Search Our News
Latest Headlines
- 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
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
Thai FDA Improves Medical Device Application Process
/in Latest Updates, Thailand/by Noi SuwannabotIn a virtual meeting held June 19, 2023, the Thai Food and Drug Administration (TFDA) discussed several measures aimed at enhancing the management of medical device registration applications. Standing out was the new Regulatory Applicant (RA) program which provides expedited reviews to applications submitted by certified RA’s and the possibility of utilizing External Expert Bodies as an additional review resource.
Hong Kong Government Prioritizes Purchase of Locally Registered Medical Devices
/in Hong Kong, Latest Updates/by Albert PranotoThe Department of Health (DH) in Hong Kong has announced a new strategy for the procurement of medical devices (MDs), effective from June 21, 2023.
Vietnam Adjustments to the Medical Device Application Requirements
/in Latest Updates, Vietnam/by David VoVietnam has recently made significant amendments to its medical device registration process and technical documentation requirements. The Ministry of Health (MOH) issued Circular 10/2023/TT-BY on May 11, 2023, outlining the new guidelines for pre-market approval.
An Introduction to GeM, India’s Online Portal for All Public Hospital Purchases
/in India, Latest Updates/by Albert PranotoIn 2016 the Indian government launched an online portal, the Government e-Marketplace (commonly referred to as GeM) under the Ministry of Commerce and Industry to provide for efficient and transparent procurement by government agencies across the country.
Vietnam Diagnostic Imaging Center Hosts AI Software Conference
/in Latest Updates, Vietnam/by David VoOn April 15th the MEDLATEC Diagnostic Imaging Center (MEDIM) hosted a conference to discuss the current state of AI-based software in diagnostic imaging in Vietnam.
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.