To apply for B-class medical device registration under the Medical Device Administrative Control System (MDACS) in Hong Kong, several conditions must be met. These conditions ensure that the medical device meets safety, quality, and regulatory standards required by the Medical Device Control Office (MDCO). Here’s an overview of the key conditions:

1. Classification as a Class B Device

• The medical device must be classified as Class B according to the Medical Device Classification Rules. Class B devices are medium-risk devices, such as certain types of diagnostic equipment, surgical instruments, or dental devices. The classification depends on factors such as the device's intended use, duration of use, and potential impact on the patient.

2. Manufacturer's Quality Management System (QMS)

• The manufacturer must have an established Quality Management System (QMS), usually in accordance with ISO 13485 or an equivalent standard.
  • The QMS ensures that the manufacturer follows good manufacturing practices (GMP) in the design, production, and quality control of the device.
  • A valid ISO 13485 certification (or equivalent) must be provided as evidence of compliance.

3. Evidence of Device Safety and Performance

• The applicant must provide adequate evidence of the device’s safety and performance. This includes:
  • Clinical Data: Clinical studies or evaluations that show the device is safe and effective for its intended use.
  • Preclinical and Performance Testing: Non-clinical data (e.g., bench testing or laboratory results) that support the device's safety and functionality.
  • Biocompatibility Testing: For devices in contact with the human body, proof of biocompatibility is required.

4. Risk Management Compliance

• The manufacturer must demonstrate that they have conducted a thorough risk assessment of the device, in line with ISO 14971 (if applicable), which covers the identification, evaluation, and management of risks throughout the device’s lifecycle.
  • A Risk Management Report must be submitted, outlining potential risks and the steps taken to mitigate them.

5. Conformity to Essential Principles

• The device must meet the Essential Principles of Safety and Performance for medical devices, which are outlined by the MDCO and based on international standards.
  • These principles cover general safety, performance, labeling, risk management, and the device’s design and manufacturing.
  • The manufacturer must submit a Declaration of Conformity confirming that the device complies with these principles.

6. Device Labeling and Instructions for Use

• The medical device must have proper labeling and Instructions for Use (IFU) in accordance with MDCO requirements. The labeling should include:
  • Device name and model.
  • Manufacturer’s name, address, and contact information.
  • Batch number, serial number, or lot number.
  • Instructions for use, precautions, and warnings.
  • Clear identification of the device’s intended use.

7. Post-Market Surveillance Plan

• The manufacturer must develop a Post-Market Surveillance Plan to monitor the device’s safety and performance after it is on the market. This includes systems for handling complaints, managing adverse events, and implementing corrective actions if necessary.
  • The plan should include procedures for reporting adverse events to the MDCO.

8. Device Registration or Approval in Other Jurisdictions (Optional)

• While not a strict requirement, if the device has been approved or registered in other jurisdictions (e.g., FDA in the U.S., CE marking in Europe), it can strengthen the application. Evidence of this approval, such as registration certificates or declarations, can be submitted as supporting material.

9. Local Authorized Representative (if Applicable)

• If the manufacturer is not based in Hong Kong, they must appoint a Local Authorized Representative (LAR) who is based in Hong Kong to handle the registration process. The LAR will act on behalf of the manufacturer for communication with the MDCO and post-market responsibilities.

10. Payment of Application Fees

• The required application fees must be paid at the time of submission. Fees vary depending on the type of device and the complexity of the review, and the fee schedule can be found on the MDCO website.

Summary of Conditions to Apply for B-Class Medical Device MDACS Registration

1. Device Classification: The device must be a Class B medical device.
2. Manufacturer’s Quality System: The manufacturer must have an ISO 13485-compliant Quality Management System.
3. Evidence of Safety and Performance: Adequate clinical and preclinical evidence must be provided.
4. Risk Management: Compliance with ISO 14971 risk management requirements is necessary.
5. Conformity to Essential Principles: The device must meet the Essential Principles of Safety and Performance.
6. Labeling and Instructions for Use: The device must have compliant labeling and instructions.
7. Post-Market Surveillance Plan: A system must be in place for monitoring device performance after market entry.
8. Registration in Other Jurisdictions (optional): Any prior approval from other regulators may be submitted.
9. Local Authorized Representative: A local representative must be appointed if the manufacturer is based outside Hong Kong.
10. Fee Payment: Application fees must be paid.