Cost and Timeline for Applying for Class II Medical Device MDACS Registration in Hong Kong

The Medical Device Administrative Control System (MDACS) in Hong Kong is a voluntary system designed to regulate medical devices in the market. The cost and processing time for Class II medical device registration under MDACS can vary, but here's an overview of what you can generally expect:

1. Cost of Registration

The cost of applying for Class II medical device registration under MDACS depends on several factors, such as the type of device, the number of devices being registered, and whether the manufacturer is located within Hong Kong or abroad.

a. Registration Fee

• The registration fee for Class II medical devices is generally lower than that for Class III devices, as Class II devices are considered moderate-risk.

• As of the most recent updates, the typical fees for Class II registration can range from HKD 5,000 to HKD 10,000. However, these fees are subject to change and may vary depending on the specific device and any updates to the regulatory framework.

You can confirm the exact fee schedule by visiting the Hong Kong Department of Health or contacting the Medical Device Control Office (MDCO) directly.

b. Additional Costs

In addition to the registration fee, manufacturers may incur other costs, including:

• Legal and consulting fees (if you hire a regulatory consultant or legal expert to assist with the process).

• Local representative fees (if the manufacturer is based outside Hong Kong and needs to appoint a local authorized representative).

• Testing and certification fees for compliance with international standards (e.g., ISO 13485, ISO 14971).

2. Timeline for Registration

The timeline for Class II medical device registration under MDACS can vary depending on several factors, such as the complexity of the device, completeness of the application, and the MDCO's workload at the time of submission.

a. Application Processing Time

• Initial Review: The initial review of the application typically takes about 4 to 6 weeks. This involves verifying that all necessary documentation is provided and that the device complies with Hong Kong regulations.

• Additional Documentation or Clarifications: If the MDCO requires more information or clarification, this can extend the review period. In such cases, you may need an additional 2-4 weeks to provide the requested documentation.

• Final Decision: After a thorough review, the MDCO will either approve or reject the registration. If approved, you will receive the registration certificate and your device will be listed in the MDACS database.

b. Total Timeline

• Overall Duration: From the submission of the application to the approval of registration, the entire process typically takes around 2 to 3 months.

  However, this timeframe can vary depending on the efficiency of the application, the completeness of the documentation, and the specific circumstances.

3. Post-Registration and Ongoing Requirements

Once registered, you must comply with post-market surveillance regulations, such as:

• Reporting any adverse events related to the device.

• Periodic updates on the device’s performance.

• Renewing the registration every 5 years.

Summary: Cost and Timeline

• Registration Fee: Approximately HKD 5,000 to HKD 10,000 for Class II medical devices (subject to change).

• Processing Time: Typically 2 to 3 months for approval, depending on the complexity of the device and the completeness of your application.

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