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- Hainan Island’s Special Access Program for Medical Devices August 2, 2024
- China Updates Medical Device Clinical Evaluation Pathway Guidance July 29, 2024
- China Releases New List of Standards for Medical Device Registration July 26, 2024
- Key Takeaways from VietNam’s CSDT Conference July 12, 2024
- Hong Kong Increases Prioritization of Registered Medical Devices July 12, 2024
- TGA Emphasizes Medical Device Distribution Record-Keeping July 10, 2024
- Singapore’s HSA Increases Medical Device Registration Fees July 2, 2024
- TGA Updates Rules for Medical Device Manufacturers June 25, 2024
- Software as a Medical Device in Thailand June 17, 2024
- Hong Kong Prepares Office for Mandatory Medical Device Regulations June 14, 2024
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Medical Device Risk Classification Problems in Vietnam
/in Latest Updates, Vietnam/by David VoAccording to a report published on May 7th, 2024, contractors have been apprehended misrepresenting IVD and Medical Device risk classification to participate in bidding parties.
Philippines Issues Guidance on Medical Device Labeling
/in Latest Updates, Philippines/by Charmaine RosonOn April 5th, the CDRRHR provided guidance for CMDR medical device labeling in the Philippines related to previously CMDN labeled stock.
Innovative Medical Device Registration in Japan
/in Japan, Latest Updates/by Bryan GilburgIn 2019, Japan’s Ministry of Health, Labor and Welfare (MHLW) and Pharmaceuticals and Medical Devices Agency (PMDA) introduced a innovative device registration designation system, called Sakigake, which is meant to streamline the regulatory pathway for qualifying medical products.
Medical Device Consultation in Japan
/in Japan, Latest Updates/by Bryan GilburgMedical device consultation in Japan is a very involved but essential process in registering a medical device. A significant part of the regulatory process in Japan is consultation meetings with the Pharmaceuticals and Medical Devices Agency (PMDA).
Australia’s SaMD Regulatory Deadline
/in Australia, Latest Updates/by Bryan GilburgBeginning on November 1st, 2024, Australia’s Therapeutic Goods Administration will implement new rules surrounding software as a medical device (SaMD). While some SaMD will require additional regulatory requirements, other SaMD will be exempted from some, or excluded completely, from the new regulations.
Thai FDA Regulatory Documentation Exemptions
/in Latest Updates, Thailand/by Noi SuwannabotMarch 12, 2024: the Thai FDA released draft guidance updating the list of required documentation for Full and Concise Evaluation. For manufacturers registering a medical device in Thailand, certain documents are no longer required.
Hong Kong MDD Adds Singapore as Reference Country
/in Hong Kong, Latest Updates/by Bryan GilburgStarting April 2nd, 2024, the Hong Kong Medical Device Division (MDD) accepts, on a regular basis, the marketing approvals obtained from the the Health Sciences Authority (HSA) of Singapore as a support of compliance of medical device to the “Essential Principles of Safety and Performance of Medical Devices” (Technical Reference: TR-004) under MDACS.
Philippines Incentivizing Local Medical Device Manufacturing
/in Latest Updates, Philippines/by Glend LlantadaOn March 14th, 2024, the Philippines FDA announced plans to accelerate medical device and pharma manufacturing through proposed ecozones.