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- Australia’s SaMD Regulatory Deadline April 16, 2024
- Thai FDA Regulatory Documentation Exemptions April 12, 2024
- Hong Kong MDD Adds Singapore as Reference Country April 4, 2024
- Philippines Incentivizing Local Medical Device Manufacturing March 19, 2024
- China’s Third Batch of UDI Implementation Deadline in June March 15, 2024
- Thai FDA Reduces Application Review Time March 13, 2024
- Vietnam’s MoH Updates Class C and D Application Requirements February 29, 2024
- India Changes Medical Device Application Processing System February 27, 2024
- India’s Class C and D Import License Enforcement Deadline Fast-Approaching February 20, 2024
- Thai FDA QMS Updates to Affect GDP, GMP, and GCP February 14, 2024
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Philippines Announces New Medical Device Regulations
/in Latest Updates, Philippines/by Bryan GilburgIndonesia the Next to Takes Steps Toward ASEAN MDD Harmonization
/in Indonesia, Latest Updates/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)