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- CDSCO Issues Updates to IVD Classification List in India November 29, 2023
- Embracing Innovation and Collaboration: Highlights from the 15th CII Global MedTech Summit November 2, 2023
- Bangladesh LAUNCHES NEW MEDICAL DEVICE REGULATIONS October 17, 2023
- India Grants Import License Grace Period for Class C/D Devices October 16, 2023
- Indonesia to Require Post-Market In-Country Testing of Medical Devices October 11, 2023
- China’s NMPA Updates Medical Device Classification Catalogue September 19, 2023
- Thai FDA Drafting New Guidance for SaMD and AI Device Registration September 18, 2023
- China NMPA Adds 47 Products to Clinical Trial Exemption List August 22, 2023
- New Plastic Waste (PWM) Rules Affect Medical Device Importers in India August 22, 2023
- China to Regulate Medical Device Advertising August 2, 2023
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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 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.