A list of medical devices that fall within the Class A, Class B, Class C, and Class D categories were included in the 2017 New Medical Device Regulations (MDR). Based on the level of risk they pose, Class A and B devices are categorized as low-risk and moderate-risk devices, respectively, whereas Class C and D devices are classified as high-risk and extremely high-risk devices, respectively.
- April 6, 2023 Medical Devices, Regulatory Affairs
- April 5, 2023 Medical Devices, Regulatory Affairs
The driving factors behind the medical device industry are still evolving, as the Gulf Cooperation Council (GCC)’s healthcare expenditure is rising dramatically. To maintain this trajectory, The GCC has developed a portal called Taawon to facilitate the registration and approval of drugs and medical devices in GCC countries.
- April 5, 2023 Medical Devices, Regulatory Affairs
Medical device manufacturers must complete the Gulf Cooperation Council (GCC) medical device registration process to sell their products in Bahrain, Kuwait, Oman, Qatar, Saudi Arabia, and the United Arab Emirates (UAE). The registration procedure ensures that the medical devices sold in these countries adhere to the essential quality and safety requirements as well as the relevant regulations.
- March 27, 2023 Food and Food Supplements, Regulatory Affairs
Claims are a vital aspect of marketing food and dietary supplements, as they help consumers understand accurate details of the product. In the United States of America (USA), food and dietary supplement products are regulated by the United States Food and Drug Administration (US FDA).
- March 24, 2023 Medical Devices, Regulatory Affairs
What is an RTA?
In the context of medical device Regulatory Affairs, a Refusal to Accept (RTA) is a request from the US FDA for additional information or clarification on information submitted in a 510(k) application.
- March 24, 2023 Medical Devices
The development of In-Vitro Diagnostic (IVD) devices is a classic example in the healthcare sector, where modern technology has enabled healthcare professionals to improve treatment regimes for serious life-threatening health conditions. While Regulatory agencies worldwide are working towards harmonized regulations to market IVDs, China’s NMPA has led to stringent guidelines for the regulation of IVDs in China market.
- March 24, 2023 Medical Devices, Regulatory Affairs, Regulatory Medical Writing
The analytical performance is described in European Union In Vitro Diagnostic Regulations (EU IVDR) 2017/746 as “the ability of the device to correctly detect or measure a particular analyte.” The analytical performance of any IVD/s is demonstrated based on the analytical performance studies, which are then documented as Analytical Performance Report (APR).
- March 24, 2023 Medical Devices
A Scientific Validity Report (SVR) is a part of the Performance Evaluation Report (PER) under the European Union In Vitro Diagnostic Devices Regulations (EU IVDR) 2017/746 that documents the scientific validation of the IVDs. The SVR supports the device's conformity assessment and for the same one must consider any relevant published literature and standards.
- March 21, 2023 Medical Devices
The European Union Medical Device Regulation (EU MDR) 2017/745 is a regulation that sets out the requirements for medical devices in the EU. The regulation provides the evaluation of medical devices prior to marketing, and one of the key requirements is the need for clinical investigations.
- March 21, 2023 Medical Devices
As stated in the European Union Medical Devices Regulations (EU MDR) 2017/745, clinical investigation, is “any systematic investigation involving one or more human subjects, undertaken to assess the safety or performance of a device” The entire purpose of clinical investigations is to demonstrate that medical devices are safe and effective when used for their intended purpose.