A list of recently published and updated articles regarding medical device regulatory updates from the governing bodies throughout Asia.
Know Your Market Price in Japan
/in Japan, Latest Updates/by AsiaActualAdminJapan should be the second largest national market for your medical device after the United States and maximizing sales performance in Japan should be critical to your overall corporate success. Yet, many manufacturers are frustrated by their results in Japan or struggle to attract the interest of leading distributors. Follow these steps to create a winning market strategy in Japan that will wow investors and leapfrog the competition.
Korea Announces Plans for Unique Device Identification (UDI) Requirements Starting in 2019
/in Latest Updates, South Korea/by Bryan GilburgThe Korean Ministry of Food and Drug Safety (MFDS) published a draft amendment to the Medical Device Act that mandates a new Management System for Controlling Medical Device Information (MCMI) to record information on the overall life cycle of the medical devices from manufacturing to end-use.
India Moves to Online Application Submission System for Medical Device Registration
/in India, Latest Updates/by AsiaActualAdminThe Drugs Controller General of India (DCGI) announced on May 1, 2016 that the SUGAM online application submission system, in use since November 2015 for pharmaceutical registration, would be extended to medical device and IVD device submissions (e.g., registration and import license applications).
Philippines Implements New Customs Clearance Procedure for Radiation Devices
/in Latest Updates, Philippines/by Bryan GilburgRadiation-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)
Increase in Independent License Holder Option in India
/in India, Latest Updates/by AsiaActualAdminMore companies are setting up a subsidiary or using an independent license holder in order navigate the highly rationalized Indian market.
Ablation Devices Now Require Registration in India
/in India, Latest Updates/by AsiaActualAdminThe India Ministry of Health and Family Welfare added ablation devices to the list of notified medical device that require registration.
The Philippines FDA Streamlines Amendment Submission Process
/in Latest Updates, Philippines/by Bryan GilburgOn December 15, 2017 the FDA released guidance that provides for streamlining of the submission process for CPR amendments.
New Office Space for Asia Actual India
/in India, Latest Updates/by AsiaActualAdminAsia Actual is excited to announce the dedication of our new office space in the Delhi area.
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