On June 3, 2022, the Philippines’ FDA issued Circular No.2017-013-A: amendment To FDA Circular No. 2017-013, titled, “Guidelines On The Issuance of Clearance for Customs Release (CFCR) of Radiation Devices by the Food And Drug Administration – Center For Device Regulation, Radiation Health, And Research (FDA-CDRRHR).” The amendment updates the guidance to align FDA Circular 2017-013 with DOH AO 2018-0002 and to help clarify the Clearance for Customs Release (CFCR) requirements for the industry and at the Bureau of Customs (BOC) for radiation products.
Tag Archive for: guidance
https://asiaactual.com/wp-content/uploads/2017/12/Radiation-equipment.jpg 339 509 Charmaine Roson https://asiaactual.com/wp-content/uploads/2020/08/Growing-Medical-Device-Sales-1030x257.gif Charmaine Roson2022-07-14 18:51:322022-07-14 22:40:34Philippines’ FDA Issues Customs Clearance Guidance for Radiation Products
https://asiaactual.com/wp-content/uploads/2019/08/shutterstock_708369496.jpg 667 1000 Bryan Gilburg https://asiaactual.com/wp-content/uploads/2020/08/Growing-Medical-Device-Sales-1030x257.gif Bryan Gilburg2022-07-08 14:43:222022-07-07 15:50:21NMPA Issues New Guidance for Medical Device Software in China
In March of 2022, the NMPA’s Center for Medical Device Evaluation (CMDE) released new guidance pertaining to registering medical device software in China.