The biggest challenge that creative medical device Research and Development (R&D) programs face is that of balancing clinical evidence with early patient access. To address this, a new review system was proposed in Japan, to pace up device clearance while maintaining safety and efficacy. This benefits patients who are inflicted with life-threatening diseases that lack effective treatments.
As technology continues to advance, so do the medical devices that are used to sustain life. While in South Korea, various types of medical devices capable of communication have been developed, the development is accompanied by the risk of cybersecurity threats such as hacking of medical devices and information leaks. These threats are not only applicable to property loss, but also to patients’ lives, and that is why safeguarding medical device cybersecurity is a core concern.
Software as a Medical Device (SaMD) is an emerging category of medical devices that has been experiencing rapid growth in recent years. This category of devices includes medical device software applications designed for medical purposes, such as diagnosis, disease prevention, treatment, and monitoring.
An Overview of Document Registration for Medical Devices in Turkey
In Turkey, document registration is a crucial step in obtaining Regulatory approval for medical devices. The Türkiye İlaç ve Tıbbi Cihaz Kurumu (TITCK), or the Turkish Medicines and Medical Devices Agency, oversees this process, ensuring strict adherence to the country’s regulations and standards. Manufacturers and importers must undergo a comprehensive evaluation prior to introducing their devices in the Turkish market.
Unlocking Market Access: The Impact of Official Classification with MOHAP on Medical Device Registration in the UAE
Medical device classification with the Ministry of Health and Prevention (MOHAP) in the United Arab Emirates (UAE) is vital for ensuring patient safety, achieving Regulatory compliance, and determining registration requirements. The classification is risk-based, with four (04) types (Class I, IIa, IIb, and III), and is overseen by MOHAP’s Registration and Drug Control Department. It ensures compliance, streamlines registration, and safeguards public health.
Medical device grouping in India is a Regulatory process that enables manufacturers and importers to register multiple devices under a single license. Regulated by the Central Drugs Standard Control Organization (CDSCO), the grouping guidelines specify how companies can group their medical devices for import or manufacture clearance. This classification simplifies the application process and saves time and costs for license applicants.
The Guidelines for Registration Review of Radio Frequency (RF) beauty devices in China is a consolidated document that guides registration applicants and technical review departments on how to prepare registration application materials for RF beauty devices.
These guidelines are meant specifically for RF beauty devices, which include devices used for skin treatment, fat reduction, and other cosmetic purposes; such devices use high-frequency current to act on the human body.
In Vitro Diagnostic (IVD) devices play a crucial role in healthcare by providing valuable information for disease diagnosis, patient monitoring, and treatment decisions. The European Union's In Vitro Diagnostic Regulation (IVDR) 2017/746 introduced a new classification system for IVDs.
Complaint handling is an integral part of medical device companies’ Quality Management System (QMS). It involves receiving, investigating, and resolving customer complaints related to medical device products and services provided by an organization. Such complaints are related to the safety, performance, or effectiveness of medical devices, as per ISO 13485. Companies must address complaints promptly and effectively to maintain customer satisfaction and uphold Regulatory compliance.