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
- 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).
- October 21, 2022 Medical Devices, Regulatory Affairs
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.
- October 18, 2022 Biologicals, Regulatory Labeling
In the era of personalized medications, precision medicine revolutionized the delivery of biologicals, ensuring safety and efficacy by comprehending the product’s effect at an individual level. Pharmacogenomics (PGx) is one of the components of precision medicine owing to its role in optimal dose selection and effective, dose-responsive, individual identification that can avoid adverse reactions.
- October 18, 2022 Medical Devices, Regulatory Affairs
Digital health technologies have become a focus for investors in the healthcare industry in China. The NMPA has set various laws and policies regulating digital health technologies. The NMPA considers digital devices such as healthcare apps, wearables, and Software as a Medical Device (SaMD) as medical devices under the Medical Device Regulation (Order #739).
- October 17, 2022 Pharmaceuticals, Regulatory Medical Writing
Child-resistant Packaging (CRP) is a type of packaging that is difficult for young children to open (or gain access to the contents) as opposed to adults. CRP reduces child mortality/adverse effects from the unintentional ingestion of oral prescription drugs.
- October 17, 2022 Medical Devices, Regulatory Affairs
Technical writing is a profession that only seems easy and straightforward. It requires finer skills and involves the usage of various tools to create the right content and get the information that is apt and easy to understand. The challenge for technical writing begins with an in-depth understanding of the product or service, staying abreast of its functionalities, and knowing and understanding the target audience.
- October 14, 2022 Medical Devices, Regulatory Affairs
Technical writing or technical documentation has evolved into a subject of growing significance in the world of written communication. Consider it as a natural offshoot of the knowledge-based economy, given its specialized nature, especially in the developed world.
- October 14, 2022 Pharmaceuticals, Regulatory Artwork Services
With digitalization taking up the world, some might say that paper leaflets are an outdated approach. Paper leaflet copies can become outdated whenever new safety or effectiveness information is released, making it challenging for manufacturers to update their leaflets.