To apply for B-class medical device registration under the Medical Device Administrative Control System (MDACS) in Hong Kong, you need to follow a step-by-step process. Here’s how to apply and where to handle the registration:

1. Steps to Apply for B-Class Medical Device MDACS Registration

A. Confirm Device Classification

• Ensure that your medical device is classified as Class B according to the Medical Device Classification Rules. This step is crucial to determine whether your device falls under Class B, which typically includes medium-risk devices.

B. Prepare Required Documents

• Collect and prepare the necessary materials for registration (see below for details on required documents):
  • Application Form: Complete the official MDACS application form.
  • Device Description: Provide a detailed description of the device and its intended use.
  • Safety and Performance Data: Include clinical, preclinical, and performance testing data to support the device’s safety and effectiveness.
  • Labeling and Instructions for Use (IFU): Prepare the labels and user instructions for the device.
  • Quality Management System (QMS) Documentation: Submit documents proving compliance with ISO 13485 or similar standards.
  • Risk Management Report: Provide a report detailing the risk assessment of the device.
  • Post-Market Surveillance Plan: Outline how you will monitor the device after it’s on the market.
  • Declaration of Conformity: Include a formal declaration from the manufacturer that the device meets relevant standards.

C. Submit the Application

• Submission Options:
  • Online Submission: The easiest way is to submit your application electronically via the MDACS e-portal on the Medical Device Control Office (MDCO) website.
  • Physical Submission: Alternatively, you can mail or deliver the application and documents in hard copy to the MDCO office.

2. Where to Handle the Registration

Medical Device Control Office (MDCO)

The MDCO, under the Hong Kong Department of Health, is responsible for overseeing the registration of medical devices under MDACS.

Online Submission Portal

• MDACS e-portal: You can register your B-class medical device via the MDACS e-portal on the MDCO website.
  • Website: MDCO Website
  • Through this portal, you can upload your application form and supporting documents electronically, track the application status, and communicate with the MDCO.

In-Person or Mail Submission

• If you prefer submitting the documents physically, you can send them to the MDCO at the following address:

  Medical Device Control Office
  Department of Health
  16/F, Wu Chung House,
  213 Queen's Road East,
  Wan Chai, Hong Kong

  Contact Information:

  • Telephone: +852 3107 8478
  • Email: mdco@dh.gov.hk

3. What to Expect After Submission

Application Review

• Once submitted, the MDCO will review the application and may request additional information or clarifications. The typical review time can range from 4 to 8 weeks, depending on the complexity of the device and the completeness of the documentation.

Approval

• If the application meets all requirements, the MDCO will issue a registration certificate. This certificate allows the device to be legally marketed in Hong Kong.

4. Tips for a Successful Application

• Complete Documentation: Make sure all required documents are included and properly filled out to avoid delays.
• Clear Communication: Respond promptly to any requests for additional information from the MDCO.
• Consult Experts: If you’re unfamiliar with the registration process, consult with regulatory affairs experts or legal advisors to ensure compliance.
• Stay Updated: Check the MDCO website regularly for updates on guidelines or changes in regulatory requirements.

Summary

To apply for B-class medical device registration under MDACS in Hong Kong, you need to prepare the necessary documentation, including an application form, safety data, QMS documentation, and risk management reports. You can submit the application online via the MDACS e-portal or send it to the Medical Device Control Office in Hong Kong. After submission, the MDCO will review the application, and if approved, you will receive a registration certificate allowing your device to be sold in Hong Kong.