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- Medical Device Risk Classification Problems in Vietnam May 13, 2024
- Philippines FDA Medical Device Labeling CMDN to CMDR Labeling Guidance May 7, 2024
- Innovative Medical Device Registration in Japan April 30, 2024
- Medical Device Consultation in Japan April 30, 2024
- 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
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India Exempts COVID Test Kits Approved in Reference Countries from Validation Testing
/in India, Latest Updates/by Gunjan VermaAs of April 27th, India’s CDSCO will allow COVID test kits with the following approvals to bypass in-country validation testing. Previously only tests approved by the USFDA (including Emergency Use Authorization) were exempt
Regulatory Spotlight: UDI Requirements in Singapore
/in Latest Updates, Singapore/by Kenna RasiklalSingapore’s Health Science Authority (HSA) has announced that they will follow many countries example and begin implementing a Unique Device Identifier (UDI) system.
Taiwan FDA Increases Regulatory Fees for Medical Devices
/in Latest Updates, Taiwan/by Eric LeungThe Taiwan FDA has announced a price increase for many regulatory items, with some seeing an increase as much as 163%. This notice has been in effect since May 1st, 2021.
COVID Test Kits Now Require In-Country Testing in the Philippines and Indonesia
/in Indonesia, Latest Updates, Philippines/by Charmaine RosonAt this time Indonesia’s Ministry of Health will only regulation Rapid Diagnostic Tests (RDTs) while the Philippines Department of Health will require testing for RDTs, along with other related products such as Nucleic Acid Extraction Kits and COVID-19 antibody tests. It’s expected that the process will require 1-2 months in each country.
Sales Target Spotlight: Philippines’ St. Luke’s Medical Center
/in Latest Updates, Philippines/by Glend LlantadaSt. Luke’s Medical Center (SLMC) in both Quezon City and Taiguig/Global City are top-tier hospitals with Joint Commission International (JCI) accreditation that operate at the quality of international standards. The use of novel technologies for procedures such as 2D and 3D breast ultrasound, laser dermatology procedures, robotic assisted urological surgeries, etc. make SLMC a great target for innovative medical device manufacturers.
India Temporarily Suspends Customs Duties for Covid-19 Related Medical Devices
/in India, Latest Updates/by Gunjan VermaOn Saturday, the Indian Ministry of Finance released a Notification (No. 28/2021–Customs) exempting the following medical devices from customs duties effective immediately until July 31st. The Notification comes as the Indian government continues to take additional steps to battle the ongoing COVID-19 emergency.
Australia’s TGA Continues Alignment with EU Regulations
/in Australia, Latest Updates/by Bryan Gilburgthe TGA made significant changes concerning software, spinal implants, personalized devices, drug administering products, and companion diagnostics that affect many medical device manufacturers. Additionally, the Active Implantable Devices (AIMD) classification will be absorbed into Class III as of November 25, 2021.
Navigating the New Vietnamese Public Medical Device Pricing Portal
/in Latest Updates, Vietnam/by David VoThe new Medical Device Pricing Portal was opened to the public on November 20th with the goal of setting new international standards for medical device sales transparency. The medical device section is split into 2 sections, the Medical Equipment Price and Pricing Information on Winning Bids. On one side, users can view product listings and on the other, review all final government purchases, including contracted pricing.