中文|English
中文|English
How to apply for Class A medical device registration under Hong Kong MDACS? Where to handle it?
Release time：2025-05-14 14:08:17 The author: source:
To apply for Class A medical device registration under Hong Kong's Medical Device Administrative Control System (MDACS), follow this structured guide

To apply for Class A medical device registration under Hong Kong's Medical Device Administrative Control System (MDACS), follow this structured guide:

✅ HOW TO APPLY FOR CLASS A MEDICAL DEVICE REGISTRATION (MDACS)

🧾 Step-by-Step Application Process

StepDescription
1️⃣Confirm Classification – Ensure the device qualifies as Class A (low-risk, non-invasive, non-sterile). Use Guidance Note GN-01 for reference.
2️⃣Appoint a Local Responsible Person (LRP) – Required if the manufacturer is not based in Hong Kong. The LRP must first be listed with the Medical Device Division (MDD).
3️⃣Prepare Application Documents – Complete and compile the required documents (see list below).
4️⃣Submit Application – Send the application by post or in person to the MDD. There is no online portal.
5️⃣Await Review – MDD reviews and may request clarification. If accepted, the device will be listed on the MDACS website.

📍 WHERE TO APPLY (Handling Office)

Submission Address:

Medical Device Division (MDD)
Department of Health
Room 3101, 31/F, Hopewell Centre
183 Queen’s Road East
Wan Chai, Hong Kong

Contact Info:

📑 REQUIRED DOCUMENTS

  1. MD-TRF Form – Class A Device Listing Form

  2. Device Description – Technical, functional, and visual details

  3. Classification Justification – Written rationale per MDACS GN-01

  4. Product Labeling & IFU – Label, packaging, and user instructions

  5. Manufacturer Details – Contact info and regulatory history

  6. (Optional) CE Declaration, FDA clearance, ISO 13485 certificate

💰 Fee & ⏳ Processing Time

  • Application Fee: HK$0 (free)

  • Estimated Time: 1–3 months, depending on document quality and MDD workload

cdc-FcIrL0o71Dk-unsplash.jpg

Contact Us：

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


Last one: What conditions must be met to apply for Class A medical device registration under Hong Kong MDACS?
The next one: What materials are needed for Class A medical device registration under Hong Kong MDACS? How to prepare the application documents?
return