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How long does it take to obtain Class B medical device MDACS registration in Hong Kong?
Release time：2025-05-26 16:15:29 The author: source:
Obtaining Class B medical device MDACS registration in Hong Kong generally takes about 8 to 14 weeks (approximately 2 to 3.5 months) from the date of application submission to receiving approval.

Obtaining Class B medical device MDACS registration in Hong Kong generally takes about 8 to 14 weeks (approximately 2 to 3.5 months) from the date of application submission to receiving approval.

Timeline breakdown:

  • Initial document screening: 2–4 weeks

  • Technical review: 4–8 weeks

  • Final approval and issuance of registration number: 1–2 weeks

Note: Delays may occur if additional information or clarification is requested by the Medical Device Division.

If your documentation is complete and responses are timely, the process may be faster. Need help preparing your application to speed things up?

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