전체 글9 Best way to prepare KGMP which is Korea GMP? What is the KGMP? K-GMP(Korea Good Manufacturing Practices) certification is a critical requirement for manufacturers of medical devices seeking entry into South Korea’s market. Overseen by the Ministry of Food and Drug Safety (MFDS), this certification ensures that manufacturers comply with quality and safety standards specific to the country. Whether you are a domestic producer or a foreign ma.. 2024. 12. 3. Vietnam, How fast can we register medical device? Providing 2 Important Tips Vietnam Market IntroductionIf you are looking for market that you can easy to access or export, you should definitely consider Vietnam.Vietnam is one of Asia's rising stars, playing a significant role in the region. From its growing population to its economic significance, Vietnam stands out as a dynamic and rapidly evolving country. Here's brief comparison between Vietnam and other nations in A.. 2024. 11. 23. Medical device FDA Fee for 2025, how much and who should pay? To registor medical device to US, we need to start with establishment registration. Let's see all about FDA fee to register your device. IntroductionTo get FDA's medical device registration process involves understanding and budgeting for various fees. These fees are essential to comply with the U.S. Food and Drug Administration (FDA) regulations and ensure that your medical device can legally e.. 2024. 11. 21. FDA Initial Registration - Complete guide for medical device & FDA registration A complete guide to initial FDA registration introduction If you're a medical device manfuacturer planning to enter the U.S. market, FDA registration is a critical first step. The process ensures that your device meets the regulatory requirements of the Food and Drug Administration (FDA) and can be marketed legally. Navigating the registration process can seem daunting, but with the right guidan.. 2024. 11. 21. Understanding EUDAMED: Access, Functionality, and Search Capabilities What is EUDAMED?EUDAMED (European Database on Medical Devices) is a key component of the EU's regulatory framework for medical devices, established under the Medical Devices Regulation (MDR) (Regulation (EU) 2017/745) and the In Vitro Diagnostic Medical Devices Regulation (IVDR) (Regulation (EU) 2017/746). It is designed to enhance transparency, traceability, and coordination among stakeholders .. 2024. 11. 20. MDCG vs. MEDDEV: Understanding the Evolution of EU Medical Device Guidance What is MDCG ?The MDCG (Medical Device Coordination Group) guidelines under MDR 2017/745 provide detailed guidance on implementing and complying with the Medical Device Regulation. These documents cover various aspects such as classification, conformity assessment, clinical evaluation, post-market surveillance, and more. The Medical Device Coordination Group (MDCG) is a body established under Ar.. 2024. 11. 20. 이전 1 2 다음
