Job Summary

Main Responsibilities (Key Responsibilities)

1. LRP Local Responsible Person (LRP) Application & Setup

• According to the MDD guidance of the Health Department, assist the company and its designated internal personnel in opening and establishing an LRP account in the "Medical Device Information System (MDIS)".

• Prepare and organize the official documents required for LRP application, including: Manufacturer's LRP Appointment Letter, Business Registration Certificate (BR) and related statement, etc.

2. Medical Device Application Submission (MDACS Product Listing via MDIS)

• Operate the MDIS computer system, execute the product listing application for general medical devices (GMD) or in vitro diagnostic medical devices (IVDMD).

• Interface with overseas/local manufacturers, collect and review a full set of technical files, including:

  • Designate a reference jurisdiction for sales approval (US FDA, EU CE, Chinese NMPA, etc., Route 1) or CAB certification certificate (Route 2)

  • ISO 13485 Quality Management System Certificate

  • Clinical evaluation report (GMD) or performance evaluation report (IVDMD)

  • Product labels, packaging samples, and user instructions (IFU)

• Act as the official communication window between the company and the Medical Devices Department (MDD) of the Health Bureau.

• Responsible for following up on the progress of the audit and responding to technical inquiries from the auditors within the specified time limit and supplementing relevant information.

Entry Requirements (Requirements & Qualifications)

• Education: Hold a diploma or bachelor’s degree in biomedical engineering (Biomedical Engineering), life sciences, medical science, pharmacy or regulatory affairs (RA) related subjects.

• Practical experience: Have at least 1 year of practical experience in handling Hong Kong Department of Health Medical Device Application (MDACS Listing) or LRP application.

• System Familiarity: Familiar with the Hong Kong Department of Health's MDD guidance, and with experience in operating the MDIS computer application system.

• File capability: Have excellent Chinese and English reading and writing abilities, be able to carefully read overseas manufacturers' English technical files (Technical Files) and integrate them.

Prioritization:

• Preference will be given to those who have successfully assisted institutions or internal personnel in completing LRP account establishment and successfully obtaining product listing numbers.