It is well-known that Unique Device Identification (UDI) is critical, and if implemented accurately, it will garner major and long-term benefits for medical device manufacturers, healthcare providers, and consumers.
- December 20, 2021 Medical Devices
- December 17, 2021 Medical Devices
A 510(k) submission for medical devices is a mandatory process to receive market clearance in the USA. While the submission process may not be onerous, figuring out where and how to begin can be daunting. However, the US FDA provides ample information in its guidance documents to assist the medical device manufacturers for a smooth 510(k) submission.
- December 17, 2021 Medical Devices
Intending to curb the spread of COVID-19, the MHRA extended the free PPE (Personal Protective Equipment) scheme, which was initially introduced in March 2020. The scheme intends to protect the health and social care providers, and community pharmacies, and public sector organizations from COVID-19, by providing easy access to PPE in the volume required.
- December 16, 2021 Medical Devices
Software and Artificial Intelligence (AI) play an important role in the medical device sector, with a fast-developing and wide set of applications in the health care system. Most of the applications will be regulated as medical devices and can range from screening to diagnosis to treatment and management of chronic conditions.
- December 16, 2021 Medical Devices
Over the past few decades, the use of software has drastically advanced and brought about rapid changes in the medical device industry. The increasing importance of software in medical devices and the patient’s experience is crucial for further developments. However, SaMD has challenges for both regulators and the medical device industries alongside the new opportunities.
- December 15, 2021 Publishing & Submissions, Regulatory Software & Services
The world of Life Sciences is ever-changing and becoming more challenging, with fast-paced Regulatory guidelines being introduced frequently. Over the last decade, Health Authority (HA) guidelines have seen a manifold increase. In the current scenario, companies must adopt smart, modular & intelligent solutions in developing products to ensure global market reach and compliance.
- December 15, 2021 Regulatory Affairs, Publishing & Submissions, Health Authority Updates
Marketing Authorization Holders (MAHs) in the United Kingdom were provided and asked to submit any/all data and related information for all converted licenses in the electronic Common Technical Document (eCTD) format within just one (01) year starting from January 01, 2021.
By that timeline, if the renewal application is not submitted before December 31, 2021, the license will be considered canceled.
- December 15, 2021 Pharmaceuticals, Registration Strategy, Market Access
Supply chain challenges across the globe have laid bare the inefficiencies of the distribution system framework amidst the pandemic. Considering its enduring impact on the global pharmaceutical market, better operational structure and resilient operational framework are the basis for seamless manufacturing requirements in hindsight.
- December 15, 2021 Pharmaceuticals, Regulatory Affairs, Regulatory Consulting
Applicants often misunderstand the scope of the meetings with the Medicines and Healthcare products Regulatory Agency (MHRA) and fail to comply with the legislative requirements of such meetings. These misunderstandings create prejudice against the procedure and affect the success rate of the meetings.
Scientific advice meetings with the MHRA can be held in the following phases.
- December 10, 2021 Medical Devices
With the development of technological advancements, there is an increase in the usage of network connection technology for medical devices. The connected medical devices store and transmit the patient data and demand both privacy and accuracy. Therefore, the cybersecurity of medical devices will continue to be in focus for regulators and manufacturers.