The purpose of obtaining Class D medical device MDACS registration in Hong Kong is to ensure that high-risk medical devices meet internationally recognized standards of safety, performance, and quality before they are marketed, imported, or used in Hong Kong. Although the Medical Device Administrative Control System (MDACS) is currently voluntary, it plays a critical regulatory role and is widely recognized by healthcare institutions, customs, and public hospitals.

🎯 Primary Purposes of Class D MDACS Registration

1. ✅ Market Access and Acceptance

• Public and private hospitals (including the Hospital Authority) often require MDACS listing for procurement.

• Medical devices not listed under MDACS may face rejection in government tenders and clinical usage.

📌 In practice, MDACS registration functions as a de facto approval system in Hong Kong.

2. ✅ Demonstration of Safety and Performance

• MDACS ensures that Class D medical devices comply with the Essential Principles of Safety and Performance (GN-01 / GN-02).

• High-risk devices must show evidence of:

  • Effective risk control

  • Valid clinical performance

  • Verified manufacturing quality (ISO 13485)

🧠 This increases user trust and reduces liability for healthcare providers.

3. ✅ Recognition of International Standards

• Devices that are CE-marked, FDA-cleared, TGA-approved, or approved by other reference authorities can leverage existing approvals under MDACS.

• The MDACS framework aligns with GHTF/IMDRF guidelines, making it internationally harmonized.

🌍 This streamlines registration for multinational manufacturers.

4. ✅ Support for Customs Clearance and Importation

• While Hong Kong has no mandatory pre-market approval law, customs officials and port authorities often require MDACS documentation for Class D devices, especially if the product is:

  • Intended for public hospitals

  • Imported in large quantities

  • Under regulatory scrutiny

📦 MDACS listing simplifies logistics, inspections, and warehousing.

5. ✅ Regulatory Readiness and Future Compliance

• The Hong Kong government is planning to move toward a mandatory system. MDACS registration now prepares manufacturers for:

  • Future legal compliance

  • Rapid transition to statutory regulation

• It also supports compliance with related regulatory systems like:

  • Hong Kong Hospital Authority requirements

  • Local ethical committee and clinical trial approvals

6. ✅ Post-Market Surveillance and Patient Safety

• Class D listing under MDACS mandates the manufacturer and LRP to:

  • Report adverse events (AEs)

  • Manage recalls and Field Safety Corrective Actions (FSCA)

  • Maintain a post-market surveillance plan

• This improves public health outcomes and reduces regulatory risks.

🛡 Listing ensures continuous safety monitoring of high-risk devices in the market.

🧾 Examples of Class D Devices That Need MDACS Listing

🧠 Why MDACS is Practically Necessary (Though Not Mandatory)

📌 Conclusion

The purpose of obtaining Class D MDACS registration in Hong Kong is to:

✅ Facilitate access to hospitals and clinics
✅ Demonstrate safety, performance, and international compliance
✅ Enable smooth customs clearance and distribution
✅ Fulfill post-market surveillance obligations
✅ Position the product for future legal regulation

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