• COFEPRIS’ New Requirements for Online Submission of Medical Devices

    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...

  • ICH Q12- Transforming Global Regulatory Post-Approval Submissions

    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. As a result...

  • eDMS - The driving force for Successful Regulatory Operations

    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. The growing volume of documents in organizations exponentially increases the demand to replace traditional and manual documentation practices to...

  • 360 Degree Packaging Security: Brand Protection in the Emerging Markets

    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...

  • The CGT Exclusivity: An Incentivized Pathway to ANDA Submission
    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). When we discuss the disease burden, the size and volume of the patient...

  • Adopting AI in 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.

    Medical Writing is a highly...

  • Top 10 FAQs about Korean License Holder (KLH)

    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. The current article answers the major questions posed by the device...

  • User-Friendly Quick Reference Guides for Medical Device Manufacturers

    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.

    A quick reference...

  • Top FAQs about Medical Device Single Audit Program (MDSAP)

    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). Aside from the participating Regulatory...

  • Classifying the Undefined Devices under EU MDR

    The medical devices and In Vitro Diagnostic devices (IVDs) under the European Union Medical Device Regulation (EU MDR) 2017/745 and In Vitro Diagnostic Devices Regulations (IVDR) 2017/746 are categorized into four (04) classes and twenty-two (22) rules (MDR)/ seven (07) rules (IVDR). Compared to the previous scope of the product in the Directives, the current regulation has expanded its scope...

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