To apply for Class II medical device registration under the Medical Device Administrative Control System (MDACS) in Hong Kong, several key conditions must be met. These conditions ensure the safety, performance, and quality of the device before it can be listed and marketed in Hong Kong.

Here are the main conditions that must be satisfied:

1. Classification of the Device

• Class II: The device must meet the criteria for Class II medical devices as per the MDACS classification rules.

  • Class II devices are typically devices that pose moderate risks and include products such as diagnostic equipment, surgical instruments, and medical devices for monitoring patient health.

  • If you're unsure of the classification, MDCO may provide classification guidance.

2. Compliance with Safety and Performance Standards

• The device must comply with international safety and performance standards such as:

  • ISO 13485 for quality management systems.

  • ISO 14971 for risk management.

  • IEC 60601 for electrical safety (for electrical medical devices).

• Proof of conformity to these standards should be included in your application. Common evidence includes:

  • CE Marking (for devices compliant with EU regulations).

  • FDA approval (if the device is sold in the US).

  • Other recognized regulatory approvals (e.g., Australian TGA, Japanese PMDA, etc.).

3. Manufacturer and Device Documentation

• The manufacturer must provide accurate and complete details, including:

  • Manufacturing country.

  • Business registration certificate (if available).

  • Certificate of Free Sale from the country of origin (proving the device is legally marketed in that country).

• The device description must be comprehensive, including:

  • Intended use and indications.

  • Risk classification.

  • Working principle and features.

  • Model variations (if any).

4. Local Responsible Person (LRP)

• If the manufacturer is based outside Hong Kong, a Local Responsible Person (LRP) must be appointed.

  • The LRP must have a business registration in Hong Kong and be authorized to act on behalf of the manufacturer.

  • The LRP will handle communication with MDCO and other regulatory bodies in Hong Kong.

5. Clinical Evidence (if applicable)

• Some Class II devices may require clinical evidence to demonstrate the device's performance and safety.

  • Clinical data can include clinical trials, published literature, or data from other regulatory approvals (e.g., CE, FDA).

  • If your device has been approved or cleared by another regulatory body (e.g., FDA or CE-marked), clinical evidence may not be necessary if the device is substantially equivalent.

6. Risk Management Compliance

• The device must follow the ISO 14971 standard for risk management:

  • You need to show that the device has been risk-assessed and any identified risks have been mitigated.

  • A risk analysis report must be included, demonstrating how the device complies with safety requirements.

7. Device Labeling and Instructions for Use

• The device must have proper labeling, which should include:

  • Product name, model, and manufacturer’s details.

  • Intended use, indications for use, and contraindications.

  • Instructions for use, warnings, and maintenance guidelines.

• Samples of the device label and the user manual must be provided with the application.

  • The label must be in English or Chinese.

8. Manufacturing Practices and Quality Control

• The manufacturer must provide proof of good manufacturing practices (GMP), usually in the form of an ISO 13485 certificate or equivalent, to ensure the device is consistently produced under controlled conditions.

• Documentation showing the manufacturer's adherence to these practices should be submitted.

9. Authorized Representative Appointment (if applicable)

• If the manufacturer is located outside of Hong Kong, they must formally appoint an Authorized Representative in Hong Kong to handle regulatory matters, such as submissions to the MDCO.

10. Device Intended for Market in Hong Kong

• The device must be intended to be marketed and sold in Hong Kong. The registration is only valid within the Hong Kong jurisdiction.

11. No Outstanding Compliance Issues

• Ensure that there are no outstanding issues regarding the device’s regulatory history, such as:

  • Ongoing enforcement actions, penalties, or bans in other jurisdictions.

  • Non-compliance with regulatory requirements (e.g., CE, FDA).

By meeting all of these conditions, the Class II medical device will be eligible for MDACS registration. After the registration is complete, you can market the device in Hong Kong with the MDACS listing certificate, though the registration is currently voluntary.

Contact Us：

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