MDACS refers to the process of obtaining regulatory approval to market and sell Class I In Vitro Diagnostic (IVD) medical devices in Hong Kong. MDACS stands for the Medical Device Administrative Control System, which is the regulatory framework used by the Hong Kong Department of Health (DoH) to manage medical device registration, including IVD devices.

What is a Class I IVD Medical Device?

• Class I IVD devices are low-risk medical devices used for diagnostic purposes that are intended for in vitro use (i.e., outside the human body).
• These devices typically include simple, non-invasive diagnostic tools such as:
  • Blood glucose meters.
  • Pregnancy tests.
  • Urine test strips.

They are classified as low-risk due to their minimal potential to harm patients or users when used correctly.

Why Register Class I IVD Medical Devices?

The registration of Class I IVD devices under MDACS ensures that the devices meet the minimum safety, performance, and quality standards required for use in Hong Kong. It provides confidence to healthcare professionals and consumers that the device is safe and effective for its intended purpose.

Key Aspects of Class I IVD Medical Device Registration under MDACS:

1. Regulatory Approval: Manufacturers must submit an application to the Hong Kong Department of Health to obtain approval to market and sell their Class I IVD devices in Hong Kong.

2. Safety and Compliance: The registration process ensures that the device complies with safety and performance standards. Manufacturers must demonstrate that their devices meet international standards like ISO 13485 (Quality Management System) and ISO 14971 (Risk Management).

3. Simplified Process for Low-Risk Devices: Since Class I IVD devices are considered low-risk, the registration process is relatively straightforward compared to higher-class devices, requiring less extensive clinical data or testing.

4. Required Documentation: Manufacturers must provide detailed documentation about the device, including a description, labeling, risk assessment, performance data (if applicable), and details about the manufacturing process.

5. Regulatory Body: The Hong Kong Department of Health (DoH) manages the registration process under MDACS and is responsible for overseeing compliance and post-market surveillance.

6. Registration Number: Once the registration is approved, a registration number is issued, which must be displayed on the device packaging and labeling.

7. Post-Registration Obligations: After registration, the manufacturer must comply with post-market surveillance requirements, report adverse events, and renew the registration every 5 years.

In summary, Class I IVD medical device registration under Hong Kong MDACS is a regulatory process that allows manufacturers to market low-risk diagnostic devices in Hong Kong, ensuring that these devices meet safety and quality standards for patient and user protection.

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