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.

The Turkish Medicines and Medical Devices Agency (TMMDA) is the Regulatory Agency/Health Authority (HA) of the Government of Turkey. It acts as the Regulatory authority for medicines, medical devices, health products, personal care products, and cosmetics in Turkey. Recently, the TMMDA has published a guidance document dedicated to withdrawals and recalls of both general and in vitro diagnostics.

Post-market surveillance (PMS) is a system through which surveillance of adverse events and malfunctions of health products in the post-market phase are carried out, aimed at recommending the adoption of measures to ensure the protection and promotion of public health.

The core objective of post-market monitoring and vigilance is to enhance the well-being and safety of patients, healthcare professionals, users, and others by minimizing the occurrence of adverse events.

The monitoring of post-market performance aims to identify trends or issues that were previously undisclosed.

The European Union Medical Device Regulation (EU MDR) has replaced the Medical Device Directive (MDD) and the Active Implantable Medical Device Directives (AIMDD), introducing several significant changes in the regulations. One of the key elements that has been replaced is Essential Requirements (ER). ER have now been replaced by General Safety and Performance Requirements (GSPR). Although it might seem that both lay out the same requirements, GSPR lays out more stringent requirements. For instance, under GSPR, manufacturers are now required to demonstrate and analyze more clinical data.

A Performance Evaluation Report (PER) is a comprehensive clinical document that demonstrates the safety and performance of In Vitro Diagnostic (IVD) devices. It is mandatory for manufacturers to submit this document to place their IVDs in the European Union (EU) market. The PER is built on the foundation of the following three (03) pillars of data demonstration:

Clinical evaluation of medical devices is one of the key steps for receiving the Conformité Européenne (CE), or the European Conformity certification in the European Union (EU) geography. The objective behind clinical evaluation of medical devices is to ensure patient/user safety, drive manufacturers and Notified Bodies (NBs) towards evidence-based decision-making, and at the same time inform them about Post-marketing Surveillance (PMS) activities.

Artificial Intelligence (AI) has the potential to revolutionize the healthcare industry by improving the accuracy, efficiency, and speed of diagnosis and treatment. However, the development and deployment of AI medical devices also pose significant Regulatory challenges. In response, China's National Medical Products Administration (NMPA) has issued guidelines for registering and reviewing AI medical devices. This review will provide a comprehensive overview of these guidelines, their implications, and their potential impact on AI medical devices in China.

The Unique Device Identification (UDI) system is an international standard that assigns a unique code to each medical device to improve patient safety and streamline product tracking and recall. In China, the National Medical Products Administration (NMPA) has implemented UDI guidelines and regulations for medical devices to enhance safety and quality control.

With the implementation of the European Union (EU) Medical Device Regulation (MDR) 2017/745, one of the areas that caught the most attention was the new Post-Market Surveillance (PMS) system for devices. Establishing a PMS for a device has become a mandatory task for manufacturers. The objective behind this stringent requirement is to ensure device safety throughout the product’s lifecycle. Post-market Clinical Follow-up (PMCF) is part of the PMS and refers to the evaluation and collection of data for the devices placed in the market.