The cost and time required to apply for Class C medical device registration under Hong Kong’s Medical Device Administrative Control System (MDACS) can vary depending on several factors such as the completeness of the application, the complexity of the device, and the applicant's readiness. Here's an overview of the costs and timeline typically associated with the registration process:

1. Cost of Registration

Application Fee

• There is a non-refundable application fee for registering a Class C medical device under MDACS.
• The exact fee for Class C devices is specified by the Medical Device Control Office (MDCO), and you can refer to the official MDCO website for the most current fee schedule.
• For reference, as of the most recent guidelines:
  • The fee for Class C devices is HKD 5,060 per application.

Additional Costs

• Third-party certification costs (e.g., ISO 13485 certification, CE marking, FDA approval) may be required before submitting the MDACS application.
• Clinical trial costs if additional testing is needed to support the application.
• Consultancy fees if you hire professionals to help with documentation, quality management systems (QMS), or risk management reports.

2. Time Required for Registration

Preparation Time

• The preparation phase can take several months depending on how ready the applicant is. You will need to gather technical documentation, conformity assessments, risk management reports, clinical evidence, and labeling information.
• Typical preparation time: 2 to 6 months, depending on the device's complexity and the availability of documentation.

Review and Approval Time

Once the application is submitted, the MDCO will conduct the following reviews:

• Administrative Review: This ensures that the application form is complete and that all required documents are provided.

• Technical Review: MDCO will assess the safety, performance, and quality of the device. During this time, they may request additional information or clarifications from the applicant.

• Typical review time for Class C devices: 6 to 12 months from the submission of a complete application. Delays may occur if MDCO requires further documentation or evidence.

• The total time for approval can vary based on the complexity of the device and the workload of the regulatory authorities.

3. Total Timeline

• Preparation and Submission: 2 to 6 months (depending on readiness)
• Review and Approval by MDCO: 6 to 12 months
• Total Time Estimate: 8 to 18 months from preparation to final approval.

Summary:

• Cost: Approximately HKD 5,060 for Class C registration (plus potential additional costs for third-party certifications and consultancy).
• Time: Around 8 to 18 months from preparation to approval.

It’s important to note that the timeline and costs can fluctuate based on the completeness of the submission, the complexity of the device, and any additional regulatory requirements that may arise during the review process.

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