As a major step for the reproductive rights of women, Japan’s Health Ministry approves the first abortion pill in its history. Following multiple deliberations and debates over the controversial rules of consent, Japanese women are now allowed to seek safe abortions. It is also celebrated by medical experts online as an opportunity to increase better sex education and awareness.
- May 19, 2023 Pharmaceuticals, Regulatory Affairs
- May 18, 2023 Medical Devices
In India, a medical device test license, issued by the Central Drugs Standard Control Organization (CDSCO),. is a license which allows the manufacturer to manufacture or import small quantity of medical device for the purpose of clinical investigations, tests, evaluations, demonstrations, or training and to gather data on its safety and efficacy.
- May 18, 2023 Medical Devices
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
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.