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How long is the registration period for Class I IVD medical device under Hong Kong MDACS?
Release time：2024-11-11 17:17:36 The author: source:
After the initial registration, the device must undergo renewal at the end of the 5-year period to continue being legally marketed and sold in Hong Kong. The renewal process typically involves submitting updated documentation and ensuring ongoing compliance with regulatory requirements.

The registration period for a Class I IVD medical device under Hong Kong MDACS is 5 years.

After the initial registration, the device must undergo renewal at the end of the 5-year period to continue being legally marketed and sold in Hong Kong. The renewal process typically involves submitting updated documentation and ensuring ongoing compliance with regulatory requirements.

It's important for manufacturers to keep track of the registration expiry date and submit the renewal application before the expiration to maintain uninterrupted market access.

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