Applying for B-class medical device registration under the Medical Device Administrative Control System (MDACS) in Hong Kong involves a structured process to ensure compliance with safety and regulatory standards. Here’s a detailed breakdown of the processes involved in applying for MDACS registration:

Processes for Applying for B-Class Medical Device MDACS Registration

1. Classification of the Device

• Identify Device Type: Determine if your device falls under the B-class category based on its characteristics and intended use.
• Review Classification Guidelines: Use the MDCO guidelines to ensure accurate classification.

2. Prepare Technical Documentation

• Compile Required Documents: Gather all necessary documents that demonstrate the safety, efficacy, and quality of the device. Key documents typically include:
  • Device Description: Details about the device, its intended use, and target population.
  • Design and Manufacturing Information: Information on the manufacturing process, materials, and quality control measures.
  • Risk Management Report: Documentation of the risk management process in accordance with ISO 14971.
  • Clinical Data: If applicable, provide data supporting the safety and performance of the device.
  • Quality Management System (QMS): Evidence of compliance with ISO 13485 or similar standards.

3. Conduct Risk Assessment

• Risk Analysis: Identify potential risks associated with the device’s use and assess their impact.
• Mitigation Strategies: Document strategies to mitigate identified risks and include this information in your technical documentation.

4. Prepare Labeling and Instructions for Use (IFU)

• Labeling Requirements: Ensure the device labeling meets the standards set by ISO 15223 and includes all necessary information.
• Instructions for Use: Develop clear and comprehensive instructions that guide users on the proper use of the device.

5. Complete the Application Form

• MDACS Application Form: Fill out the official application form provided by the Medical Device Control Office (MDCO).
• Accurate Information: Ensure all information provided is accurate and reflects the technical documentation.

6. Submit the Application

• Compile Submission Package: Include the completed application form, all technical documentation, labeling, and IFU.
• Payment of Fees: Pay the required registration fee as specified by the MDCO.

7. MDCO Review Process

• Initial Application Screening: The MDCO will perform an initial review to check for completeness.
• Technical Evaluation: The MDCO assesses the technical documentation to ensure compliance with regulatory requirements.
• Risk Assessment Review: Review the risk management process and evaluate the effectiveness of risk controls.
• Clinical Data Review: If applicable, assess any clinical evidence provided.
• Labeling and IFU Evaluation: Ensure that labeling and instructions meet regulatory requirements.

8. Respond to MDCO Feedback

• Address Queries: If the MDCO requests additional information or clarifications, respond promptly and provide the requested details.
• Modify Documents if Necessary: Make necessary changes to your application or technical documentation based on feedback.

9. Final Decision and Approval

• Final Review: The MDCO will make a final decision based on the evaluations conducted.
• Approval Notification: You will receive notification of approval or further requirements needed.
• Issuance of Registration Certificate: Upon approval, the MDCO will issue a registration certificate for the device.

10. Post-Registration Compliance

• Post-Market Surveillance (PMS): Implement a PMS system to monitor the device’s performance in the market.
• Adverse Event Reporting: Set up procedures to report any adverse events to the MDCO.
• Maintain Compliance: Ensure ongoing compliance with regulatory requirements and update documentation as needed.

Summary of Key Processes

1. Classification of the Device: Confirm B-class classification.
2. Prepare Technical Documentation: Gather necessary documents.
3. Conduct Risk Assessment: Analyze and document risks.
4. Prepare Labeling and IFU: Ensure compliance with labeling standards.
5. Complete the Application Form: Fill out and verify the application form.
6. Submit the Application: Compile and submit the complete package.
7. MDCO Review Process: Undergo the review and evaluation by MDCO.
8. Respond to MDCO Feedback: Address any queries or required modifications.
9. Final Decision and Approval: Receive notification and registration certificate.
10. Post-Registration Compliance: Implement PMS and maintain ongoing compliance.

By following these processes, you can ensure a thorough and compliant application for B-class medical device registration under MDACS in Hong Kong.

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