Obtaining MDACS (Medical Device Administrative Control System) registration for Class IV in vitro diagnostic (IVD) medical devices in Hong Kong involves a structured process. Here’s a step-by-step guide on how to navigate the registration process:

Step-by-Step Guide to Obtain MDACS Registration

1. Determine Device Classification:

   • Confirm that your device is classified as a Class IV IVD. Familiarize yourself with the classification criteria outlined in the Medical Device Ordinance (Cap. 663) to ensure compliance.

2. Prepare Technical Documentation:

   • Gather all necessary technical documents required for registration, including:
     • Device Description: Detailed information about the device, including its intended use, target population, and indications.
     • Manufacturing Information: Details about the manufacturing processes, quality control measures, and facilities.
     • Clinical Evaluation Data: Evidence supporting the safety and effectiveness of the device, which may include clinical trials or literature reviews.
     • Risk Management Documentation: Comprehensive risk assessments in accordance with ISO 14971.
     • Labeling and Instructions for Use (IFU): Clear and compliant labeling that outlines device use, warnings, and contraindications.
     • Quality Management System Documentation: Evidence of compliance with ISO 13485 or equivalent standards.

3. Implement a Quality Management System (QMS):

   • Ensure that your organization has an effective QMS in place, as this is critical for regulatory compliance and ongoing quality assurance.

4. Conduct Pre-Submission Review:

   • Review all documentation and processes for completeness and compliance with MDCO guidelines. Conduct internal audits if necessary to ensure readiness.

5. Submit Application:

   • Complete the MDACS registration application form and submit it to the Medical Device Control Office (MDCO) along with the following:
     • All required technical documentation.
     • Payment of the applicable application fees.

6. MDCO Review:

   • Upon submission, the MDCO will initiate a review process, which typically involves:
     • Initial screening of documents.
     • Detailed evaluation of technical documentation, clinical data, and risk management information.
     • Consultation with experts if necessary.

7. Respond to Queries:

   • If the MDCO requests additional information or clarification, provide prompt and thorough responses to facilitate the review process.

8. Approval Notification:

   • If the application is approved, the MDCO will issue a registration certificate, allowing you to market and distribute the device in Hong Kong.
   • The certificate may include specific conditions or requirements that must be adhered to post-registration.

9. Implement Post-Market Surveillance:

   • After obtaining registration, develop and implement a post-market surveillance plan to monitor the device's safety and effectiveness in the market.
   • Ensure procedures are in place for reporting adverse events and handling user feedback.

10. Maintain Ongoing Compliance:

    • Continuously monitor and comply with the regulatory requirements, including conducting periodic reviews, updates, and renewals as necessary.
    • Stay informed about any changes in regulations that may affect your device.

Summary

To obtain MDACS registration for Class IV IVD medical devices in Hong Kong, manufacturers must follow a systematic process that includes confirming device classification, preparing comprehensive technical documentation, submitting a complete application, and responding to regulatory inquiries. By adhering to these steps and maintaining ongoing compliance, manufacturers can successfully navigate the registration process and bring their devices to the market.

Contact Us：

Whatsapp or Wechat：+86 15816864648；email address：hito.lin@grzan.cn