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What documents are needed for Class III medical device MDACS registration in Hong Kong? How to prepare the application files?
Release time：2025-04-29 15:21:49 The author: source:
To register a Class III medical device under MDACS (Medical Device Administrative Control System) in Hong Kong, a structured set of documents is required. Below is a complete breakdown of the required documents and how to prepare the application files.

To register a Class III medical device under MDACS (Medical Device Administrative Control System) in Hong Kong, a structured set of documents is required. Below is a complete breakdown of the required documents and how to prepare the application files.

📄 Required Documents for Class III MDACS Registration

#DocumentDescription
1️⃣MDRR-1 FormOfficial application form for listing the device. Must be completed and signed by the LRP.
2️⃣Device DescriptionOverview of the device, design, components, intended use, contraindications, and classification rationale.
3️⃣Reference Regulatory Approval Certificate(s)Proof of marketing approval in at least one reference market (e.g., CE certificate, FDA 510(k), TGA ARTG certificate, etc.).
4️⃣Free Sale CertificateIssued by the competent authority in a reference market country stating the device is legally marketed there.
5️⃣ISO 13485 CertificateQMS certificate of the manufacturer issued by an accredited body (must show scope includes relevant device manufacturing).
6️⃣Essential Technical Documents (ETD)Including:

  • Instructions for Use (IFU)

  • Labels and artwork

  • Packaging materials

  • Technical specifications

  • Manufacturing process flowchart

  • Risk analysis summary | | 7️⃣ | Clinical Evaluation Report (CER) | Required especially for implantable or high-risk devices. Should comply with MEDDEV 2.7.1 Rev. 4 or equivalent standard. | | 8️⃣ | Post-Market Surveillance (PMS) Plan | Describe procedures for monitoring, complaint handling, incident reporting, and corrective actions. | | 9️⃣ | Photos of Device and Packaging | Clear, color images showing the product, its packaging, labeling, and any accessories. | | 🔟 | Authorization Letter for LRP | Official letter from the manufacturer designating and authorizing the Hong Kong LRP. | | 1️⃣1️⃣ | Business Registration Certificate (of LRP) | Valid business registration certificate issued by Hong Kong's Inland Revenue Department. |

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