Obtaining Class C medical device MDACS registration in Hong Kong serves multiple important purposes, especially for manufacturers and distributors who intend to access the public and private healthcare sectors in the region. Although MDACS (Medical Device Administrative Control System) is currently voluntary, it plays a crucial regulatory, commercial, and compliance role.

🎯 Primary Purpose of Class C MDACS Registration

✅ 1. Enable Legal Market Access in Hong Kong

MDACS registration allows Class C medical devices (medium- to high-risk) to be legally listed and recognized for importation, sale, and use in Hong Kong.

• While not yet a statutory requirement, registration is strongly encouraged by the Hong Kong Department of Health.

• It’s an essential part of good regulatory practice and is widely adopted by public hospitals and clinics.

✅ 2. Participate in Public Sector Procurement

Hong Kong’s Hospital Authority (HA) and public healthcare institutions require MDACS listing for procurement.

• If your Class C device (e.g., diagnostic monitor, infusion system, surgical equipment) is not listed, it is not eligible for public tenders.

• Many private hospitals and clinics also prefer or require MDACS listing as part of their due diligence.

✅ 3. Demonstrate Product Safety, Quality, and Performance

By registering under MDACS, the device is verified to meet essential principles of safety and performance as per international standards, including:

• GHTF/IMDRF principles (aligned with MDACS)

• ISO 13485 (quality management system)

• ISO 14971 (risk management)

• ISO 10993 (biocompatibility)

• IEC 60601 (electrical safety), etc.

🔍 The review by the Medical Device Division (MDD) ensures the product is backed by:

• Reference market approvals (e.g., CE, FDA)

• Clinical evidence

• Compliance with labeling, software safety, and manufacturing quality

✅ 4. Improve Market Competitiveness and Trust

• Devices listed under MDACS carry a Hong Kong Medical Device number (HKMD No.) and are publicly listed in the MDACS database.

• This increases buyer and user confidence in the product’s legitimacy and compliance.

• It gives your product an edge over unlisted competitors and builds your brand credibility in Hong Kong and other Asia-Pacific markets.

✅ 5. Prepare for Future Legal Requirements

The Hong Kong government plans to transition MDACS into a mandatory statutory regulatory system in the future.

• By obtaining registration now, companies are proactively aligning with upcoming legal changes.

• Future conversion from voluntary to mandatory status may prioritize already-listed products.

✅ 6. Meet International Distributor Requirements

• Distributors and agents often require proof of regulatory acceptance in the region.

• Listing the device under MDACS shows the product is locally recognized and compliant with the Hong Kong Department of Health’s expectations.

🔍 Summary Table: Key Purposes of Class C MDACS Registration

📘 Example Scenarios

✅ Conclusion

The purpose of obtaining Class C MDACS registration is not merely procedural—it is strategic, regulatory, and commercial. It ensures your device is recognized, compliant, and accessible in one of Asia’s most transparent and safety-conscious medical device markets.

Contact Us：

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