Search Our News
Latest Headlines
- 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
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
China NMPA Adds 47 Products to Clinical Trial Exemption List
/in China, Latest Updates/by Albert PranotoChina’s National Medical Products Administration (NMPA) updated its clinical trial exemption list, adding 47 products. The NMPA updates this list every two to three years, with the last amendment in 2021. This brings the total number of clinical trial exempted product categories in China to 1,025.
New Plastic Waste (PWM) Rules Affect Medical Device Importers in India
/in India, Latest Updates/by Gunjan VermaIndia’s Pollution Control Board (CPCB) has issued an update on plastic packaging and Plastic Waste Management (PWM) requiring importers quantify the type of plastics being imported through a brief registration process.
China to Regulate Medical Device Advertising
/in China, Latest Updates/by Albert PranotoChina is developing new standards and processes for the regulation of advertising for medical devices (as well as pharmaceuticals, food supplements and cosmetics). The goal is to maintain the order of the advertising market, standardize the review of advertisements and protect the rights and interests of consumers.
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.