The processing time for Class I IVD medical device registration under Hong Kong's Medical Device Administrative Control System (MDACS) typically ranges from 2 to 6 months. This timeframe may vary depending on several factors, such as:

1. Completeness of the Application: If all required documents are submitted in the correct format and are complete, the processing time will be faster. Any missing or incorrect information may cause delays.

2. Volume of Applications: The processing time may vary depending on the number of applications currently under review by the Medical Device Division (MDD) of the Department of Health.

3. Device Complexity: Although Class I devices are low-risk, if the device requires additional clarification or review of its safety and performance data, it could take longer.

4. Regulatory Backlog: If there is a high volume of applications in the system, processing times could be extended.

Key Factors Affecting Processing Time:

• Application Quality: Complete and well-prepared applications are processed faster.
• Device Evaluation: If the MDD needs additional time to evaluate the safety and performance data, it may add time to the process.
• Communication Delays: If the MDD requires further clarifications or additional documents, it can extend the timeline.

It is advisable to submit all the required materials as early as possible and ensure that the documentation is thorough to avoid delays. You can also reach out to the MDD to inquire about the status of your application or for any specific processing updates.