Certificated Training Course on Medical Device Clinical Trial and Regulatory for New Medical Product Development

By Ms Crystal CHUI and Ms Vivian CHOW

Organized by the Hong Kong Productivity Council (HKPC) and supported by BM Division, the captioned Training Course was held on 5-6 February 2015 at HKPC. The training course provided an in-depth overview of the procedures and considerations on clinical studies’ perspectives in medical device development process and knowledge on clinical trial design and monitoring.

The first speaker on Day 1, Ir Bryan SO, Principal Consultant of Biomedical, Optical and Precision Engineering Unit of HKPC, highlighted the global trends of clinical trials and introduced international regulatory affairs related to testing and evaluation of medical device. The second speaker, Ms Mandy YIP, Associate Consultant of HKPC outlined the medical device approval process to the participants. She presented the major elements in the approval process including the categorization of medical device, premarket notification and premarket approval. By sharing the practical case study on the development of skin cancer detector, the third speaker, Ms Carol LIU, Associate Consultant of HKPC introduced the standards and specifications of clinical trial for bio-optics technology development.

On day 2, Mandy continued to introduce the pre-study processes of clinical trial by sharing the criteria for investigator selection and the procedures for conducting pre-investigation visit. Mandy also shared her knowledge on adverse event terminology and the obligations related to adverse event reporting. The final speaker, Mr Henry FONG, Associate Consultant of HKPC shared the procedures for conducting human clinical trial during the development of artificial finger joint. The procedures included the preparation of human clinical trial protocol for Institutional Review Board (IRB) approval, maintenance of case report form (CRF), organization of subject recruitment talks, pre-operative screening and post-operative assessment.

With various discussions and training exercises in the training course, participants gained a better understanding on the specific requirements in clinical trials and Good Clinical Practice (GCP), which enabled medical devices manufacturers, inventors, researchers and local regulatory personnel to acquire new knowledge on the related approval procedures for the development of medical devices that involve clinical evaluation.