The application timeline for Class III medical device MDACS registration in Hong Kong can vary depending on several factors, including the completeness of your application and the complexity of the device. Below is an overview of the typical timeline and the stages of the review process for Class III medical device registration under the Medical Device Administrative Control System (MDACS):

1. Application Preparation

Timeframe: Several weeks to a few months (varies depending on the complexity of the device and availability of documentation)

• Before submitting the application, ensure you have gathered all the necessary documentation, including clinical data, technical files, ISO 13485 certification, and manufacturing information.

• If you're outside of Hong Kong, ensure you have appointed an authorized representative in Hong Kong.

2. Submission of Application

Timeframe: Immediate (application submission can be done once all documents are ready)

• After preparing all the required documentation, you can submit the MDACS application through the Department of Health’s MDACS online portal.

• The system will automatically generate a reference number upon submission, confirming the receipt of your application.

3. Review and Evaluation by the Department of Health (DoH)

Timeframe: 2 to 6 months, depending on the complexity of the device

• The DoH reviews the submitted application, which involves evaluating the safety, efficacy, and quality of the device, as well as ensuring compliance with Hong Kong’s medical device regulations.

Stages of the Review Process:

Stage 1: Initial Document Review

• Timeline: Typically 2-3 weeks after submission

• The DoH will check that the application is complete and verify that all required documents are included (technical documentation, clinical evaluation, labeling, etc.).

• If anything is missing or unclear, the DoH may request additional information.

Stage 2: Evaluation of Clinical and Technical Documentation

• Timeline: 1-3 months (depending on the complexity of the device)

• In this stage, the DoH evaluates the clinical data, risk management files, and other technical documentation provided in the application.

• The evaluation includes reviewing the clinical trials, post-market surveillance plans, and compliance with relevant international standards (e.g., ISO 13485, ISO 14971).

Stage 3: Request for Additional Information (if needed)

• Timeline: Varies (can add several weeks to the process)

• If the DoH identifies any issues or missing information, they may request clarification or additional documentation.

• The applicant must respond to these requests in a timely manner to avoid delays.

Stage 4: Final Decision and Issuance of Registration Certificate

• Timeline: After all information has been reviewed, it may take a few weeks for the DoH to make a final decision.

• If the application meets all requirements, the DoH will issue the registration certificate for the Class III medical device, allowing it to be sold and marketed in Hong Kong.

4. Post-Approval Monitoring

Timeframe: Ongoing after registration is granted

• After registration is granted, the DoH will continue to monitor the device through post-market surveillance.

• You are required to report adverse events and submit annual updates or renewal applications before the registration expires (usually in 5 years).

Total Estimated Timeline for Class III MDACS Registration:

• Preparation Time: Varies depending on the readiness of documentation (can take several weeks to months).

• Review and Approval Process: Typically 2 to 6 months, though it can vary depending on the complexity of the device and completeness of the application.

• Post-Approval Monitoring: Ongoing.

Factors that May Affect the Timeline:

1. Completeness of the Application: Missing or incomplete documents can delay the review process.

2. Device Complexity: Highly complex or innovative devices may take longer for evaluation.

3. Request for Additional Information: If the DoH requires additional information or clarification, this may extend the review timeline.

4. Authorized Representative: If you don’t have a local authorized representative in Hong Kong, it may take longer to coordinate and submit the application.

Contact Us：

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