To handle Class C medical device registration under Hong Kong's Medical Device Administrative Control System (MDACS), you need to meet several specific requirements to demonstrate that your device is safe, effective, and of good quality. Class C devices are considered medium-high risk, so the documentation and compliance needed are more rigorous than for lower-risk devices.

Key Requirements for Class C Medical Device Registration

1. Device Classification

• Confirm that your device falls under Class C, which refers to medium-high risk devices. This classification is determined by the intended use and the potential risk to the patient.

2. Compliance with Essential Principles

• The device must comply with the Essential Principles of Safety and Performance of Medical Devices. These are internationally recognized standards that ensure the device is designed and manufactured to be safe and effective.
• You must provide evidence of this compliance through documents like conformity assessments, clinical data, and risk management reports.

3. Required Documentation

• You need to prepare and submit the following documents as part of your application:

  a. Application Form (MD-C2):
  Complete the MD-C2 form, which is the official application for registration.

  b. Device Description and Technical Specifications:
  A detailed description of the medical device, including its intended use, design, materials, and specifications.

  c. Conformity Assessment Evidence:
  Proof that the device conforms to international standards such as:

  • CE marking under the European Medical Devices Directive (MDD/MDR)
  • US FDA approval
  • ISO 13485 certification (or an equivalent quality management system certification)
  • Test reports and certification from a recognized third-party body (e.g., a notified body).

  d. Essential Principles Checklist:
  A checklist demonstrating that your device complies with all relevant safety and performance requirements.

  e. Risk Management Report:
  A risk management report based on ISO 14971 or equivalent, outlining the risks associated with the device and how they are mitigated during design and manufacturing.

  f. Clinical Evidence:
  Data from clinical trials or evaluations demonstrating the safety, efficacy, and performance of the device in its intended use.

  g. Post-Market Surveillance Plan:
  A plan for monitoring the safety and performance of the device after it is placed on the market. This should include procedures for identifying and reporting adverse events.

  h. Manufacturer’s Information:
  Information about the manufacturer, including company details, the manufacturing facility, and proof of compliance with regulatory standards (e.g., ISO 13485).

  i. Labeling and Instructions for Use:
  Provide product labeling and user manuals. These should include:

  • The intended purpose of the device
  • Instructions for use
  • Warnings and precautions
  • Any contraindications or side effects

  j. Declaration of Conformity:
  A signed declaration stating that the device meets all applicable regulatory requirements and conforms to the Essential Principles of Safety and Performance.

  k. Authorized Local Representative (if applicable):
  If you are an overseas manufacturer, you need to appoint a local authorized representative in Hong Kong. This representative will serve as the point of contact for regulatory matters.

4. Application Fee

• A non-refundable application fee must be paid when submitting the application. The fee amount depends on the device class and is set by the Medical Device Control Office (MDCO). Refer to the MDCO website for the most up-to-date fee structure.

5. Post-Market Surveillance and Adverse Event Reporting

• You must have a system in place to monitor the safety and performance of the device after it has been marketed. This includes tracking and reporting adverse events or product recalls to the MDCO.
• Submit periodic reports and updates to the MDCO if there are changes in the device design, manufacturing process, or safety profile.

6. Quality Management System (QMS)

• The manufacturer must have an effective Quality Management System (e.g., ISO 13485 certification). This ensures that the design, development, manufacturing, and quality control processes are in compliance with international standards.

7. Renewal of Registration

• Class C medical device registrations are typically valid for five years. Before expiration, you need to apply for renewal by submitting updated documentation and paying the renewal fee.

Summary of Key Requirements:

1. Classification: Ensure the device is correctly classified as Class C.
2. Compliance with Essential Principles: Meet safety and performance standards.
3. Documentation: Provide application forms, technical specifications, risk management, clinical evidence, conformity assessments, labeling, and more.
4. Application Fee: Pay the required non-refundable fee.
5. Post-Market Surveillance: Set up a plan for monitoring safety and report adverse events.
6. Quality Management System (QMS): Ensure the manufacturer follows recognized quality standards like ISO 13485.
7. Renewal: Keep track of the registration period and renew before expiration.

By meeting these requirements and submitting a complete application, you can successfully register a Class C medical device under Hong Kong MDACS.