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What materials are needed for Class IV medical device registration under Hong Kong MDACS? How to prepare the application documents?
Release time：2025-04-30 15:28:46 The author: source:
For Class IV medical device registration under Hong Kong MDACS, the preparation of application materials is critical for a smooth and successful listing. Below is a complete guide on the materials needed and how to prepare each document.

For Class IV medical device registration under Hong Kong MDACS, the preparation of application materials is critical for a smooth and successful listing. Below is a complete guide on the materials needed and how to prepare each document.

📋 Materials Required for Class IV Medical Device Registration (MDACS)

The application package generally includes the following categories:

1. Administrative Documents

DocumentPreparation Guidelines
Form MD4Download from MDD website. Must be completed and signed by the Local Responsible Person (LRP). Include product details, risk classification, reference country approval, and device description.
Authorization LetterIssued by the manufacturer, authorizing the LRP to act on their behalf in Hong Kong. Should be on company letterhead and include signatures of both parties.
LRP Business Registration CertificateA copy of the Hong Kong BR Certificate of the Local Responsible Person. Must be valid and up-to-date.
Certificate from Reference MarketE.g., CE Certificate, FDA 510(k)/PMA, TGA ARTG certificate, etc. Must show the device is approved in a reference country.
Declaration of Conformity (DoC)Issued by the manufacturer, declaring compliance with applicable standards (e.g., MDR, ISO 13485). Must list applicable directives/standards.
Manufacturer and LRP Contact DetailsIncluding name, address, phone, and responsible personnel.

2. Technical Documentation

DocumentPreparation Tips
Device DescriptionInclude the model name, catalog number, configuration, components/accessories, and detailed intended use. Add color images if possible.
Design and Manufacturing InformationInclude production process, quality control checks, and information on manufacturing sites.
Risk Analysis ReportBased on ISO 14971. Include risk identification, evaluation, and control measures.
Clinical Evaluation Report (CER)Must demonstrate safety and performance. Can follow MEDDEV 2.7/1 Rev. 4 or MDR Annex XIV. Should include literature review, PMS data, and if applicable, clinical trials.
Quality System CertificateValid ISO 13485 certificate of the manufacturer (not expired, and ideally issued by a recognized body).
Labeling and IFUProvide final version of product label, packaging, and Instructions for Use. Must be in English or Chinese and comply with local labeling standards.
Product PhotosClear color photos showing device configuration, components, labeling, and packaging.
Post-Market Surveillance (PMS) PlanDescribe how the manufacturer collects and analyzes post-market data and handles adverse events.

🧾 Document Preparation Guidelines

🔹 Formatting

  • All documents should be in English or Chinese.

  • Use standard A4 size, organized by a table of contents.

  • Submit both hard copies and digital files (CD-ROM or USB).

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