No, Class I medical device MDACS registration in Hong Kong does not require an annual review. Once a Class I medical device is registered under the Medical Device Administrative Control System (MDACS), the registration remains valid as long as there are no significant changes to the device or the manufacturer's information.

However, the manufacturer or distributor must comply with certain ongoing responsibilities, which include:

1. Post-Market Surveillance: The manufacturer must monitor the device’s performance in the market and report any adverse events or issues to the Hong Kong Department of Health (DH).

2. Changes in the Product: If there are any significant changes to the product (e.g., design, intended use, manufacturing process), the manufacturer must notify the DH and, in some cases, update the registration.

3. Updating Contact Information: If there are any changes to the manufacturer’s contact details or distribution channels, these should be updated with the DH.

4. Compliance with Safety Standards: The device must continue to comply with the safety and quality standards outlined in the initial registration. If regulatory changes occur that affect the device, the manufacturer must ensure ongoing compliance.

So while there isn't an annual review process, manufacturers must stay proactive in ensuring that their device remains compliant and report any necessary updates to the DH.

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