Electronic Labeling (e-labeling) is a medical device labeling alternative to traditional paper labeling. It entails the use of electronic media such as CD-ROMs, DVDs, or websites to provide consumers/users with label information. There are numerous benefits of e-labeling in the medical device industry. The most significant advantages are the following:
- May 18, 2023 Medical Devices
- May 18, 2023 Medical Devices
What is Loan License for a Medical Device?
A loan license is issued by the State Licensing Authority (SLA)/Central Licensing Authority (CLA) for manufacturing medical devices; it is an agreement between two manufacturers who grant the right to use their facilities and infrastructure for manufacturing the device.
- May 18, 2023 Medical Devices
An installation guide is a type of technical document that the device manufacturer provides during medical equipment installation. It contains instructions on how to install software, hardware, or any other components that need to be assembled.
- May 18, 2023 Food and Food Supplements, Regulatory Affairs
In South Korea, food and dietary supplement regulations are governed by the Ministry of Food and Drug Safety (MFDS) and are also referred to as health/functional foods (HFF).
- May 17, 2023 Medical Devices
Quality Management System (QMS) is an essential component of the medical device industry, ensuring the safety, efficacy, and Regulatory compliance of medical devices throughout their lifecycle.
- May 17, 2023 Medical Devices
The European Union's (EU) Medical Device Regulation (MDR) has been making news for a while now. The MDR has replaced the Medical Device Directive (MDD) and Active Implantable Device Directive (AIMDD). Initially, the entire transition was set out to be in complete effect by May 2020; however, due to the emergence of the COVID-19 pandemic, the implementation was pushed further to May 26, 2021.
- May 17, 2023 Medical Devices, Regulatory Affairs
IVD devices are essential for healthcare professionals in providing accurate and timely diagnosis, monitoring, and treatment of diseases, leading to improved patient outcomes and better public health. IVD devices are classified into different classes based on their level of risk to the patient and the complexity of the device. The classification system for IVD devices varies depending on the region or country.
- May 17, 2023 Medical Devices, Regulatory Affairs
Artificial Intelligence (AI) has the potential to revolutionize the healthcare industry by improving the accuracy, efficiency, and speed of diagnosis and treatment. However, the development and deployment of AI medical devices also pose significant Regulatory challenges. In response, China's National Medical Products Administration (NMPA) has issued guidelines for registering and reviewing AI medical devices.
- May 17, 2023 Medical Devices
The Unique Device Identification (UDI) system is an international standard that assigns a unique code to each medical device to improve patient safety and streamline product tracking and recall. In China, the National Medical Products Administration (NMPA) has implemented UDI guidelines and regulations for medical devices to enhance safety and quality control.
- May 15, 2023 Pharmaceuticals, Regulatory Labeling
Abbreviated SmPCs (Summary of Product Characteristics) form an important source of information for healthcare professionals and patients alike. These documents provide a summary of key information about a medicinal product, including its indications, posology, contraindications, and adverse reactions.