To apply for MDACS registration of Class III in vitro diagnostic medical devices in Hong Kong, the following conditions must be met:

1. Device Classification

• Ensure that the device is correctly classified as a Class III IVD. This classification is based on its intended use, risk level, and potential impact on health.

2. Compliance with Regulatory Standards

• The device must comply with relevant safety, quality, and performance standards as outlined by the Hong Kong Department of Health.

3. Quality Management System

• Applicants must have an established Quality Management System (QMS) that meets ISO 13485 or equivalent standards. This includes documentation and evidence of proper design, manufacturing, and post-market surveillance processes.

4. Comprehensive Documentation

• Prepare thorough documentation to support the application, including:
  • Technical file (product description, intended use, design, and manufacturing information).
  • Clinical data demonstrating safety and effectiveness.
  • Risk management plan identifying potential hazards and mitigation strategies.
  • Labeling and packaging information compliant with regulatory requirements.

5. Clinical Evidence

• Provide sufficient clinical evidence to demonstrate the safety and efficacy of the device. This may include results from clinical trials, performance studies, and any relevant scientific literature.

6. Adverse Event Reporting Procedures

• Establish procedures for monitoring and reporting adverse events related to the device once it is on the market.

7. Payment of Registration Fees

• Ensure payment of the required application fees, as specified by the Medical Device Control Office (MDCO).

8. Manufacturer and Distributor Compliance

• If the manufacturer is based outside Hong Kong, a local authorized representative must be designated to handle regulatory matters in Hong Kong.

9. Submission of Application

• Ensure that the application and all supporting documents are submitted in accordance with MDCO guidelines, either online or by mail.

10. Regulatory Updates

• Stay informed about any changes in regulations, guidelines, or procedures by regularly checking the MDCO website or consulting with regulatory experts.

Meeting these conditions will facilitate the application process for MDACS registration of Class III in vitro diagnostic medical devices in Hong Kong.

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