The time frame for applying for Class IV medical device registration under Hong Kong’s MDACS (Medical Device Administrative Control System) varies based on several factors, including the complexity of the device, the completeness of the application, and whether any additional information is requested. Below is a general breakdown of the stages of review and the approximate time required for each.

Time Frame for Class IV Medical Device Registration

The entire process of Class IV medical device registration in Hong Kong typically takes between 6 to 12 months, depending on the factors mentioned above. Here’s a detailed breakdown:

1. Pre-Application Preparation (1 to 3 months):

• Prepare Documentation: Preparing the necessary documents (technical files, clinical data, ISO certifications, risk assessments, etc.) can take time, especially for high-risk devices.

• Appoint Authorized Representative (if applicable): If the manufacturer is overseas, appointing a local authorized representative and ensuring all documents are in order can add additional time.

• Compliance with Standards: Ensuring the device complies with applicable international standards (ISO, IEC, etc.) and gathering data on testing, biocompatibility, etc., may also require time.

2. Submission and Evaluation (3 to 6 months):

• Application Review: Once the application is submitted, the Hong Kong Department of Health will review the application. This involves checking for completeness, reviewing technical documentation, and verifying the device’s compliance with safety and performance standards.

  • The review time can vary depending on the complexity of the device and the volume of applications in the system at the time.

3. Request for Additional Information (2 to 3 months):

• Additional Information Request: If the Department of Health requires further details or clarification on the documentation, they will send a request. Manufacturers must respond promptly, which could extend the processing time.

4. Final Decision (1 to 2 months):

• Approval: If the device passes all evaluations, the registration will be granted.

• Certificate Issuance: Once approved, the registration certificate will be issued, and the device can be marketed in Hong Kong.

Stages of Review for Class IV Medical Device Registration

The review process consists of several stages that ensure the device meets safety, performance, and regulatory requirements.

1. Application Submission

• The manufacturer or their authorized representative submits the complete application, including technical documentation, clinical data, and any relevant certificates or reports.

2. Preliminary Evaluation

• The Hong Kong Department of Health conducts a preliminary evaluation to ensure that the application is complete. Incomplete applications may be returned to the applicant for additional information.

3. Technical Evaluation

• The technical evaluation is a detailed review of the documentation submitted. This includes an assessment of:

  • The safety and efficacy of the device

  • Compliance with ISO 13485 (Quality Management System)

  • Clinical evaluation and risk management procedures

  • Device labeling and instructions for use (IFU)

• For Class IV devices, the review process is more stringent and detailed, especially for high-risk devices like implantables or life-supporting devices.

4. Manufacturing Site Inspection (if applicable)

• If required, the Department of Health may request an inspection of the manufacturing facility to verify compliance with Good Manufacturing Practices (GMP) and other regulatory requirements. This inspection can add time to the review process.

5. Request for Additional Information

• The Department of Health may request further details or clarifications if they find gaps or issues in the initial submission. This could involve submitting additional test reports, risk management documents, or clarifications on labeling.

6. Final Review and Decision

• After reviewing all documentation, including any additional information submitted, the Department of Health will make a final decision.

• If the device meets all requirements, a medical device registration certificate will be issued.

Factors That Can Affect the Time Frame

• Completeness of the Application: Missing or incomplete documentation can delay the process, as the Department of Health will need to request further information.

• Complexity of the Device: The more complex the device (e.g., implantable or active devices), the more detailed the review process will be.

• Inspection of Manufacturing Site: If an inspection is required, this can add several weeks to the overall time.

• Adverse Issues or Non-Compliance: If the application does not meet the required standards, the process can take longer due to additional requests for clarification or re-submission of documents.

Summary of Time Frame for Class IV Medical Device Registration

• Pre-Application Preparation: 1 to 3 months

• Submission and Evaluation: 3 to 6 months

• Request for Additional Information (if applicable): 2 to 3 months

• Final Decision and Certificate Issuance: 1 to 2 months

Thus, the overall processing time can range from 6 to 12 months, depending on the specifics of the device and the application process.

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