The FDA has introduced “Safer Technologies Program for Medical Devices (STeP)” in line with the “Breakthrough Devices Program”, to facilitate timely access to certain devices and device-led combination products.
- January 25, 2021 Medical Devices, Regulatory Affairs
- January 19, 2021 Regulatory Affairs, Regulatory Medical Writing
Clinical and nonclinical research programs demand the development of high-quality documents for timely submissions and approval of the drug product from Regulatory authorities. Medical writing plays a crucial role in drafting all the necessary documents right from drug development through submission and approval.
- January 18, 2021 Cosmetics Regulatory Services, Regulatory Affairs
Due to the growing young population in the country, the cosmetics market of India is proven to be lucrative for manufacturers across the world. The continuous evolution of the industry is driven by the growing awareness of the consumers about their personal care needs, thus, fuelling the demand for local as well as internationally manufactured innovative products.
- January 8, 2021 Chemicals
Chemical mixture importers and downstream users in the EU are obliged to comply with Article 45 to the Classification, Labelling and Packaging (CLP) Regulation if their mixture bears physical or human health-hazardous classification.
- January 5, 2021 Medical Devices, Regulatory Affairs
Medical device industry has been a booming industry with new technologies being introduced from time to time and has been dynamic in terms of Regulatory landscape. The year 2020 has seen a major disruption due to the COVID-19 Pandemic and demanded the Health Agencies to gear up for addressing the pressing situation, thus impacting the Agency’s plan of action.
- January 5, 2021 Medical Devices, Regulatory Affairs
The US FDA continues to release and update the guidelines and enforcement policies for efficient management of the device Regulatory affairs in the USA, alongside handling the emergency health situation that surfaced due to the COVID-19 pandemic.
- January 5, 2021 Medical Devices, Regulatory Affairs
The MDCG (Medical Device Coordination Group) has released a position paper on UDI assignment to assist the manufacturers of spectacle lenses and ready readers about the obligations under the EU Medical Device Regulations (EU MDR) 2017/745. It also has the details to be considered while assigning an UDI (Unique Device Identification) to these devices.
- December 23, 2020 Medical Devices, Compliance, Audit and Validation, Regulatory Affairs
You may know that the Medical Device Coordination Group (MDCG) has released a Q&A document related to previously released guideline - MDCG 2020-4: guidance on temporary and extraordinary measures related to medical device Notified Body audits during COVID-19 quarantine orders and travel restrictions.
- December 21, 2020 Medical Devices
Building and managing an efficient Quality Management System (QMS) is a crucial step for medical device enterprises willing to deliver the right product to the customers. As almost all major markets across the globe made it a thumb rule to go by a compliant QMS while registering the products, it is indeed a primary requirement for manufacturers to maintain QMS for a successful product launch.
- December 21, 2020 Medical Devices, Regulatory Affairs
As the EU MDR transition deadline is inching closer, manufacturers must execute the labeling requirements with utmost priority and caution and must ensure high standards of quality, and safety for compliance. Prior to execution, understanding the new labeling requirements and accurate implementation is of paramount importance. Any labeling errors can impede the progress, cause product recalls and lead to costly delays.