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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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India CDSCO Alerts Manufacturers to Non-Notified Class C and D Deadline
/in India, Latest Updates/by Gunjan VermaOn October 1st 2023, the India CDSCO will enforce full license requirements for Class C and D non-notified medical devices as the final step of transitioning all medical devices under the new rules.
China CMDE Supplementary Documents Submission Deadline Extended
/in China, Latest Updates/by Albert PranotoOn February 20th, 2023, China’s Center for Medical Device Evaluation (CMDE) issued new guidance extending the response deadline to requests for supplementary documents to 12 months.
UDI Labelling Mandatory for Certain Taiwan Medical Devices
/in Latest Updates, Taiwan/by Albert PranotoIn Taiwan, beginning June 1st, 2023, manufacturers of Class II medical devices will need to ensure products placed on the market have compliant Unique Device Identification (UDI) labeling.
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 September 30, 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.