The registration cycle for Class IV medical devices under Hong Kong MDACS (Medical Device Administrative Control System) typically follows a 5-year duration. Here's how the registration cycle works:

1. Initial Registration

• The registration for Class IV medical devices is valid for 5 years from the date of approval by the Hong Kong Department of Health.

• During this period, the device is allowed to be marketed, sold, and distributed within Hong Kong.

2. Post-Market Surveillance and Compliance

• Throughout the 5-year period, the manufacturer must ensure ongoing post-market surveillance to monitor the safety and performance of the device.

• Any adverse events, product recalls, or safety issues must be reported to the Department of Health as part of the post-market obligations.

3. Renewal Process

• Before the end of the 5-year period, the manufacturer must submit an application for renewal to maintain the device's registration status.

• The renewal process involves ensuring the device continues to meet the regulatory requirements and may require updated documentation or proof of compliance with safety standards.

Key Considerations:

• Timely Renewal: It's essential to apply for renewal before the expiration of the registration to avoid a gap in market access.

• Updated Documentation: If there are any significant changes to the device or its manufacturing process, new documentation may be required during the renewal application.

In summary, the registration for a Class IV medical device under MDACS lasts 5 years, and the device must undergo a renewal process before the expiration to continue being marketed and sold in Hong Kong.

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