中文|English
中文|English
What documents are required for Class B medical device MDACS registration in Hong Kong? How to prepare the application files?
Release time：2025-05-26 16:01:20 The author: source:
To apply for Class B medical device registration under MDACS in Hong Kong, you must submit a comprehensive application package to the Medical Device Division (MDD) of the Department of Health. Below is a detailed guide on the required documents and how to prepare them correctly.

To apply for Class B medical device registration under MDACS in Hong Kong, you must submit a comprehensive application package to the Medical Device Division (MDD) of the Department of Health. Below is a detailed guide on the required documents and how to prepare them correctly.

📑 Required Documents for Class B MDACS Registration

Document TypeName / DescriptionNotes
1. Application FormForm MD1 – Medical Device Listing ApplicationMust be filled out and signed by the Local Responsible Person (LRP)
2. LRP AppointmentLetter of Authorization from the manufacturerAppointing the Local Responsible Person (LRP) in Hong Kong
3. Regulatory ApprovalAt least one approval from a Reference Market: CE (MDD/MDR), FDA 510(k), TGA ARTG, Health Canada MDL/MDALL, Japan PMDASubmit copy of certificate and summary of approval. If not available, full technical documentation is required.
4. Quality System CertificateISO 13485 certificate for the manufacturerShould be issued by an accredited body and valid at the time of submission
5. Declaration of Conformity (DoC)From the manufacturerShould reference relevant regulations (e.g., MDR 2017/745) and be signed/dated
6. Device DescriptionProduct brochure/spec sheetInclude intended use, design, components, models/variants, technical specifications
7. Device Classification JustificationRisk classification rationaleJustify why the device is considered Class B under MDACS (based on GHTF principles)
8. Labelling & PackagingOuter packaging, product labels, UDI (if applicable)In English and/or Chinese – must include product name, model, manufacturer, LRP info
9. Instructions for Use (IFU)User manual or IFUIn English or Chinese, showing indications, warnings, installation/use instructions
10. Manufacturer’s InformationName, address, and business license (if available)Include manufacturing site details
11. Safety & Performance EvidenceSummary of relevant standards/tests (e.g., ISO 10993, IEC 60601, etc.)Especially useful if no prior approval is available
12. Other Supporting DocsCatalogs, photos, risk management summary, clinical data (if available)Optional but strengthens submission

cdc-XLhDvfz0sUM-unsplash(2).jpg

Contact Us：

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


Last one: How to apply for Class B medical device MDACS registration in Hong Kong? Where to handle the application?
The next one: What is the process, required documents, and important considerations for Class B medical device MDACS registration in Hong Kong?
return