Bundang Seoul National University Hospital holds on-site regulatory consultation with food and drug safety ministry

Bundang Seoul National University Hospital's Biomedical Research Institute held an on-site pre-consultation session Monday at its Healthcare Innovation Park in partnership with the Ministry of Food and Drug Safety's pre-consultation division.

The on-site pre-consultation program was established by the Ministry of Food and Drug Safety to give companies hands-on guidance from regulatory experts on licensing issues that arise during medical device development. Bundang Seoul National University Hospital became the first research-focused hospital to launch a collaborative project with the ministry last year, and Monday's session marked the third such consultation under that partnership.

Participating companies were able to consult directly with ministry review experts on whether the scope and requirements of their submission materials were adequate for clinical trial plan approval or product license applications. The sessions allow companies to identify regulatory requirements in advance, helping them bring products to market more smoothly.

Choi Byung-yun, head of research planning at Bundang Seoul National University Hospital, said the sessions have proven increasingly valuable as regulatory standards grow more complex. "As licensing and review criteria become more sophisticated, the ability to accurately understand the relevant requirements and respond to regulations is becoming ever more important," he said. "The three rounds of on-site consultations have been a great help to in-hospital startup founders and resident companies in building their early-stage licensing strategies."

Meanwhile, the hospital's Biomedical Research Institute became the first tertiary general hospital to obtain GMP certification under the Digital Medical Products Act and ISO 13485 international certification in the AI medical device manufacturing and consulting sector. The institute also supports regulatory science broadly — including digital medical device licensing — through its Medical Device Research and Development Center, and backs startup founders from early-stage launch through commercialization via a business incubation center designated by the Ministry of SMEs and Startups.