The duration for Class C medical device registration under the Hong Kong Medical Device Administrative Control System (MDACS) typically involves several stages and can vary based on several factors, including the complexity of the device and the completeness of the application. Here’s a breakdown of the overall timeline:

1. Initial Application Submission

• Preparation Time: Before submission, manufacturers must prepare the necessary technical documentation, risk assessments, clinical evidence, and other supporting documents. This preparation can take several weeks or months, depending on the readiness of the information.

2. Preliminary Review by MDCO

• Duration: After submission, the Medical Device Control Office (MDCO) conducts a preliminary review to check the completeness of the application. This phase usually takes about 1 to 2 months.

3. In-Depth Technical Review

• Duration: Following the preliminary review, MDCO performs a comprehensive evaluation of the technical documentation, which can take approximately 3 to 6 months. The timeline may vary based on:
  • The complexity of the device.
  • The thoroughness of the submitted data.
  • The need for additional information or clarification from the manufacturer.

4. Post-Market Surveillance Plan Review

• Duration: The review of the post-market surveillance plan 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: After completing the technical review, MDCO makes a final decision regarding the application, which can take an additional 1 to 2 months.

Overall Timeline

In total, the entire registration process for Class C medical devices under MDACS can take approximately 6 to 12 months from the date of application submission to the issuance of the registration certificate, depending on the factors mentioned above.

Post-Registration Duration

Once registered, the Class C medical device registration is valid for 5 years. Manufacturers must apply for renewal before the expiration of the registration and continue to adhere to post-market surveillance and reporting obligations during this period.

Summary of Duration

• 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.
• Validity of Registration: 5 years before requiring renewal.

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