A list of recently published and updated articles regarding medical device regulatory updates from the governing bodies throughout Asia.
Radiation-emitting medical devices such as X-ray machines, MRIs, linear accelerators and ultrasound scanners are now subject to a new customs clearance release procedure administered by the Philippine Food and Drug Administration (FDA)
More companies are setting up a subsidiary or using an independent license holder in order navigate the highly rationalized Indian market.
The India Ministry of Health and Family Welfare added ablation devices to the list of notified medical device that require registration.
On December 15, 2017 the FDA released guidance that provides for streamlining of the submission process for CPR amendments.
Asia Actual is excited to announce the dedication of our new office space in the Delhi area.
The new Medical Device Rules, 2017 that took effect January 1, 2018 significantly expands the number of IVD devices requiring full technical documentation in support of their Import License applications.
This month, the Center for Device Regulation, Radiological Health and Research (CDRRHR) has relocated from the Department of Health in Manila to new facilities within the FDA central compound in Alabang.
President Rodrigo Duterte appointed Charade Galang-Puno as the new Director General of the Philippines Food and Drug Administration. Dr. Galang-Puno is one of 42 appointees sworn in on Monday, August 15 at the Malacañang Palace in Manila.
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