THE SGS FDA 3P510(K) PROGRAM

THE SGS FDA 3P510(K) PROGRAM

• Introduction: Through the SGS third-party notified body, review the medical devices with lower risk levels, so that the FDA can focus more on the review of high-risk medical devices to ensure the safety and efficacy of medical devices on the market.

• Application process: The manufacturer confirms whether the medical device applied for is an item in the SGS third-party review list ⇒ Fill out the questionnaire to apply ⇒ SGS review the feasibility and complete the level acceptance analysis ⇒ Open the schedule review

• Applicable customer: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfThirdParty/current.cfm

Knowledge Department - Taipei
FAX
02-22993231
ADD
No. 38, Wuquan Rd., Wugu Dist., New Taipei City 248016 , Taiwan
Knowledge Department - HsinChu
ADD
1F, No. 286, Sec. 1, Wenxing Rd., Zhubei City, Hsinchu County 302053 , Taiwan
Knowledge Department - TaiChung
FAX
04-23592032
ADD
No. 2, Gongyequ 41st Rd., Xitun Dist., Taichung City 407019 , Taiwan
Knowledge Department - KaoHsiung
FAX
07-3012263
ADD
No. 600-11, Jiachang Rd., Nanzi Dist., Kaohsiung City 811646 , Taiwan