The time required to obtain Class C medical device registration under the Hong Kong Medical Device Administrative Control System (MDACS) can vary based on several factors, including the complexity of the device, the completeness of the submitted documentation, and the efficiency of the review process. Here’s a breakdown of the typical timeline:

1. Preparation Phase

• Duration: Several weeks to months.
  • Manufacturers need time to prepare the necessary technical documentation, risk assessments, clinical evidence, and other supporting materials before submission.

2. Preliminary Review by MDCO

• Duration: About 1 to 2 months.
  • After submission, the Medical Device Control Office (MDCO) conducts an initial screening to ensure that the application is complete and all required documents are included.

3. In-Depth Technical Review

• Duration: Approximately 3 to 6 months.
  • Following the preliminary review, MDCO will carry out a comprehensive evaluation of the technical documentation. This phase may vary depending on:
    • The complexity of the device.
    • The thoroughness of the submitted data.
    • The need for additional information or clarification from the manufacturer.

4. Review of Post-Market Surveillance (PMS) Plan

• Duration: This review is typically included within the technical review phase. However, it may extend the total duration if significant revisions are needed.

5. Final Decision and Issuance of Registration

• Duration: Additional 1 to 2 months.
  • After completing the technical review, MDCO will make a final decision regarding the application and issue the registration certificate if approved.

Overall Timeline

In total, the entire process for obtaining Class C medical device registration under MDACS can take approximately 6 to 12 months from the date of application submission to the issuance of the registration certificate. The timeline can be influenced by the factors mentioned above, including the completeness of the application and the complexity of the device.

Summary of Timeline

• Preparation for Application: Several weeks to months (variable).
• Preliminary Review: About 1 to 2 months.
• In-Depth Technical Review: Approximately 3 to 6 months.
• Final Decision: Additional 1 to 2 months.
• Total Duration for Registration: Approximately 6 to 12 months.

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