Search Our News
Latest Headlines
- China Continues to Implement UDI of Medical Devices with Third Batch Release March 16, 2023
- USAID, ANSI and AdvaMed Host Regional Virtual Workshop on Good Regulatory Practices March 7, 2023
- Vietnam Extends Validity of Medical Device Import Licenses March 7, 2023
- India Requires Mandatory Local BIS Certifications for Certain Medical Devices February 22, 2023
- Thai FDA Issues Guidance on Specialist Review Selection Criteria February 16, 2023
- Philippines FDA to Implement New Guidelines to Respond to Future National Health Emergencies February 7, 2023
- Hong Kong Refines Medical Device Post-Market Surveillance Report Form January 27, 2023
- Thailand FDA Provides Guidance on Classification of Physical Therapy Devices January 19, 2023
- Philippines FDA Issues Advisory Reiteration Against Unethical Business Practices January 13, 2023
- Indonesia e-Catalogue Implementation Review, December 2022 December 30, 2022
Blogs by Country
実際の亞洲
เอเชีย แอคชวล
एशिया वास्तविक
실제 아시아
Asia Actual, LLC
515 Congress Avenue, Suite 2100
Austin, TX 78701
+1 512 898-9222
Contact Us
Privacy Policy
Asia Headquarters
116 Changi Road, #04-05
Singapore 419718
+65 8800-3197
Asia Actual Expands into Russia
/in Latest Updates, Russia/by Bryan GilburgIndia to Require Ultrasound and Imaging Equipment to be Registered with the CDSCO
/in India, Latest Updates/by Bryan GilburgNew Regulations in India Raise the Bar for Many IVD Devices
/in India, Latest Updates/by Bryan GilburgThe 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.
Indonesia Publishes Guidelines for Clinical Trail Approvals for Medical and Diagnostic Devices
/in Indonesia, Latest Updates/by Bryan GilburgThe 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.
India’s New Medical Device Rules Launched on Schedule
/in India, Latest Updates/by Bryan GilburgPhilippines 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)
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.