Reported by Yang Lien-Gi
After years of negotiation, the amendment of the “Regulations Governing Biotech New Drugs” has passed the third reading in the Legislative Yuan. This amendment revised Article 3 Paragraph 4 of the Regulations to expand the application scope to the Grade 3 medical devices, as well as the Grade 2 medical devices for which clinical trials are required. The government hopes the amendment would encourage more manufacturers to invest in the R&D of high risk medical devices.
The Taiwan Medical and Biotech Industry Association (TMBIA) expressed that this amendment will encourage manufacturers, mainly small and medium enterprises (SMEs), to continue investing in innovation and engaging in the R&D of Grade 2 medical devices which are of high risk and in need of clinical trials. This policy will increase the overall competitiveness of the industry in Taiwan, said the TMBIA.
In fact, many manufacturers have already taken concrete actions to support the government’s determination to increase the industry’s competitiveness. The 3rd reading of the amendment indicates that the industry’s long-term campaign has been acknowledged and supported by the government. The TMBIA appreciates the government’s efforts and good gesture, and hopes that further development can start from here.