The processing time for Class III medical device MDACS registration in Hong Kong typically takes around 2 to 4 months, depending on several factors such as:

1. Completeness of Application: If all documents are correctly completed and provided, the review process is faster. Incomplete or incorrect submissions can delay the process.

2. Complexity of the Device: High-risk devices (such as implantable devices or those with complex clinical data requirements) may take longer to review due to the need for detailed assessment.

3. Regulatory History: Devices that have already been approved in other reputable markets (e.g., EU, FDA, TGA) may be processed more quickly, as their regulatory review history is well-established.

4. Additional Requests: If the Medical Device Division (MDD) needs additional information or clarification from the applicant, this may extend the timeline.

Key Milestones in the Processing:

• Initial review: The MDD typically conducts an initial review within a few weeks to ensure all necessary documentation is present.

• In-depth review: For Class III devices, this involves checking clinical evaluation reports, safety, performance data, and compliance with international standards.

• Final approval: Once the MDD is satisfied with the application, the device is listed under MDACS, and the manufacturer will receive the official registration.

Tips to Ensure Faster Processing:

• Submit Complete Documentation: Ensure all required forms and documents are accurate and up-to-date.

• Appoint a Local Responsible Person (LRP): Having an LRP in Hong Kong helps with communication and speeding up the process.

• Pre-Approval Consultation: You may contact the Medical Device Division (MDD) to ask for clarification or to ensure that your device is classified correctly and that your documentation is in order.

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