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- 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
- Hong Kong MDD Adds China and Korea to List of Reference Countries January 29, 2024
- Thailand FDA to Decrease Registration Application Processing Times January 25, 2024
- Thailand FDA to Improve Medical Device Advertising Review Times January 22, 2024
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Philippines FDA Extends CMDN Deadline to 2024
/in Latest Updates, Philippines/by Charmaine RosonThe Philippines Center for Device Regulation, Radiation Health and Research (CDRRHR) has announced that Certificate of Medical Device Notification (CMDN) applications for non-Notified Class B, C and D Medical Devices will be extended to March 31st, 2024.
India’s CDSCO Releases Guidance for Renewing Medical Device Import Licenses
/in India, Latest Updates/by Gunjan VermaIndia’s CDSCO has issued important guidance on the process for medical device Import License renewal. This process is newly coming into effect, as the first round of Import Licenses issued under the new Rules will start to expire this year.
China Continues to Implement UDI of Medical Devices with Third Batch Release
/in China, Latest Updates/by Bryan GilburgThe NMPA Continues UDI Implementation in China with Third Batch Release announced February 17, 2023 including 103 types of Class II medical devices.
USAID, ANSI and AdvaMed Host Regional Virtual Workshop on Good Regulatory Practices
/in Latest Updates, Philippines/by Charmaine RosonLearn about the recent Virtual Regional Workshop on Good Regulatory Practices and Medical Device Regulation hosted by USAID, ANSI, and AdvaMed. Attendees gained valuable knowledge on navigating the complex world of medical device regulation, including discussions on specific GRPS, WHO global model regulatory framework updates, and country experiences with reliance models. Read on to discover the benefits of recognizing foreign conformity assessment results, transparency, predictability, inclusion, consistency, and accountability.
Vietnam Extends Validity of Medical Device Import Licenses
/in Latest Updates, Vietnam/by David VoOn March 3rd, 2023, the Deputy Prime Minister of Vietnam, Tran Hong Ha, signed Decree No. 07/2023/ND-CP (Decree 07/2023), which automatically extended the validity of import licenses to December 31, 2024.
India Requires Mandatory Local BIS Certifications for Certain Medical Devices
/in India, Latest Updates/by Gunjan VermaThis 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.
Thai FDA Issues Guidance on Specialist Review Selection Criteria
/in Latest Updates, Thailand/by Noi SuwannabotGet the latest insights on the Specialist Review Guidance for medical device registration in Thailand from the Thai FDA. Learn about the criteria that trigger a Specialist Review and how to potentially avoid it.
Philippines FDA to Implement New Guidelines to Respond to Future National Health Emergencies
/in Latest Updates, Philippines/by Charmaine RosonThe Philippines FDA has issued a new report entitled “Guidelines on the Food and Drug Administration’s Regulatory Responses During Declared National or State Public Health Emergencies.”