Effective July 1, devicemakers seeking to register products in Taiwan will need to have their quality system documents approved before submitting an application.
Under the program, applicants will need to undergo a review of administrative documents within 10 days of submission, including application forms, QSD approval letters, authorization letters, and certificates to foreign governments or certificates of free sale, says Stewart Eisenhart, senior regulatory analyst with Emergo Group.
Applicants sometimes are accepted without QSD approval letters, he says. The Taiwan Food and Drug Administration’s new process will involve review of preclinical safety and performance tests for Class II and III devices, and facility quality control documentation.
The changes bring the system closer in line with the Asian Harmonization Working Party, says Seth Goldenberg, director of global regulatory strategy at NAMSA. Most importantly for innovative companies, the new process will let them leverage overseas approvals, he tells IDDM.
Registration fees will increase, but figures are not available. — Jonathon Shacat