Risk management is a critical activity across all phases of the medical device lifecycle as it directly affects the safety and well-being of patients. Risks are unavoidable; however, they can be curtailed if companies are aware of impending hazards and follow effective risk management procedures.
- November 8, 2022 Medical Devices, Regulatory Affairs
- November 8, 2022 Medical Devices, Regulatory Affairs
Mexico is one of the largest importers and a remarkable manufacturer of medical devices in the world and specifically gripping in Latin America. Mexico, offering an attractive market for foreign companies, is ministered by the Federal Commission for the Protection against Sanitary Risk (COFEPRIS), the Regulatory Body of the Mexican Government. In April 2022, COFEPRIS announced new rules for medical device submission.
- November 8, 2022 Pharmaceuticals, Regulatory Affairs
Country-specific requirements and maintaining documents containing different quality information for the same product have always been challenging. Excessive inventory segregation, the likelihood of manufacturing and Regulatory compliance errors, and varying submission, evaluation, and deployment deadlines all add to the complexity of product supply chain regulation worldwide.
- November 7, 2022 Regulatory Affairs, Regulatory Software & Services
Life sciences is a highly regulated industry, full of sensitive information that is required to be maintained efficiently. Documents are the backbone of any life sciences segment since it establishes the quality of processes and assurance of safety.
- October 31, 2022 Pharmaceuticals, Regulatory Artwork Services, Regulatory Affairs
Despite being one of the most regulated industries in the world, the prevalence of counterfeit drugs is a sad reality in the emerging markets of the pharmaceutical industry. According to a report by the Authentication Solution Provider’s Association (ASPA), the number of counterfeit incidents in India increased by an average of 20% on a year-to-year growth between 2018 to 2020 and 17% between 2019 to 2020.
- October 31, 2022 Generics, Regulatory Affairs
Competitive generics are known to be a boon as they pave the way to a lucrative market, provided drug manufacturers can decode the challenging and complicated drug development. Although drug development technologies are constantly evolving, we are yet to comprehend the outcomes of Competitive Generic Therapy (CGT).
- October 28, 2022 Medical and Scientific Communication, Pharmaceuticals, Regulatory Medical Writing
The pharmaceutical and Life Sciences sectors have seen a steady increase in the need for Medical Writing. Patents have been expiring, Regulatory standards have changed quickly, and spending on research and development has been rising constantly. Because of this, the necessity to continuously adapt, produce, maintain, and update medical material has evolved.
- October 21, 2022 Medical Devices, Regulatory Affairs
Medical devices in South Korea are regulated by the Ministry of Food and Drugs Safety (MFDS), formally known as the Korean Food and Drug Administration (KFDA). MFDS requires all foreign manufacturers wishing to market their devices in South Korea to appoint a Korean License Holder (KLH) to register their devices with the MFDS.
- October 21, 2022 Medical Devices, Regulatory Affairs
Medical device manufacturers must include required documentation with every product to help consumers understand its use. This documentation, sometimes, can have a few hundred pages, which is daunting for consumers. Quick reference guides are curated to cover all necessary product information, and the consumers may not have to wade through a ton of content to find it.
- October 21, 2022 Medical Devices, Regulatory Affairs
The Medical Device Single Audit Program (MDSAP) allows a recognized Auditing Organization (AO) to conduct a single audit of a medical device manufacturer’s Quality Management System (QMS). It furnishes relevant Regulatory requirements for five countries, i.e., Brazil (ANVISA), USA (FDA), Japan (PMDA), Canada (Health Canada), and Australia (TGA).