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How much does it cost and how long does it take to obtain Class C medical device MDACS registration in Hong Kong?
Release time：2025-06-25 15:36:48 The author: source:
Obtaining Class C medical device registration under Hong Kong’s Medical Device Administrative Control System (MDACS) involves no official government fees, but indirect costs and a moderate registration timeline are involved.

Obtaining Class C medical device registration under Hong Kong’s Medical Device Administrative Control System (MDACS) involves no official government fees, but indirect costs and a moderate registration timeline are involved.

💰 Cost of Class C Medical Device MDACS Registration in Hong Kong

🔹 1. Official Government Fees

  • ✅ HK Department of Health charges: FREE

    • There is currently no application fee for MDACS device listing (Form MD102)

    • No fee for manufacturer (Form MD101) or LRP registration (Form MD100)

🟩 Total official MDACS registration fees: $0

🔹 2. Indirect/Third-Party Costs

While the application itself is free, the associated preparation costs typically include:

ItemEstimated Cost Range (USD)
✅ Local Responsible Person (LRP) services$1,000 – $3,000/year
✅ Document translation (if needed)$200 – $800
✅ Regulatory consulting services (optional)$1,500 – $5,000
✅ Technical document preparation support$500 – $2,000
✅ Notarization/legalization (if required)$100 – $300
✅ Courier/shipping (physical submission required)$50 – $200

💡 Total expected cost (if using a local agent): approximately $2,000–$8,000 USD, depending on:

  • Complexity of the product

  • Number of documents requiring translation or legalization

  • Whether you use internal regulatory resources or outsource to a consultant

⏳ Time Required for Class C MDACS Registration

🔹 1. Preparation Phase

ActivityTime Estimate
Document collection and formatting2–6 weeks
Translation & notarization1–2 weeks
Manufacturer & LRP registration (MD100, MD101)1–2 weeks
Submission preparation (Form MD102)1 week

🧾 Preparation time: ~ 4 to 8 weeks

🔹 2. Review and Listing by Medical Device Division (MDD)

After submission, the MDD will review the technical dossier and decide on listing eligibility.

Review ActivityDuration
MDD administrative review1–2 weeks
Technical evaluation of documents8–16 weeks
Clarification & response (if required)2–4 weeks (if applicable)

🕒 Average review time: 4 to 6 months

⚠️ Timelines may vary depending on:

  • Completeness and quality of submission

  • Whether the device is already approved in reference markets

  • Response speed for clarification requests

📌 Total Time Estimate Summary

StageDuration
Preparation1–2 months
MDD Review4–6 months
Total5–8 months

✅ Summary Table: Class C MDACS Registration in Hong Kong

ItemDetail
Official Fee$0 (free of charge)
Indirect Costs$2,000 – $8,000 USD
Preparation Time1–2 months
Review Time4–6 months
Total Time5–8 months
RenewalNot required (but post-market reporting is mandatory)

📎 Need help estimating costs for your specific product or finding a qualified LRP in Hong Kong?

I can assist with:

  • A sample cost quotation

  • List of licensed LRPs or local regulatory consultants

  • Editable templates for Forms MD100, MD101, MD102

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Contact Us：

Whatsapp or Wechat：+86 15816864648；email address：hito.lin@grzan.cn


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