The Brazilian Medical Devices Market is growing significantly and is expected to reach USD 1.8 billion by 2023. Medical devices in Brazil are regulated by the National Health Surveillance Agency (ANVISA). Some medical devices require additional safety certification and accreditation by the National Institute of Metrology, Standardization and Industrial Quality (INMETRO) before the registration at ANVISA.
- July 29, 2021 Medical Devices
- July 29, 2021 Medical Devices
To ensure the safety and efficacy of medical devices entering the US market, the US FDA requires every manufacturer to submit a mandatory 510(k) pre-market notification. It is mainly applicable for Class II devices and a few Class I and Class III devices and is based on the principle of substantial equivalence.
- July 29, 2021 Medical Devices
Implementing and maintaining a Quality Management System (QMS) is mandatory to launch medical devices in the global markets. Having an effective QMS should embody all the procedures and processes covering all aspects from design to production, packaging and distribution.
- July 28, 2021 Regulatory Affairs
Modern-day research and advancements have changed the dynamics of the life sciences landscape. Governments & Health Authorities are constantly facing new challenges amidst the paradigm shift from the pre-COVID era to the present-day scenario. Such a challenging environment brought about an end-to-end evolution of the industry, from new drug development to supply chain management.
- July 28, 2021 Medical Devices
With the rapid development and integration of software into medical devices, there is an increase in data breaches and cyber-attacks on public and private medical devices information systems. This ultimately leads to unwanted exposure of an organization’s confidential information and patient’s data and creates chaos in information security and legal systems.
- July 28, 2021 Chemicals, Regulatory Affairs, Regulatory Labeling
Occupational Safety and Health Administration (OSHA), in alignment with the United Nations’ Globally Harmonized System of Classification and Labeling of Chemicals (GHS), has adopted new hazardous chemical labeling requirements as a part of its recent revision of the Hazard Communication Standard, 29 CFR 1910.1200 (HCS).
- July 27, 2021 Regulatory Affairs
Regulatory practices across the globe have a significant role in ensuring that the drug preparation/product sourced for a disease is safe for consumption and effective against the targeted ailment. As of the current pandemic situation, Health authorities across the globe are granting emergency use authorizations based on the preliminary data obtained through phase III clinical trials.
- July 27, 2021 Chemicals, Regulatory Affairs
The chemical industry has played a pivotal role in boosting the Indian economy and providing livelihood to more than two (02) million people. As the Indian Government intends to transform India into a global manufacturing hub for chemicals, the industry is set to witness major positive shifts. India, indeed, has become a key investment destination for chemical manufacturers.
- July 27, 2021 Medical Devices
Labeling has paramount importance in the medical device industry for ensuring high standards of quality and safety. The labels help educate the end-users or patients about how to use the device, who should use it, how to operate the device safely and what risks it could pose. Therefore, medical device manufacturers must gain a clear understanding and comply with the updated Health Authorities labeling regulations.
- July 22, 2021 Medical Devices, Regulatory Affairs
With the growing economy and population, the demand for safe and effective healthcare facilities has increased in Sri Lanka. National Medicines Regulatory Authority (NMRA) of Sri Lanka is responsible for assuring that the medical devices imported into Sri Lanka pertain to high standards of safety, quality and efficacy.