中文|English
中文|English
What are the technical documentation requirements for Class B medical device MDACS registration in Hong Kong?
Release time：2025-05-26 16:06:38 The author: source:
For Class B medical device registration under the Medical Device Administrative Control System (MDACS) in Hong Kong, the technical documentation plays a critical role in demonstrating the safety, quality, and performance of the product.

For Class B medical device registration under the Medical Device Administrative Control System (MDACS) in Hong Kong, the technical documentation plays a critical role in demonstrating the safety, quality, and performance of the product.

Below is a detailed guide on the technical documentation requirements for MDACS Class B devices:

📁 Technical Documentation Requirements

Required for Submission with Form MD1 (Device Listing Form)

Document TypeDescriptionNotes
✅ 1. Device Description & ClassificationDetailed product description, intended use, and classification rationaleAlign with MDACS classification rules (GHTF-based)
✅ 2. Labeling & PackagingActual labels, outer packaging, and Instructions for Use (IFU)Must be in English and/or Chinese
✅ 3. Regulatory ApprovalCertificates from reference markets (at least one):
- CE Mark (MDD/MDR)
- US FDA 510(k)/PMA
- TGA ARTG
- Health Canada MDL/MDALL
- Japan PMDA		Mandatory unless full technical file is provided
✅ 4. Declaration of ConformityManufacturer’s declaration confirming conformity with applicable standardsReferencing ISO, IEC, or relevant GHTF/IMDRF standards
✅ 5. Quality Management System CertificateValid ISO 13485:2016 certificate from an accredited bodyScope must cover the device type
✅ 6. Risk Management ReportRisk analysis per ISO 14971Especially if no CE/FDA evidence is submitted
✅ 7. Essential Principles ChecklistMapping of the device to the applicable Essential Principles of Safety and PerformanceRequired if no prior approval exists
✅ 8. Clinical Evidence (if applicable)Clinical evaluation report or literature summaryNot always required for Class B, unless novel technology
✅ 9. Device PhotosHigh-quality color photos of the device and packagingMust clearly show labels and markings
✅ 10. Manufacturer’s InformationBusiness registration or profile (if available)Helps establish credibility
✅ 11. Local Responsible Person Appointment LetterAuthorization from the manufacturer to the LRPMust be signed and dated

🔁 If no reference market approval is available:

You must submit a complete technical file, similar to EU MDR Annex II/III, including:

  • Design drawings & specifications

  • Performance testing (bench, biocompatibility, EMC, electrical safety)

  • Clinical evaluation

  • Manufacturing process details

  • Vigilance & post-market surveillance plan

📌 Format and Language

RequirementNotes
📄 FormatHard copy (organized binder, tabbed sections recommended)
🈯 LanguageEnglish or Chinese only (translated documents must be certified)
📬 SubmissionSend to the Medical Device Division, Department of Health, Hong Kong

louis-reed-JeInkKlI2Po-unsplash(1).jpg

Contact Us：

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


Last one: What are the standards for Class B medical device MDACS registration in Hong Kong?
The next one: What is the processing time for Class B medical device MDACS registration in Hong Kong?
return