2024 Recap: Medical Device key Regulation/Guidance in USA, EU, Asia …
U.S. Food and Drug Administration (FDA) issued Update on Artificial Intelligence and Machine Learning in Software as a Medical Device. The paper describes four areas of focus for CBER, CDER, CDRH, …
Medical Device Registration in Asia | Expert Guidance
In this comprehensive guide, we will look at the process of medical device registration in Asia, including an overview of regulatory organizations and regulations, as well as practical advice and insights to …
Medical Device Databases | FDA
Devices@FDA is a catalog of cleared and approved medical device information from FDA. It includes links to the device summary information, manufacturer, approval date, user instructions, and...
Department of Health | Medical Device Division - Search Database
Oct 13, 2022 · Search Database Asian Medical Device Nomenclature System (AMDNS) The List of Medical Devices Thematic Medical Devices The List of Local Responsible Person (LRP) The List of …
Medical Device Regulatory Consulting Services in Asia Pacific
Use our regulatory strategy report to get a head start on planning market entry in Asia or for a regulatory pathway analysis and expert advice on the best place to start given your device’s current regulatory …
Asia Medical Device Compliance: Regulatory Guide | PBM
May 1, 2023 · In this blog post, we’ll explore the critical aspects of medical device compliance in Asia, enabling exporters to navigate the complex landscape and successfully bring their products to the …
Guidance documents for medical devices - HSA
Nov 5, 2025 · Here is the list of guidance documents with relevant forms and templates to help you meet the regulatory requirements for dealing in medical devices.
Medical Device Regulatory Services in Asia Pacific - Freyr Solutions
With an exclusive delivery center in India and a robust existence in the APAC region in coordination with our local affiliates, Freyr brings to you the entire spectrum of Regulatory support for Medical Devices.
Medical Device Regulatory Services in Asia Pacific - JPCI
JPCI offers comprehensive regulatory services to help your medical device business navigate the complex approval processes in APAC markets. Our team provides expert guidance on local …
Ministry of Food and Drug Safety>Our Works>Medical Devices…
MFDS requires those who intend to produce a medical device in Korea, or who intend to import a medical device from overseas to obtain a manufacturing business license and an import business …