Tag Archive for: importing

India Issues New Sales License Requirement for Medical Devices

On September 30th, 2022, the Indian Ministry of Health and Family Welfare (MOHFW) issued GSR 754(E) announcing new sales license requirements for entities importing and distributing formerly non-notified medical devices.

India Requires Mandatory Local BIS Certifications for Certain Medical Devices

This blog serves as an important enforcement notice for manufacturers/importers that BIS certification is required for some of the electronic components/accessories included in medical devices, including batteries, monitors, power adaptors and more.

Philippines’ FDA Issues Customs Clearance Guidance for Radiation Products

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.