510(k) is a premarket submission made to the FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent to a legally marketed device (predicate). Devices with moderate risk are required to submit a 510(k) notification, which includes a minority of Class I and III devices and a majority of Class II devices.
- November 24, 2022 Medical Devices, Regulatory Affairs
- November 24, 2022 Medical Devices, Regulatory Affairs
Class A IVDs under European Union In Vitro Diagnostic Devices Regulations (EU IVDR) 2017/745 require self-certification. The manufacturer is required to self-declare their product’s compliance with the EU IVDR’s requirements and affix the CE marking.
- November 24, 2022 Medical Devices, Regulatory Affairs
What is an eCopy?
An eCopy is an electronic version of your medical device submission created and submitted on a compact disc (CD), digital video disc (DVD), or flash drive. An eCopy is accompanied by a paper copy of the signed cover letter. It is to be noted that an eCopy is not the same as a Food and Drug Administration (FDA) electronic submission [PKJ1]. Following are submissions that require an eCopy:
- November 22, 2022 Medical Devices, Regulatory Intelligence, Regulatory Software & Services
The medical device industry is undergoing continuous transformation to comply with the ever-changing Regulatory guidelines introduced by global Regulatory authorities to ensure strict controls over device performance and safety.
- November 22, 2022 Medical Devices, Regulatory Affairs
The need for continuous improvement in product quality, reliability, and safety arises due to recalls, updates of Regulatory requirements, and the desire to gain a competitive advantage. The newly introduced changes may alter the risk profile of the device, and the device manufacturers must revisit risk evaluations that pinpoint and reduce part or system failures over the product's lifecycle.
- November 21, 2022 Biologicals, Generics, Pharmaceuticals
DYK? The National Medical Products Administration (NMPA), along with China National Intellectual Property Administration (CNIPA), has released “Measures for the Implementation of Early Resolution Mechanisms for Drug Patent Disputes (Trial)." It is a patent registration platform for chemical drugs, biological products, and traditional Chinese medicines.
- November 21, 2022 Medical Devices, Regulatory Affairs
With the enactment of NMPA’s Regulations on the Supervision and Administration of Medical Devices - Order 739 in 2021, the medical device registration process in China has undergone substantial changes. The NMPA has implemented several process-related changes to streamline and improve the device registration process.
- November 17, 2022 Medical and Scientific Communication, Regulatory Medical Writing
The Committee on Publication Ethics (COPE) was established in 1997 to address research and publishing ethics violations. Its goal was to identify workable solutions to the problems and create best practices. It is a non-profit organization that offers a discussion forum and guidance to scientific editors.
- November 16, 2022 Regulatory Artwork Services, Regulatory Affairs, Regulatory Labeling
As the world is moving towards digital transformation, the introduction of various tools is empowering many industries, including Pharmaceuticals and Life Sciences. In fact, the serialization and traceability of items can be improved even further as the world transitions to a digital economy.
- November 16, 2022 Medical Devices, Regulatory Affairs
Brazil is the largest economy in Latin America and the most promising medical device market. Medical device market in Brazil is governed by the Brazilian Health Regulatory Agency, ANVISA. The ANVISA came up with a new resolution, RDC 687/2022, for granting or renewing the Brazilian Good Manufacturing Practice (BGMP) certification for medical devices and is in effect from June 01, 2022, annulling RDC 183/2017.