The processing time for Class D 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 application, and the current workload of the Medical Device Division (MDD).

Typical Processing Time

• Estimated Timeframe: The processing time is generally 6 to 12 months from the date of submission of a complete application. However, this timeframe can be longer if:
  • Additional information or clarification is required from the applicant.
  • The MDD has a high volume of applications to review.
  • The device presents unique challenges or requires extensive evaluation.

Factors Influencing Processing Time

1. Completeness of Application:

   • A well-prepared and comprehensive application is more likely to be processed quickly. Missing or unclear information can lead to delays as the MDD may need to request further documentation or clarification.

2. Device Complexity:

   • Class D devices are high-risk and often require more thorough evaluations compared to lower-class devices. The complexity of the device and its intended use may influence the length of the review process.

3. Regulatory Queries:

   • If the MDD has questions or concerns regarding the safety, efficacy, or compliance of the device, this can extend the processing time. Prompt responses to any queries can help mitigate delays.

4. Workload of the MDD:

   • The current workload of the Medical Device Division can also affect processing times. Periods of increased submissions may lead to longer wait times for review.

Tips to Expedite Processing

• Ensure Completeness: Double-check that all required documents are included and properly completed before submission.
• Clear and Concise Documentation: Provide clear, concise, and well-organized documentation to facilitate the review process.
• Timely Responses: Be prompt in responding to any requests for additional information from the MDD to avoid unnecessary delays.

By considering these factors and tips, you can help ensure a smoother and potentially quicker processing time for your Class D medical device registration under the Hong Kong MDACS.